New York, New York – February 28, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert update for Alimera Sciences, Inc. (NasdaqGM: ALIM), following up on yesterday’s gains, with a monster run in the stock today, moving up another 70% on over 3.6 Million shares in morning trading.
The Company reported today on the positive outcome of the Decentralized Procedure (DCP) for ILUVIEN(R) in Europe. The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all the Concerned Member States (CMS) that ILUVIEN is approvable.
ILUVIEN is Alimera's sustained release intravitreal implant that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic Diabetic Macular Edema.
According to the Company:
ILUVIEN(R) expected to be the first sustained release pharmaceutical in the European Union to treat diabetic macular edema (DME)
ILUVIEN expected to be indicated for chronic DME considered insufficiently responsive to available therapies
Investorideas.com Newswire
Alimera Sciences, Inc., (NASDAQ:ALIM) based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its advanced product candidate, ILUVIEN, is an intravitreal insert containing fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease. ILUVIEN is in development for the treatment of DME, a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - Source - www.Investorideas.com
Tuesday, February 28, 2012
Biodefense Stock News: Vista Partners Updates Coverage on PositiveID Corporation (OTCBB:PSID); $0.38 Target Price
SAN FRANCISCO - February 28, 2012 - (Investorideas.com Newswire) Vista Partners announced today that it has updated coverage on PositiveID Corporation (OTCBB: PSID) ("The Company" or "PSID"); and revised its twelve month target price to $0.38. Ross Silver, Principal Analyst at Vista Partners stated, "The Company's MicroFluidic Systems subsidiary is attempting to secure a portion of the $3.1B Homeland Defense BioWatch pathogen detection contract. The Company is jointly demonstrating its M-BAND device with The Boeing Company and Hamilton Sundstrand at a bioterrorism conference this week." Mr. Silver continues, "We believe the Company's diabetes management products; both FDA approved and under clinical development, could become standards of care. The Company has entered into a partnership with IDEAL LIFE, Inc., a health management leader, to bring iglucose to market. IDEAL LIFE will market iglucose to its large network of customers, including insurance companies, hospitals, and other health care providers. By partnering with IDEAL LIFE, the Company hopes to accelerate market adoption of iglucose. The company anticipates iglucose to be commercially available in the first half of 2012."
To download a FREE copy of the PositiveID Corporation research report, please visit http://www.vistapglobal.com and click the "download research" icon to gain access to the report.
About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista Partners LLC has built a name for itself in the small cap space due to its selection of profitable investment ideas.
Disclaimer & Disclosure:
For a full list of disclaimers and disclosures, please visit our website www.vistapglobal.com.
Contact:
877.215.4813 or info@vistapglobal.com
PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
Visit the company profile: http://www.investorideas.com/CO/PSID/
Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
To download a FREE copy of the PositiveID Corporation research report, please visit http://www.vistapglobal.com and click the "download research" icon to gain access to the report.
About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista Partners LLC has built a name for itself in the small cap space due to its selection of profitable investment ideas.
Disclaimer & Disclosure:
For a full list of disclaimers and disclosures, please visit our website www.vistapglobal.com.
Contact:
877.215.4813 or info@vistapglobal.com
PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
Visit the company profile: http://www.investorideas.com/CO/PSID/
Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Monday, February 27, 2012
Biopharmaceutical Stock to Watch; Alimera Sciences (NASDAQ:ALIM) Gains over 35%
New York, New York – February 27, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for Alimera Sciences, Inc. (NasdaqGM: ALIM), trading up at $2.3092, gaining 0.5992 or (35.04%) as of 1:22PM EST on over 800,000 shares.
The Company announced Friday that Dan Myers, president and chief executive officer, will present at the Citi 2012 Global Health Care Conference at 1:30 P.M. ET on Wednesday, February 29, 2012 at The Waldorf Astoria Hotel in New York City.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its advanced product candidate, ILUVIEN, is an intravitreal insert containing fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease. ILUVIEN is in development for the treatment of DME, a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - Source – www.Investorideas.com
The Company announced Friday that Dan Myers, president and chief executive officer, will present at the Citi 2012 Global Health Care Conference at 1:30 P.M. ET on Wednesday, February 29, 2012 at The Waldorf Astoria Hotel in New York City.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its advanced product candidate, ILUVIEN, is an intravitreal insert containing fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease. ILUVIEN is in development for the treatment of DME, a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Sign up for the free investor news and stock alerts http://www.investorideas.com/Resources/Newsletter.asp
Research biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - Source – www.Investorideas.com
Friday, February 24, 2012
Biotech Stocks Sector Snapshot and Podcast: VVUS, INFI, SNTS on the Move
New York, NY - February 24, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for notable sector gainers VIVUS, Inc. (NASDAQ: VVUS), Infinity Pharmaceuticals (Nasdaq:INFI) and Santarus, Inc. (NASDAQ:SNTS).
Investorideas.com sector snapshot podcast for biotech stocks, for trading as of Thursday February 23 rd:
Listen to the Investorideas.com Podcast in MP3
VIVUS, Inc. (NASDAQ: VVUS) closed up with massive gains at $18.73, up $8.18(77.54%) with after hours trading moving it to $!8.95, up another 0.22 (1.17%).The day's high on the stock was $21.44 on over 58 Million shares. The stock's monster move was on news that the FDA Advisory Committee had recommended the approval of Qnexa for the treatment of obesity in adults
Infinity Pharmaceuticals (NASDAQ:INFI) closed up at $7.15, up 0.84 or (13.31%). The Company announced on Tuesday that they will be presenting at the Cowen and Company 32nd Annual Health Care Conference on Monday, March 5th
Santarus, Inc. (NASDAQ:SNTS) finished the day at $5.01 up 0.51(11.33%). The Company announced Wednesday that they have entered into a settlement agreement with Lupin to resolve pending patent litigation involving GLUMETZA
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. www.vivus.com.
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
Source - www.Investorideas.com
Investorideas.com sector snapshot podcast for biotech stocks, for trading as of Thursday February 23 rd:
Listen to the Investorideas.com Podcast in MP3
VIVUS, Inc. (NASDAQ: VVUS) closed up with massive gains at $18.73, up $8.18(77.54%) with after hours trading moving it to $!8.95, up another 0.22 (1.17%).The day's high on the stock was $21.44 on over 58 Million shares. The stock's monster move was on news that the FDA Advisory Committee had recommended the approval of Qnexa for the treatment of obesity in adults
Infinity Pharmaceuticals (NASDAQ:INFI) closed up at $7.15, up 0.84 or (13.31%). The Company announced on Tuesday that they will be presenting at the Cowen and Company 32nd Annual Health Care Conference on Monday, March 5th
Santarus, Inc. (NASDAQ:SNTS) finished the day at $5.01 up 0.51(11.33%). The Company announced Wednesday that they have entered into a settlement agreement with Lupin to resolve pending patent litigation involving GLUMETZA
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. www.vivus.com.
Get biotech news and stock alerts
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Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
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Biodefense Stocks to Watch in 2012; PositiveID (OTCBB:PSID) and Northrop Grumman (NYSE: NOC) Opportunities with BioWatch
New York, NY - February 24, 2012 - (Investorideas.com Newswire) Investorideas.com, a leader in research for independent investors presents an investor snapshot of Homeland Security and Biodefense stocks , PositiveIDCorporation (OTCBB: PSID) and Northrop Grumman (NYSE: NOC), two potentially qualified biodetector systems suppliers for BioWatch Gen-3.
The Department of Homeland Security Office of Procurement Operations anticipates soliciting final Phase II RFP for the first or second quarter of FY 2012.The Gen-3 detection system will be a fully autonomous network of biodetectors that will continuously monitor the air for biothreat agents.
In a recent interview with Investorideas.com. Mr. William J. Caragol, Chairman and Chief Executive Officer of PositiveIDCorporation (OTCBB: PSID) noted, "Our MicroFluidic Systems ("MFS") subsidiary, is a leader in biothreat detection technologies and molecular diagnostic systems, and developed its M-BAND technology under contract from DHS over the past eight years. We believe our M-BAND, a Microfluidics-based Bioagent Autonomous Networked Detector, is one of only two technologies that is compatible with DHS' procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP. This opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID. "
PositiveID Corporation (OTCBB: PSID) announced it will present its M-BAND (Microfluidics-based Bioagent Autonomous Networked Detector) system at the 10th Annual American Society for Microbiology ("ASM") Biodefense and Emerging Diseases Research Meeting, to be held February 26-29, 2012, in Washington, DC at the Omni Shoreham Hotel. PositiveID will jointly exhibit M-BAND with The Boeing Company and Hamilton Sundstrand.
Northrop Grumman's (NYSE: NOC) biodefense division will be a key player in Biowatch as it moves forward, with previous contracts announced back in 2010. Northrop delivered critical assay technology to DHS as part of the company's BioWatch Gen-3 contract .The assay represents the key technological component of Northrop Grumman's BioWatch Gen-3 system.
According to the company's press release, Northrop Grumman's Advanced Concepts & Technologies Division is providing its Next-Gen Automated Detection Systems (NG-ADS) for independent laboratory and field testing at military and national laboratories.
"Automating the bio-detection process in these next generation instruments will provide much earlier warning of a bio-terrorism attack," said Dave Tilles, vice president of homeland defense programs at Northrop Grumman. "It will operate 24 hours per day, 365 days per year, in select cities across the nation. Earlier warning will allow the nation's public health and safety officials to reduce exposure, distribute medication sooner and proactively manage the response to a bio-threat."
As the RFP for Biowatch moves forward in 2012, investors can follow the money flow from DHS as qualified biodetector systems are contracted and deployed.
More info on Biowatch; follow the updates:
https://www.fbo.gov/index?s=opportunity&mode=form&id=2372ab5f30917fdbacca73f3fa5f0e9c&tab=core&_cview=1
Learn more about PSID at Investorideas.com
http://www.investorideas.com/CO/PSID/
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation ( OTCBB:PSID ) featured biotech company on Investorideas.com for 3 months effective January 30, 2012. Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Contact Investorideas.com 800 665 0411
PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
Visit the company profile: http://www.investorideas.com/CO/PSID/
The Department of Homeland Security Office of Procurement Operations anticipates soliciting final Phase II RFP for the first or second quarter of FY 2012.The Gen-3 detection system will be a fully autonomous network of biodetectors that will continuously monitor the air for biothreat agents.
In a recent interview with Investorideas.com. Mr. William J. Caragol, Chairman and Chief Executive Officer of PositiveIDCorporation (OTCBB: PSID) noted, "Our MicroFluidic Systems ("MFS") subsidiary, is a leader in biothreat detection technologies and molecular diagnostic systems, and developed its M-BAND technology under contract from DHS over the past eight years. We believe our M-BAND, a Microfluidics-based Bioagent Autonomous Networked Detector, is one of only two technologies that is compatible with DHS' procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP. This opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID. "
PositiveID Corporation (OTCBB: PSID) announced it will present its M-BAND (Microfluidics-based Bioagent Autonomous Networked Detector) system at the 10th Annual American Society for Microbiology ("ASM") Biodefense and Emerging Diseases Research Meeting, to be held February 26-29, 2012, in Washington, DC at the Omni Shoreham Hotel. PositiveID will jointly exhibit M-BAND with The Boeing Company and Hamilton Sundstrand.
Northrop Grumman's (NYSE: NOC) biodefense division will be a key player in Biowatch as it moves forward, with previous contracts announced back in 2010. Northrop delivered critical assay technology to DHS as part of the company's BioWatch Gen-3 contract .The assay represents the key technological component of Northrop Grumman's BioWatch Gen-3 system.
According to the company's press release, Northrop Grumman's Advanced Concepts & Technologies Division is providing its Next-Gen Automated Detection Systems (NG-ADS) for independent laboratory and field testing at military and national laboratories.
"Automating the bio-detection process in these next generation instruments will provide much earlier warning of a bio-terrorism attack," said Dave Tilles, vice president of homeland defense programs at Northrop Grumman. "It will operate 24 hours per day, 365 days per year, in select cities across the nation. Earlier warning will allow the nation's public health and safety officials to reduce exposure, distribute medication sooner and proactively manage the response to a bio-threat."
As the RFP for Biowatch moves forward in 2012, investors can follow the money flow from DHS as qualified biodetector systems are contracted and deployed.
More info on Biowatch; follow the updates:
https://www.fbo.gov/index?s=opportunity&mode=form&id=2372ab5f30917fdbacca73f3fa5f0e9c&tab=core&_cview=1
Learn more about PSID at Investorideas.com
http://www.investorideas.com/CO/PSID/
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation ( OTCBB:PSID ) featured biotech company on Investorideas.com for 3 months effective January 30, 2012. Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Contact Investorideas.com 800 665 0411
PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
Visit the company profile: http://www.investorideas.com/CO/PSID/
Thursday, February 23, 2012
Biopharmaceutical Stock to Watch: VIVUS (NASDAQ: VVUS) Massive Move on FDA Approval of Qnexa®
New York, NY - February 23, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for biopharmaceutical stock VIVUS, Inc. (NASDAQ: VVUS). The stock is trading up at$18.92 8.37(79.34%) with a day high of $21.44 on volume of over 51 Million shares.
VIVUS, Inc. (NASDAQ: VVUS) reported yesterday that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. www.vivus.com.
Get biotech news and stock alerts
http://www.investorideas.com/ Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/ BIS/Stock_List.asp
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InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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VIVUS, Inc. (NASDAQ: VVUS) reported yesterday that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. www.vivus.com.
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Tuesday, February 21, 2012
Biodefense Stock News: PositiveID (OTCBB:PSID) to Present M-BAND at ASM Biodefense and Emerging Diseases Research Meeting February 26-29
DELRAY BEACH, Fla., February 21, 2012 - (Investorideas.com Newswire) PositiveID Corporation's (OTCBB: PSID) subsidiary MicroFluidic Systems (“MFS”), a developer of molecular diagnostic systems, announced today it will present its M-BAND (Microfluidics-based Bioagent Autonomous Networked Detector) system at the 10 th Annual American Society for Microbiology (“ASM”) Biodefense and Emerging Diseases Research Meeting, to be held February 26-29, 2012, in Washington, DC at the Omni Shoreham Hotel. PositiveID will jointly exhibit M-BAND with The Boeing Company (NYSE:BA) and Hamilton Sundstrand.
M-BAND, developed under contract for the Department of Homeland Security by MFS, is an early warning system designed to detect the intentional release of aerosolized biological agents . It runs autonomously for up to 30 days, continuously analyzing air samples, typically in high-traffic areas, for the detection of bacteria, viruses, and toxins with results in as little as three hours. Results from individual M-BAND instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in aggregate. Designed with a high level of operational flexibility, M-BAND can be remotely set to detect for DNA-based pathogens alone, with or without either RNA-based organisms or toxins, or for all three types of pathogens simultaneously at remotely programmable intervals.
According to the ASM, approximately 1,000 leaders and decision makers in the field of biodefense will participate in the Biodefense and Emerging Diseases conference to discuss the critical research necessary to defend against the growing threat of bioterrorism and shape the future of the biodefense research agenda.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that PositiveID will present its M-BAND system at the ASM Biodefense and Emerging Diseases Research Meeting; the likelihood that PositiveID will jointly exhibit M-BAND with The Boeing Company and Hamilton Sundstrand; the likelihood that approximately 1,000 leaders and decision makers in the field of biodefense will participate in the Biodefense and Emerging Diseases conference to discuss the critical research necessary to defend against the growing threat of bioterrorism and shape the future of the biodefense research agenda; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize M-BAND; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
Published at the Investorideas.com Newswire and syndicated blogs
Learn more about PSID at Investorideas.com
http://www.investorideas.com/CO/PSID/
Disclaimer /Disclosure : Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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M-BAND, developed under contract for the Department of Homeland Security by MFS, is an early warning system designed to detect the intentional release of aerosolized biological agents . It runs autonomously for up to 30 days, continuously analyzing air samples, typically in high-traffic areas, for the detection of bacteria, viruses, and toxins with results in as little as three hours. Results from individual M-BAND instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in aggregate. Designed with a high level of operational flexibility, M-BAND can be remotely set to detect for DNA-based pathogens alone, with or without either RNA-based organisms or toxins, or for all three types of pathogens simultaneously at remotely programmable intervals.
According to the ASM, approximately 1,000 leaders and decision makers in the field of biodefense will participate in the Biodefense and Emerging Diseases conference to discuss the critical research necessary to defend against the growing threat of bioterrorism and shape the future of the biodefense research agenda.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that PositiveID will present its M-BAND system at the ASM Biodefense and Emerging Diseases Research Meeting; the likelihood that PositiveID will jointly exhibit M-BAND with The Boeing Company and Hamilton Sundstrand; the likelihood that approximately 1,000 leaders and decision makers in the field of biodefense will participate in the Biodefense and Emerging Diseases conference to discuss the critical research necessary to defend against the growing threat of bioterrorism and shape the future of the biodefense research agenda; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize M-BAND; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
Published at the Investorideas.com Newswire and syndicated blogs
Learn more about PSID at Investorideas.com
http://www.investorideas.com/CO/PSID/
Disclaimer /Disclosure : Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
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Thursday, February 16, 2012
Medical Technology Stock Alert; PositiveID (OTCBB:PSID) Achieves Positive Preliminary Results From Diabetes Research Institute Study at the University of Miami
DELRAY BEACH, Fla. - February 13, 2012 (Investorideas.com newswire) - PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management, announced today positive preliminary results from its biotransport research study with the Diabetes Research Institute ("DRI") at the University of Miami relating to PositiveID's GlucoChip(TM). GlucoChip is a glucose-sensing implantable microchip, currently under development with partner RECEPTORS LLC, for individuals with diabetes. Preliminary results demonstrate that the membrane materials to be used with GlucoChip allow for successful movement of glucose from body fluids.
PositiveID's first animal studies were designed to test the membrane materials that will be the interface between the glucose sensing device and the in vivo environment by evaluating the ability of glucose to pass through the membrane to the sensing device (glucose transport).
Robert E. Carlson, Ph.D., President and Chief Scientific Officer of RECEPTORS, said, "These first studies were successfully completed with the demonstration that a glucose tracer readily enters the device from surrounding body fluids. We are currently implementing the next phase of these studies, which will focus in more detail on both the kinetics of transport, which will determine how quickly the device will be able to respond to changes in glucose levels in the body, and on the long-term biocompatibility of the membrane."
PositiveID Chairman and CEO William J. Caragol said, "We believe the preliminary results from our research study at the DRI are not only positive but also promising as we proceed with our development. By achieving early confirmation that the membrane materials we will use with GlucoChip allow for movement of glucose from fluids in the body into the glucose-sensing device, we have begun to eliminate one of the significant hurdles of this potentially ground-breaking development project."
PositiveID and RECEPTORS LLC have completed prototype development of a stable and reproducible, closed-cycle continuous glucose-sensing system, which is the mission-critical component of GlucoChip. Continued positive results from the biocompatibility and biotransport study would position PositiveID to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip.
GlucoChip is based on the PositiveID's Patent No. 7,125,382 for an "Embedded Bio-Sensor System." The Embedded Bio-Sensor System patent covers a bio-sensor system that utilizes radio frequency identification technology and includes a remote transponder in wireless communication with an implantable, passively-powered, on-chip transponder. PositiveID now has five patents and patents pending surrounding the development of GlucoChip.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
The PositiveID Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7717
Statements about PositiveID's future expectations, including the likelihood that preliminary results demonstrate that the membrane materials to be used with GlucoChip allow for successful movement of glucose from body fluids; the likelihood that these first studies were successfully completed with the demonstration that a glucose tracer readily enters the device from surrounding body fluids; the likelihood that the next phase of these studies, which will focus in more detail on both the kinetics of transport, will determine how quickly the device will be able to respond to changes in glucose levels in the body, and on the long-term biocompatibility of the membrane; the likelihood that the preliminary results from PositiveID's research study at the DRI are not only positive but also promising as the company proceeds with its development; the likelihood that by achieving early confirmation that the membrane materials PositiveID will use with GlucoChip allow for movement of glucose from fluids in the body into the glucose-sensing device, the company has begun to eliminate one of the significant hurdles of this exciting development project; the likelihood that the prototype development of a stable and reproducible, closed-cycle continuous glucose-sensing system is the mission-critical component of GlucoChip; the likelihood that continued positive results from the biocompatibility and biotransport study would position the company to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully complete this research study of the membrane materials to be used in GlucoChip of Easy Check; PositiveID's ability to complete development of and commercialize GlucoChip; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
CONTACT:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
PositiveID's first animal studies were designed to test the membrane materials that will be the interface between the glucose sensing device and the in vivo environment by evaluating the ability of glucose to pass through the membrane to the sensing device (glucose transport).
Robert E. Carlson, Ph.D., President and Chief Scientific Officer of RECEPTORS, said, "These first studies were successfully completed with the demonstration that a glucose tracer readily enters the device from surrounding body fluids. We are currently implementing the next phase of these studies, which will focus in more detail on both the kinetics of transport, which will determine how quickly the device will be able to respond to changes in glucose levels in the body, and on the long-term biocompatibility of the membrane."
PositiveID Chairman and CEO William J. Caragol said, "We believe the preliminary results from our research study at the DRI are not only positive but also promising as we proceed with our development. By achieving early confirmation that the membrane materials we will use with GlucoChip allow for movement of glucose from fluids in the body into the glucose-sensing device, we have begun to eliminate one of the significant hurdles of this potentially ground-breaking development project."
PositiveID and RECEPTORS LLC have completed prototype development of a stable and reproducible, closed-cycle continuous glucose-sensing system, which is the mission-critical component of GlucoChip. Continued positive results from the biocompatibility and biotransport study would position PositiveID to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip.
GlucoChip is based on the PositiveID's Patent No. 7,125,382 for an "Embedded Bio-Sensor System." The Embedded Bio-Sensor System patent covers a bio-sensor system that utilizes radio frequency identification technology and includes a remote transponder in wireless communication with an implantable, passively-powered, on-chip transponder. PositiveID now has five patents and patents pending surrounding the development of GlucoChip.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
The PositiveID Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7717
Statements about PositiveID's future expectations, including the likelihood that preliminary results demonstrate that the membrane materials to be used with GlucoChip allow for successful movement of glucose from body fluids; the likelihood that these first studies were successfully completed with the demonstration that a glucose tracer readily enters the device from surrounding body fluids; the likelihood that the next phase of these studies, which will focus in more detail on both the kinetics of transport, will determine how quickly the device will be able to respond to changes in glucose levels in the body, and on the long-term biocompatibility of the membrane; the likelihood that the preliminary results from PositiveID's research study at the DRI are not only positive but also promising as the company proceeds with its development; the likelihood that by achieving early confirmation that the membrane materials PositiveID will use with GlucoChip allow for movement of glucose from fluids in the body into the glucose-sensing device, the company has begun to eliminate one of the significant hurdles of this exciting development project; the likelihood that the prototype development of a stable and reproducible, closed-cycle continuous glucose-sensing system is the mission-critical component of GlucoChip; the likelihood that continued positive results from the biocompatibility and biotransport study would position the company to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully complete this research study of the membrane materials to be used in GlucoChip of Easy Check; PositiveID's ability to complete development of and commercialize GlucoChip; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
CONTACT:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
Visit the company profile: http://www.investorideas.com/CO/PSID/
Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.aspVisit the company profile: http://www.investorideas.com/CO/PSID/
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Chairman and CEO of PositiveID (OTCBB: PSID) Discusses Catalysts for 2012 in Diabetes Market and Homeland Security Market
Chairman and CEO of PositiveID (OTCBB: PSID) Discusses Catalysts for 2012 in Diabetes Market and Homeland Security Market
New York, NY- February 16, 2012 – (Investorideas.com Newswire) Medical Technology Stock news alert: Investorideas.com, a leader in research for independent investors presents an exclusive Q&A interview with Medical technology stock, PositiveID Corporation (OTCBB: PSID). Mr. William J. Caragol, Chairman and Chief Executive Officer discusses the catalysts for 2012 for both its diabetes management technologies and its Homeland Security airborne bio-threat detection technology.
Q: Investorideas.com
We noted that late last year the Department of Homeland Security (“DHS”) Office of Health Affairs began the procurement process for the deployment of an autonomous biodetection system called BioWatch Gen-3. Can you give investors insight as to the potential 2012 opportunities for the Company’s airborne bio-threat detection technology (M-BAND) in this process?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
Our MicroFluidic Systems (“MFS”) subsidiary, is a leader in biothreat detection technologies and molecular diagnostic systems, and developed its M-BAND technology under contract from DHS over the past eight years. We believe our M-BAND, a Microfluidics-based Bioagent Autonomous Networked Detector, is one of only two technologies that is compatible with DHS’ procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP. This opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID.
Q: Investorideas.com
With your three diabetes management technologies, Easy Check™, GlucoChip™ and iglucose™, can you give investors a quick summary of some of the recent key developments announced by the Company and some of the key drivers for 2012?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
We continue to make significant progress with each of our diabetes management products. Starting with Easy Check, our non-invasive breath glucose detection device, we completed a prototype device in 2011 and achieved positive preliminary results in early testing that are within industry standards. We recently announced the initiation of a clinical study of Easy Check with Schneider Children’s Medical Center in Israel, led by a world leading endocrinologist. We expect to have results from that study later this year.
Moving on to GlucoChip, a continuous glucose-sensing microchip, we have completed Phase II development and proved a stable and reproducible, closed-cycle continuous glucose sensor that functions in human blood. We also recently provided an update on a biotransport study we are conducting with the Diabetes Research Institute at the University of Miami, which has yielded positive preliminary results. We will continue to provide updates on our progress over the next few months. As those results develop, we will look to work with a partner to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip
Last but not least, we received FDA clearance for iglucose, which is a mobile health system for diabetes management, in late 2011, and are now preparing to roll-out this product with health insurers and home-healthcare providers. As we look ahead to the rest of 2012, we expect that the initial roll-out of iglucose in the first half of the year will be followed by larger orders and partnering agreements.
Q: Investorideas.com
Your technology takes management of diabetes to the clouds literally. With the iglucose technology, the data stored in the diabetes management portal can be shared automatically by text messaging or email. How significant a breakthrough is this for family members, caregivers and healthcare professionals and most importantly, the patient?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
The value proposition of iglucose is to provide an individual with diabetes flexibility and wireless connectivity to better manage their condition and stay in touch with loved ones. With iglucose, an individual no longer has to keep manual logbooks – iglucose automatically pulls the data from a glucometer and sends it to the cloud. Patients can continue to use their preferred blood glucose meter and there is no cell phone or data plan required. iglucose simplifies diabetes management by automating the process of providing blood glucose readings to healthcare professionals for more informed communication and treatment decisions. iglucose also provides peace of mind for family members that their loved ones are testing and what their values are.
Q: Investorideas.com
Easy Check is your non-invasive breath glucose detection device that measures the level of acetone in a patient's exhaled breath and correlates that acetone level to a measure of blood glucose. With a rapid growth of diabetes in children how significant is it to have a technology that could eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
Being able to provide the diabetes community with a non-invasive method of testing their blood sugar is often called the “Holy Grail” of diabetes management. Certainly for children, offering non-invasive testing is even more important and appealing. Many times, people with diabetes do not test as often as prescribed by their physician due to the pain and inconvenience of drawing blood.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that its M-BAND is one of only two technologies that is compatible with DHS’ procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP; the likelihood that this opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID; the likelihood that PositiveID will continue to make significant progress with each of its diabetes management products; the likelihood that PositiveID will have results from its Easy Check clinical study later this year; the likelihood that PositiveID will continue to provide updates on its progress with GlucoChip over the next few months; the likelihood that as those results develop, PositiveID will look to work with a partner to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip; the likelihood that PositiveID is now preparing to roll-out this product with health insurers and home-healthcare providers; the likelihood that the initial roll-out of iglucose in the first half of the year will be followed by larger orders and partnering agreements; the likelihood that iglucose simplifies diabetes management by automating the process of providing blood glucose readings to healthcare professionals for more informed communication and treatment decisions; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully complete development and commercialize Easy Check, GlucoChip and iglucose; the likelihood that PositiveID will participate in BioWatch Gen-3; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
Learn more about PSID at Investorideas.com
http://www.investorideas.com/CO/PSID/
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Contact Investorideas.com 800 665 0411
New York, NY- February 16, 2012 – (Investorideas.com Newswire) Medical Technology Stock news alert: Investorideas.com, a leader in research for independent investors presents an exclusive Q&A interview with Medical technology stock, PositiveID Corporation (OTCBB: PSID). Mr. William J. Caragol, Chairman and Chief Executive Officer discusses the catalysts for 2012 for both its diabetes management technologies and its Homeland Security airborne bio-threat detection technology.
Q: Investorideas.com
We noted that late last year the Department of Homeland Security (“DHS”) Office of Health Affairs began the procurement process for the deployment of an autonomous biodetection system called BioWatch Gen-3. Can you give investors insight as to the potential 2012 opportunities for the Company’s airborne bio-threat detection technology (M-BAND) in this process?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
Our MicroFluidic Systems (“MFS”) subsidiary, is a leader in biothreat detection technologies and molecular diagnostic systems, and developed its M-BAND technology under contract from DHS over the past eight years. We believe our M-BAND, a Microfluidics-based Bioagent Autonomous Networked Detector, is one of only two technologies that is compatible with DHS’ procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP. This opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID.
Q: Investorideas.com
With your three diabetes management technologies, Easy Check™, GlucoChip™ and iglucose™, can you give investors a quick summary of some of the recent key developments announced by the Company and some of the key drivers for 2012?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
We continue to make significant progress with each of our diabetes management products. Starting with Easy Check, our non-invasive breath glucose detection device, we completed a prototype device in 2011 and achieved positive preliminary results in early testing that are within industry standards. We recently announced the initiation of a clinical study of Easy Check with Schneider Children’s Medical Center in Israel, led by a world leading endocrinologist. We expect to have results from that study later this year.
Moving on to GlucoChip, a continuous glucose-sensing microchip, we have completed Phase II development and proved a stable and reproducible, closed-cycle continuous glucose sensor that functions in human blood. We also recently provided an update on a biotransport study we are conducting with the Diabetes Research Institute at the University of Miami, which has yielded positive preliminary results. We will continue to provide updates on our progress over the next few months. As those results develop, we will look to work with a partner to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip
Last but not least, we received FDA clearance for iglucose, which is a mobile health system for diabetes management, in late 2011, and are now preparing to roll-out this product with health insurers and home-healthcare providers. As we look ahead to the rest of 2012, we expect that the initial roll-out of iglucose in the first half of the year will be followed by larger orders and partnering agreements.
Q: Investorideas.com
Your technology takes management of diabetes to the clouds literally. With the iglucose technology, the data stored in the diabetes management portal can be shared automatically by text messaging or email. How significant a breakthrough is this for family members, caregivers and healthcare professionals and most importantly, the patient?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
The value proposition of iglucose is to provide an individual with diabetes flexibility and wireless connectivity to better manage their condition and stay in touch with loved ones. With iglucose, an individual no longer has to keep manual logbooks – iglucose automatically pulls the data from a glucometer and sends it to the cloud. Patients can continue to use their preferred blood glucose meter and there is no cell phone or data plan required. iglucose simplifies diabetes management by automating the process of providing blood glucose readings to healthcare professionals for more informed communication and treatment decisions. iglucose also provides peace of mind for family members that their loved ones are testing and what their values are.
Q: Investorideas.com
Easy Check is your non-invasive breath glucose detection device that measures the level of acetone in a patient's exhaled breath and correlates that acetone level to a measure of blood glucose. With a rapid growth of diabetes in children how significant is it to have a technology that could eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading?
A: Mr. William J. Caragol, Chairman and Chief Executive Officer
Being able to provide the diabetes community with a non-invasive method of testing their blood sugar is often called the “Holy Grail” of diabetes management. Certainly for children, offering non-invasive testing is even more important and appealing. Many times, people with diabetes do not test as often as prescribed by their physician due to the pain and inconvenience of drawing blood.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that its M-BAND is one of only two technologies that is compatible with DHS’ procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP; the likelihood that this opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID; the likelihood that PositiveID will continue to make significant progress with each of its diabetes management products; the likelihood that PositiveID will have results from its Easy Check clinical study later this year; the likelihood that PositiveID will continue to provide updates on its progress with GlucoChip over the next few months; the likelihood that as those results develop, PositiveID will look to work with a partner to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip; the likelihood that PositiveID is now preparing to roll-out this product with health insurers and home-healthcare providers; the likelihood that the initial roll-out of iglucose in the first half of the year will be followed by larger orders and partnering agreements; the likelihood that iglucose simplifies diabetes management by automating the process of providing blood glucose readings to healthcare professionals for more informed communication and treatment decisions; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully complete development and commercialize Easy Check, GlucoChip and iglucose; the likelihood that PositiveID will participate in BioWatch Gen-3; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
Learn more about PSID at Investorideas.com
http://www.investorideas.com/CO/PSID/
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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Disclaimer /Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30, 2012. Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile .More info:www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Contact Investorideas.com 800 665 0411
Thursday, February 9, 2012
Biotech stocks News; BioSante Pharmaceuticals (NasdaqGM: BPAX) Reports Positive LibiGel® Safety Data Review for Phase III Program
LINCOLNSHIRE, Ill. - February 9, 2012 (Investorideas.com Newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.
BioSante reported that with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.53 percent. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33 percent, which is in line with the ages of the subjects enrolled in the study.
"The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased with the low number of CV events to date and we believe it is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante.
Subjects have been enrolled in this study for an average of 19.3 months. More than 2,500 subjects have been enrolled in the study for more than a year and over 830 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.
"BioSante's LibiGel Phase III safety study continues," said Stephen M. Simes, BioSante president & chief executive officer. "We plan to meet with the FDA to determine the best path forward for the program, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year. We have instituted appropriate cost savings in order to minimize the continuing cost of the safety study. Although LibiGel did not meet the co-primary or secondary endpoints in two Phase III efficacy studies, BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including, for example, hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
About LibiGel
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). BioSante continues to analyze the LibiGel data from the two pivotal Phase III efficacy trials first reported on December 14, 2011. These trials were double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. Initial analysis of the efficacy data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences from placebo, results indicated that LibiGel performed as predicted based on previous experience with testosterone products for FSD. Unfortunately, the placebo response in the two efficacy trials was overwhelming; and therefore, LibiGel's results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase I and Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to its products and the LibiGel development program, including in particular the LibiGel safety study and the anticipated timing of BioSante's decision whether to continue the safety study, BioSante's future burn rate and cash runway and other statements identified by words such as "will," "continue," "could," "believes," "intends," "expects," "anticipates," "plans," "may," "potential," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, additional analyses of data from the LibiGel efficacy trials and any other LibiGel clinical trials, including the safety study, may be inconsistent with previously announced results or previously conducted clinical trials or may produce negative or inconclusive results; there may be varying interpretations of data produced by clinical trials; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the success of clinical testing, the success of BioSante's licensees or sublicensees and BioSante's future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante's product development programs, its future burn rate and its need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante's current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other stocks http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure: Investorideas.com is paid by BPAX to publish news and distribute content through Investordeas.com Newswire and its syndicated partners and blogs (six thousand five hundred per three months of publishing)
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
BioSante reported that with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.53 percent. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33 percent, which is in line with the ages of the subjects enrolled in the study.
"The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased with the low number of CV events to date and we believe it is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante.
Subjects have been enrolled in this study for an average of 19.3 months. More than 2,500 subjects have been enrolled in the study for more than a year and over 830 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.
"BioSante's LibiGel Phase III safety study continues," said Stephen M. Simes, BioSante president & chief executive officer. "We plan to meet with the FDA to determine the best path forward for the program, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year. We have instituted appropriate cost savings in order to minimize the continuing cost of the safety study. Although LibiGel did not meet the co-primary or secondary endpoints in two Phase III efficacy studies, BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including, for example, hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
About LibiGel
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). BioSante continues to analyze the LibiGel data from the two pivotal Phase III efficacy trials first reported on December 14, 2011. These trials were double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. Initial analysis of the efficacy data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences from placebo, results indicated that LibiGel performed as predicted based on previous experience with testosterone products for FSD. Unfortunately, the placebo response in the two efficacy trials was overwhelming; and therefore, LibiGel's results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase I and Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to its products and the LibiGel development program, including in particular the LibiGel safety study and the anticipated timing of BioSante's decision whether to continue the safety study, BioSante's future burn rate and cash runway and other statements identified by words such as "will," "continue," "could," "believes," "intends," "expects," "anticipates," "plans," "may," "potential," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, additional analyses of data from the LibiGel efficacy trials and any other LibiGel clinical trials, including the safety study, may be inconsistent with previously announced results or previously conducted clinical trials or may produce negative or inconclusive results; there may be varying interpretations of data produced by clinical trials; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the success of clinical testing, the success of BioSante's licensees or sublicensees and BioSante's future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante's product development programs, its future burn rate and its need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante's current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other stocks http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure: Investorideas.com is paid by BPAX to publish news and distribute content through Investordeas.com Newswire and its syndicated partners and blogs (six thousand five hundred per three months of publishing)
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
More Info:
This news is published on the Investorideas.com Newswire and its syndicated partner network
Wednesday, February 8, 2012
Biotech stocks News; PositiveID Corporation (OTCBB:PSID) Announces Initiation of Clinical Trial of Its Easy Check Non-Invasive Breath Glucose Detection Device
DELRAY BEACH, Fla. - February 7, 2012 (Investorideas.com newswire) - PositiveID Corporation ("PositiveID" or "Company") (OTCBB:PSID), a developer of medical technologies for diabetes management, announced today that it has commenced a clinical trial of its Easy Check(TM) non-invasive breath glucose detection device for people with diabetes. The clinical trial, being held at Schneider Children's Medical Center in Israel, a preeminent research hospital, will initially focus on people with type 1 diabetes and the Company expects to begin recruiting subjects this month.
Currently under development in Israel, Easy Check is a non-invasive breath glucose detection device that measures the level of acetone in a patient's exhaled breath and correlates that acetone level to a measure of blood glucose. The Easy Check technology is based on a patent-pending reagent cell that mixes a patient's exhaled air with a proprietary chemical compound, triggering a chemical reaction. The reaction is measured and software in the Easy Check device then interprets the measurement and correlates the patient's acetone level to the level of glucose in the body. The goal of Easy Check is to eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading.
The purpose of the clinical study is to assess the feasibility of Easy Check compared to a standard invasive blood glucose meter and to assess the reliability of Easy Check in measuring blood glucose levels under conditions of altered blood glucose levels. The study will be led by principal investigator Moshe Phillip, Professor and Director of the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes at Schneider Children's Medical Center of Israel.
Prof. Phillip said, "We are eager to begin testing PositiveID's Easy Check breath device with the hope that one day, Easy Check will offer a non-invasive way to follow the metabolic control of diabetes patients."
PositiveID Chairman and CEO William J. Caragol, said, "After previously announcing positive preliminary laboratory results from testing Easy Check in 2011, this independent clinical study is an important milestone in the advancement of Easy Check. We are very pleased that Prof. Phillip, a world renowned endocrinologist heavily involved in groundbreaking diabetes research, is spearheading this study and we look forward to communicating our progress."
The clinical study has been approved as compliant with the Declaration of Helsinki, which is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
Schneider Children's is the only comprehensive, highly specialized care hospital of its kind in the country of Israel and in the Middle East, dedicated exclusively to the well-being of all children and adolescents. Schneider Children's provides the full range of pediatric subspecialties and comprehensive paramedical services to all children. The medical center serves as the national referral center for Hematology-Oncology, Endocrinology and Childhood Diabetes, and Cardiology and is the country's leading institution in the field of bone marrow and organ transplants, such as heart and lung, liver and kidney.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
The PositiveID Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7717
Statements about PositiveID's future expectations, including the likelihood that the Company will launch the first clinical trial of its Easy Check™ non-invasive breath glucose detection device for people with diabetes later this month; the likelihood that the clinical trial will initially focus on people with type 2 diabetes; the likelihood that Easy Check would eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading; the likelihood that the development of Easy Check continues to progress well as evidenced by the imminent launch of the first clinical trial of this potentially revolutionary product later this month; the likelihood that Easy Check could provide a means for people with diabetes to eliminate the pain associated with taking blood glucose readings, therefore facilitating more frequent testing and improved management of this growing disease; the likelihood that iglucose uses wireless technology to empower individuals with diabetes to be more engaged in the self-management of their condition by eliminating the need to keep manual logbooks; the likelihood that iglucose connects to market leading, data capable glucometers to wirelessly and seamlessly communicate blood glucose readings to the iglucose diabetes management portal, where, with the user's consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize iglucose; the Company's ability to complete development of Easy Check and GlucoChip, as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
CONTACT:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Currently under development in Israel, Easy Check is a non-invasive breath glucose detection device that measures the level of acetone in a patient's exhaled breath and correlates that acetone level to a measure of blood glucose. The Easy Check technology is based on a patent-pending reagent cell that mixes a patient's exhaled air with a proprietary chemical compound, triggering a chemical reaction. The reaction is measured and software in the Easy Check device then interprets the measurement and correlates the patient's acetone level to the level of glucose in the body. The goal of Easy Check is to eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading.
The purpose of the clinical study is to assess the feasibility of Easy Check compared to a standard invasive blood glucose meter and to assess the reliability of Easy Check in measuring blood glucose levels under conditions of altered blood glucose levels. The study will be led by principal investigator Moshe Phillip, Professor and Director of the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes at Schneider Children's Medical Center of Israel.
Prof. Phillip said, "We are eager to begin testing PositiveID's Easy Check breath device with the hope that one day, Easy Check will offer a non-invasive way to follow the metabolic control of diabetes patients."
PositiveID Chairman and CEO William J. Caragol, said, "After previously announcing positive preliminary laboratory results from testing Easy Check in 2011, this independent clinical study is an important milestone in the advancement of Easy Check. We are very pleased that Prof. Phillip, a world renowned endocrinologist heavily involved in groundbreaking diabetes research, is spearheading this study and we look forward to communicating our progress."
The clinical study has been approved as compliant with the Declaration of Helsinki, which is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
Schneider Children's is the only comprehensive, highly specialized care hospital of its kind in the country of Israel and in the Middle East, dedicated exclusively to the well-being of all children and adolescents. Schneider Children's provides the full range of pediatric subspecialties and comprehensive paramedical services to all children. The medical center serves as the national referral center for Hematology-Oncology, Endocrinology and Childhood Diabetes, and Cardiology and is the country's leading institution in the field of bone marrow and organ transplants, such as heart and lung, liver and kidney.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
The PositiveID Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7717
Statements about PositiveID's future expectations, including the likelihood that the Company will launch the first clinical trial of its Easy Check™ non-invasive breath glucose detection device for people with diabetes later this month; the likelihood that the clinical trial will initially focus on people with type 2 diabetes; the likelihood that Easy Check would eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading; the likelihood that the development of Easy Check continues to progress well as evidenced by the imminent launch of the first clinical trial of this potentially revolutionary product later this month; the likelihood that Easy Check could provide a means for people with diabetes to eliminate the pain associated with taking blood glucose readings, therefore facilitating more frequent testing and improved management of this growing disease; the likelihood that iglucose uses wireless technology to empower individuals with diabetes to be more engaged in the self-management of their condition by eliminating the need to keep manual logbooks; the likelihood that iglucose connects to market leading, data capable glucometers to wirelessly and seamlessly communicate blood glucose readings to the iglucose diabetes management portal, where, with the user's consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize iglucose; the Company's ability to complete development of Easy Check and GlucoChip, as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
CONTACT:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
Visit the company profile: http://www.investorideas.com/CO/PSID/
Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.aspVisit the company profile: http://www.investorideas.com/CO/PSID/
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Monday, February 6, 2012
Biotech Stock on the Move: BioSante (NasdaqGM: BPAX) Trades up over 37%
New York, New York – February 6, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for
BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX), trading up at $1.0199, gaining 0.2799(37.82%) 3:10PM EST.
The Company has rebounded from its low of $0.38, now trading above $1.00 with some on the street thinking it can double from here. A follower at Seeking Alpha notes the stock has no real resistance up to $2.01. (http://seekingalpha.com/article/343671-biosante-has-potential-to-double-soon?source=yahoo)
The Company’s last news was a corporate updated issued at the end of January.
http://www.biosantepharma.com/News-Releases.php?ID=013112
.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase I and Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - Source – www.Investorideas.com
BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX), trading up at $1.0199, gaining 0.2799(37.82%) 3:10PM EST.
The Company has rebounded from its low of $0.38, now trading above $1.00 with some on the street thinking it can double from here. A follower at Seeking Alpha notes the stock has no real resistance up to $2.01. (http://seekingalpha.com/article/343671-biosante-has-potential-to-double-soon?source=yahoo)
The Company’s last news was a corporate updated issued at the end of January.
http://www.biosantepharma.com/News-Releases.php?ID=013112
.About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase I and Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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Biotech Stock to Watch: Complete Genomics (Nasdaq:GNOM) Trades up over 15%
New York, New York - February 6, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for Complete Genomics Inc. (Nasdaq:GNOM). The stock is trading up at $3.46, gaining 0.45 (14.95%) 11:03AM EST on over 1.7 Million shares.
About Complete Genomics (Nasdaq:GNOM)
Complete Genomics is the complete human genome sequencing company that has developed and commercialized an innovative DNA sequencing platform. The Complete Genomics Analysis Platform (CGA(TM) Platform) combines Complete Genomics' proprietary human genome sequencing technology with our advanced informatics and data management software. The innovative, end-to-end, outsourced CGA(TM) Service provides customers data ready for genome-based research. Additional information can be found at http://www.completegenomics.com.
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BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
About Complete Genomics (Nasdaq:GNOM)Complete Genomics is the complete human genome sequencing company that has developed and commercialized an innovative DNA sequencing platform. The Complete Genomics Analysis Platform (CGA(TM) Platform) combines Complete Genomics' proprietary human genome sequencing technology with our advanced informatics and data management software. The innovative, end-to-end, outsourced CGA(TM) Service provides customers data ready for genome-based research. Additional information can be found at http://www.completegenomics.com.
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Wednesday, February 1, 2012
Biotech and Pharma Stock Alert; Aethlon Medical (OTC: AEMD) Reports Immediate and Rapid Virologic Responses in Hepatitis C (HCV) Patients Receiving Hemopurifier® Treatment Protocol
SAN DIEGO - February, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, reported today that the administration of Hemopurifier® therapy during the first three days of standard of care peginterferon+ribavirin (PR) drug therapy has demonstrated both immediate and rapid virologic responses in genotype-1 infected HCV patients. An immediate virologic response (IVR) represents a 2-log or 100 fold reduction of HCV RNA at day-7 of therapy and rapid virologic response (RVR) is defined as undetectable HCV RNA at day-30 of the 48-week PR regimen. Average HCV RNA reduction during the three day Hemopurifier® + PR treatment window was 98.79%.
It is estimated that approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S. The Hemopurifier® provides rapid real-time clearance of circulating HCV yielding the potential to improve benefit, dose, duration and tolerability of drug therapies without the introduction of drug toxicity and interaction risks. In previous Hemopurifier® studies, average HCV RNA reductions exceeded 50% during four-hour treatment periods without the administration of drug therapy.
"We are extremely pleased with our interim treatment outcomes, which highlight the synergistic potential of Hemopurifier® and drug therapy working in concert to overcome a disease condition," stated Aethlon Chairman and CEO, Jim Joyce. "In addition to our expansive opportunity in hepatitis C, we continue to advance parallel strategies to address HIV, cancer, and sepsis."
Beyond the opportunity to improve PR standard-of-care therapy, Hemopurifier® therapy may also benefit emerging all-antiviral drug cocktails, which face the challenge of overcoming the rate at which viruses attain drug resistance through rapid mutation. The development of drug-resistant strains can occur quickly owing to the extraordinarily high rate of HCV replication. The clearance of circulating hepatitis C virions, including mutant strains, would inhibit the continued replication of drug-resistant viruses and decrease the likelihood of early onset resistance to emerging all-antiviral strategies.
The Extract-1 Study Protocol
The reported results represent interim data from the first three patients treated with Hemopurifier® therapy under the Extract-1 study protocol, which was initiated in the fall of 2011. The clinical site location previously administered Hemopurifier® therapy to non-genotype 1 HCV patients under various treatment schedules. Under the Extract-1 study protocol, hard-to-treat genotype 1 HCV patients are enrolled to receive three 6-hour applications of Hemopurifier® therapy during the first three days of standard of care PR therapy. On day one of the Extract-1 protocol, PR therapy is initiated within one hour of first Hemopurifer® therapy completion. Hemopurifier® therapy is then administered again once daily for the next two days in combination with PR therapy. During the Hemopurifier® treatment periods, patients are free to watch movies, read books, and perform other tasks in the comfort of a clinic setting.
Clinical Endpoint Assessments
The aim of the Extract-1 study protocol is to assess the safety and clinical impact of intermittent Hemopurifier® therapy when combined with the first three days of peginterferon+ribavirin (PR) standard-of-care. To date, Hemopurifier® therapy in Extract-1 treated patients has been well tolerated and without device-related adverse events during the Hemopurifier® + PR treatment period. At present, the reported data of the Extract-1 study is not statistically significant and should be considered preliminary. Changes in HCV RNA levels are measured with the Roche Cobas TaqMan assay, which has a quantification limit of 15 IU per milliliter (iu/ml). In addition to measuring changes in HCV RNA, the Extract-1 study protocol will quantify the amount of HCV captured within Hemopurifier® treatment cartridges. The goal of PR treatment is to establish a sustained virologic response (SVR), defined as undetectable HCV RNA 24 weeks after completion of therapy. Primary clinical endpoints of the Extract-1 study measure the impact of Hemopurifier® therapy during the initial phase of PR therapy. Each clinical endpoint is based on changes in HCV RNA from baseline viral load measurements taken prior to Hemopurifier® + PR therapy initiation. These endpoints include:
Day Three (3): the change in HCV RNA from baseline to the end of the Hemopurifier® + PR treatment phase;
Day Seven (7): the change in HCV RNA 7 days from initial baseline. A drop of HCV RNA greater than 2 logs at day 7 is known as an Immediate Virologic Response (IVR). Based on the landmark IDEAL Study of 3,070 HCV genotype-1 patients receiving PR therapy, IVR achievement correlates with 90+% SVR rates, yet is observed in less than 5% of patients;
Day 30: the change in HCV RNA 30 days from initial baseline. Undetectable HCV RNA at day 30 is known as a Rapid Virologic Response (RVR). Based on the IDEAL Study, RVR achievement correlates with an SVR likelihood of 86.2%, which is observed in only 10.35% of patients.
Day 3 Results
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured on day 3, representing a 3.49 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 99.96% of the overall HCV RNA reduction reported at day-30.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 31,550 IU/ml when measured on day 3, representing a 0.80 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 84.21% of the overall HCV RNA reduction reported at day-30.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to 54,900 IU/ml when measured on day 3, representing a 1.38 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 95.90% of the overall HCV RNA reduction reported at day-30.
Day 7 Results
On average, the treated patients achieved 2.24 log HCV RNA reduction from baseline at day-7, which is beyond the 2 log reduction that defines the IVR criteria achieved in less than 5% of PR treated patients.
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 234 IU/ml when measured on day 7, representing a 4.39 log reduction.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 17,300 IU/ml when measured on day 7, representing a 1.06 log reduction.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to 24,400 IU/ml when measured on day 7, representing a 1.74 log reduction.
Day 30 Results
Two of the three patients achieved a RVR at day 30, which is normally achieved in only 10.35% of patients receiving PR therapy, yet correlates with a 86.2% SVR versus a 30.4% SVR in patients who fail to achieve a RVR. Based on the IDEAL study, it would normally require the enrollment of approximately 20 PR treated patients to accomplish 2 RVR outcomes. It should also be noted that patient E-1.02 missed RVR achievement by 25 iu/ml.
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to undetectable (<15 IU/ml) when measured on day 30, representing a 5.58 log reduction.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 40 IU/ml when measured on day 30, representing a 3.69 log reduction.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to undetectable (<15 IU/ml) when measured on day 30, representing a 4.95 log reduction.
Beyond high SVR rates, RVR achievement also provides HCV infected individuals the opportunity to reduce PR duration from 48 to 24 weeks (6-month reduction) in RVR patients that maintain undetectable HCV RNA through week 12 of PR therapy. RVR patients are also unlikely to discontinue PR therapy as a result of a non-virological response, which represents the primary reason why 46% of PR therapy patients don't complete their treatment regimen.
RVR achievement also plays a pivotal role in curbing treatment relapse, defined as undetectable HCV RNA at PR completion that again becomes detectable in the 24-week window after therapy completion. As reflected in the IDEAL study, the time to first undetectable HCV RNA correlates with the incidence of treatment relapse. Approximately 50% of patients who achieve complete HCV suppression for the first time by week 24 of therapy suffer from treatment relapse, while less than 10% of RVR patients relapse from therapy.
The Extract-1 study is being conducted at Medanta, The Medicity Institute (Medicity), a $360 million multi-specialty medical institute recently established to be a premier center for medical tourism in India. The principal investigator of the study is Vijay Kher, M.D., Chairman of the Department of Nephrology at the Medanta Kidney & Urology Institute. Dr. Kher previously served as the principal investigator of Hemopurifier® therapy studies conducted at the Apollo and Fortis hospitals in Delhi, India.
Based on the initial Extract-1 study outcomes, Aethlon will seek permission to open up the treatment study to HCV infected individuals who reside outside of India. The company also plans to expand its GMP manufacturing capabilities and upon quantification of HCV capture within Hemopurifier® treatment cartridges, will resubmit an Investigational Device Exemption (IDE) that will request FDA permission to initiate treatment studies in the U.S. The Company is also interested in collaborative clinical opportunities aimed at determining the synergistic effects of Hemopurifier® therapy combined with non-interferon based drug regimens.
About Aethlon Medical
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT� System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT� product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome� to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT� system including the ability to introduce a targeted breast cancer therapy known as HER2osome�, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page on Investorideas.comDisclosure/Disclaimer: AETHLON MEDICAL INC (OTC BB: AEMD) Investorideas.com is paid by AEMD to publish news and distribute content through Investordeas.com Newswire and its syndicated partners and blogs
It is estimated that approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S. The Hemopurifier® provides rapid real-time clearance of circulating HCV yielding the potential to improve benefit, dose, duration and tolerability of drug therapies without the introduction of drug toxicity and interaction risks. In previous Hemopurifier® studies, average HCV RNA reductions exceeded 50% during four-hour treatment periods without the administration of drug therapy."We are extremely pleased with our interim treatment outcomes, which highlight the synergistic potential of Hemopurifier® and drug therapy working in concert to overcome a disease condition," stated Aethlon Chairman and CEO, Jim Joyce. "In addition to our expansive opportunity in hepatitis C, we continue to advance parallel strategies to address HIV, cancer, and sepsis."
Beyond the opportunity to improve PR standard-of-care therapy, Hemopurifier® therapy may also benefit emerging all-antiviral drug cocktails, which face the challenge of overcoming the rate at which viruses attain drug resistance through rapid mutation. The development of drug-resistant strains can occur quickly owing to the extraordinarily high rate of HCV replication. The clearance of circulating hepatitis C virions, including mutant strains, would inhibit the continued replication of drug-resistant viruses and decrease the likelihood of early onset resistance to emerging all-antiviral strategies.
The Extract-1 Study Protocol
The reported results represent interim data from the first three patients treated with Hemopurifier® therapy under the Extract-1 study protocol, which was initiated in the fall of 2011. The clinical site location previously administered Hemopurifier® therapy to non-genotype 1 HCV patients under various treatment schedules. Under the Extract-1 study protocol, hard-to-treat genotype 1 HCV patients are enrolled to receive three 6-hour applications of Hemopurifier® therapy during the first three days of standard of care PR therapy. On day one of the Extract-1 protocol, PR therapy is initiated within one hour of first Hemopurifer® therapy completion. Hemopurifier® therapy is then administered again once daily for the next two days in combination with PR therapy. During the Hemopurifier® treatment periods, patients are free to watch movies, read books, and perform other tasks in the comfort of a clinic setting.
Clinical Endpoint Assessments
The aim of the Extract-1 study protocol is to assess the safety and clinical impact of intermittent Hemopurifier® therapy when combined with the first three days of peginterferon+ribavirin (PR) standard-of-care. To date, Hemopurifier® therapy in Extract-1 treated patients has been well tolerated and without device-related adverse events during the Hemopurifier® + PR treatment period. At present, the reported data of the Extract-1 study is not statistically significant and should be considered preliminary. Changes in HCV RNA levels are measured with the Roche Cobas TaqMan assay, which has a quantification limit of 15 IU per milliliter (iu/ml). In addition to measuring changes in HCV RNA, the Extract-1 study protocol will quantify the amount of HCV captured within Hemopurifier® treatment cartridges. The goal of PR treatment is to establish a sustained virologic response (SVR), defined as undetectable HCV RNA 24 weeks after completion of therapy. Primary clinical endpoints of the Extract-1 study measure the impact of Hemopurifier® therapy during the initial phase of PR therapy. Each clinical endpoint is based on changes in HCV RNA from baseline viral load measurements taken prior to Hemopurifier® + PR therapy initiation. These endpoints include:
Day Three (3): the change in HCV RNA from baseline to the end of the Hemopurifier® + PR treatment phase;
Day Seven (7): the change in HCV RNA 7 days from initial baseline. A drop of HCV RNA greater than 2 logs at day 7 is known as an Immediate Virologic Response (IVR). Based on the landmark IDEAL Study of 3,070 HCV genotype-1 patients receiving PR therapy, IVR achievement correlates with 90+% SVR rates, yet is observed in less than 5% of patients;
Day 30: the change in HCV RNA 30 days from initial baseline. Undetectable HCV RNA at day 30 is known as a Rapid Virologic Response (RVR). Based on the IDEAL Study, RVR achievement correlates with an SVR likelihood of 86.2%, which is observed in only 10.35% of patients.
Day 3 Results
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured on day 3, representing a 3.49 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 99.96% of the overall HCV RNA reduction reported at day-30.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 31,550 IU/ml when measured on day 3, representing a 0.80 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 84.21% of the overall HCV RNA reduction reported at day-30.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to 54,900 IU/ml when measured on day 3, representing a 1.38 log reduction. HCV RNA reduction during the 3-day Hemopurifier® + PR treatment phase accounted for 95.90% of the overall HCV RNA reduction reported at day-30.
Day 7 Results
On average, the treated patients achieved 2.24 log HCV RNA reduction from baseline at day-7, which is beyond the 2 log reduction that defines the IVR criteria achieved in less than 5% of PR treated patients.
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 234 IU/ml when measured on day 7, representing a 4.39 log reduction.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 17,300 IU/ml when measured on day 7, representing a 1.06 log reduction.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to 24,400 IU/ml when measured on day 7, representing a 1.74 log reduction.
Day 30 Results
Two of the three patients achieved a RVR at day 30, which is normally achieved in only 10.35% of patients receiving PR therapy, yet correlates with a 86.2% SVR versus a 30.4% SVR in patients who fail to achieve a RVR. Based on the IDEAL study, it would normally require the enrollment of approximately 20 PR treated patients to accomplish 2 RVR outcomes. It should also be noted that patient E-1.02 missed RVR achievement by 25 iu/ml.
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to undetectable (<15 IU/ml) when measured on day 30, representing a 5.58 log reduction.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 40 IU/ml when measured on day 30, representing a 3.69 log reduction.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to undetectable (<15 IU/ml) when measured on day 30, representing a 4.95 log reduction.
Beyond high SVR rates, RVR achievement also provides HCV infected individuals the opportunity to reduce PR duration from 48 to 24 weeks (6-month reduction) in RVR patients that maintain undetectable HCV RNA through week 12 of PR therapy. RVR patients are also unlikely to discontinue PR therapy as a result of a non-virological response, which represents the primary reason why 46% of PR therapy patients don't complete their treatment regimen.
RVR achievement also plays a pivotal role in curbing treatment relapse, defined as undetectable HCV RNA at PR completion that again becomes detectable in the 24-week window after therapy completion. As reflected in the IDEAL study, the time to first undetectable HCV RNA correlates with the incidence of treatment relapse. Approximately 50% of patients who achieve complete HCV suppression for the first time by week 24 of therapy suffer from treatment relapse, while less than 10% of RVR patients relapse from therapy.
The Extract-1 study is being conducted at Medanta, The Medicity Institute (Medicity), a $360 million multi-specialty medical institute recently established to be a premier center for medical tourism in India. The principal investigator of the study is Vijay Kher, M.D., Chairman of the Department of Nephrology at the Medanta Kidney & Urology Institute. Dr. Kher previously served as the principal investigator of Hemopurifier® therapy studies conducted at the Apollo and Fortis hospitals in Delhi, India.
Based on the initial Extract-1 study outcomes, Aethlon will seek permission to open up the treatment study to HCV infected individuals who reside outside of India. The company also plans to expand its GMP manufacturing capabilities and upon quantification of HCV capture within Hemopurifier® treatment cartridges, will resubmit an Investigational Device Exemption (IDE) that will request FDA permission to initiate treatment studies in the U.S. The Company is also interested in collaborative clinical opportunities aimed at determining the synergistic effects of Hemopurifier® therapy combined with non-interferon based drug regimens.
About Aethlon Medical
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT� System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT� product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome� to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT� system including the ability to introduce a targeted breast cancer therapy known as HER2osome�, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page on Investorideas.comDisclosure/Disclaimer: AETHLON MEDICAL INC (OTC BB: AEMD) Investorideas.com is paid by AEMD to publish news and distribute content through Investordeas.com Newswire and its syndicated partners and blogs
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