Water Stocks, Natural Gas Stocks and Renewable Energy Stocks Lead Sectors
POINT ROBERTS, October 18 , 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors, reports on this weeks trending top ten investor searches.
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX ) was the most searched by investors in the past week following news from the Company that the independent Data Monitoring Committee (DMC) had completed the seventh 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, for which there is no FDA-approved product.
Leading sectors searched by investors included water stocks, natural gas stocks and renewable energy stocks.
Investorideas.com Top Investor Searches…
1. NASDAQ:BPAX
2. NASDAQ:HEV
3. NASDAQ:AONE
4. NASDAQ:SZYM
5. NASDAQ:TSLA
6. Water Stocks
7. NASDAQ:SINA
8. NASDAQ:TQNT
9. Natural Gas Stocks
10. Renewable Energy Stocks
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Tuesday, October 18, 2011
Biotech Stock News; Aethlon Medical (OTCBB: AEMD) Announces Availability of its Exosome Detection Assay to the Research Community
SAN DIEGO � October 18, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that it will begin accepting orders for its Enzyme Linked Lectin Specific Assay (ELLSA™) from researchers that require a highly sensitive diagnostic tool to detect the presence of exosomes in cell culture, ascites, and other biological fluids, including blood.
"We are going to produce ELLSA™ on a limited basis to satisfy the organic demand for our technology, which is primarily being driven by researchers who participated in a beta-testing program," stated Aethlon CEO, Jim Joyce. "However, as our focus is directed toward advancing Aethlon ADAPT™ system therapies, we plan to license or sell ELLSA™ to an organization that is already established in the research diagnostics field." Each ELLSA™ plate allows for up to 96 exosome detection tests. Further analysis of the captured exosomes is possible through detection molecules such as antibodies linked to a specific biomarker on the exosome. ELLSA™ has demonstrated the ability to identify and quantify the presence of exosomes produced by human immunodeficiency virus (HIV), and tuberculosis (TB), as well as all forms of cancer tested to date. The introductory price for each ELLSA order placed by November 30, 2011 is $179.00 per kit. To place an order, contact Paul Duffin at 858-459-7800 x306, or by email at paul@aethlonmedical.com. Aethlon Medical is offering ELLSA™ for research purposes only and not for human use.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. 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 to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its 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, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.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
"We are going to produce ELLSA™ on a limited basis to satisfy the organic demand for our technology, which is primarily being driven by researchers who participated in a beta-testing program," stated Aethlon CEO, Jim Joyce. "However, as our focus is directed toward advancing Aethlon ADAPT™ system therapies, we plan to license or sell ELLSA™ to an organization that is already established in the research diagnostics field." Each ELLSA™ plate allows for up to 96 exosome detection tests. Further analysis of the captured exosomes is possible through detection molecules such as antibodies linked to a specific biomarker on the exosome. ELLSA™ has demonstrated the ability to identify and quantify the presence of exosomes produced by human immunodeficiency virus (HIV), and tuberculosis (TB), as well as all forms of cancer tested to date. The introductory price for each ELLSA order placed by November 30, 2011 is $179.00 per kit. To place an order, contact Paul Duffin at 858-459-7800 x306, or by email at paul@aethlonmedical.com. Aethlon Medical is offering ELLSA™ for research purposes only and not for human use.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. 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 to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its 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, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.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
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com
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Monday, October 17, 2011
Biotech Leads Friday's NASDAQ Winners: GTXI, ACHN, SZYM, GNOM;
POINT ROBERTS - October 17, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors, reports on top percentage gainers on the NASDAQ for Friday October 14th. Nasdaq closed higher by +47.61 (+1.82%) at 2667.85.
GTx, Inc. (NASDAQ:GTXI) was the top percentage gainer for the session closing higher 0.68 (20.36%) to $4.02 after analyst at Rodman & Renshaw started coverage on the stock an "outperform" rating and a $7.00 price target on the stock.
The stock is continuing its gains in early morning trading Monday.
The Company is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways for the treatment of cancer, cancer supportive care, and other serious medical conditions.
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) surged 0.89 (18.05%) to close at $5.82 after it announced the nomination of an additional clinical candidate for the treatment of the hepatitis C virus (HCV) from its NS5A inhibitor program. The candidate, ACH-3102, is a second generation NS5A inhibitor that in preclinical studies has demonstrated potent pan-genotypic activity against HCV genotypes 1 - 6, including excellent activity against both the genotype 1a subtype and known mutant variants of genotype 1 HCV.
Solazyme Inc (NASDAQ:SZYM) closed with an impressive gain of 1.50 (17.99%) to end the day at $9.84, bouncing back from its recent low. The stock has a 52-week range of $7.68-$27.47. The company has market capitalization of $587.15 million.
Complete Genomics, Inc. (NASDAQ:GNOM) moved higher by 0.78 (16.53%) to $5.50, bouncing back from its 52-week low made on Oct 13, 2011. The stock has a 52-week range of $4.70-$18.55. The company has market capitalization of $181.99 million.
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GTx, Inc. (NASDAQ:GTXI) was the top percentage gainer for the session closing higher 0.68 (20.36%) to $4.02 after analyst at Rodman & Renshaw started coverage on the stock an "outperform" rating and a $7.00 price target on the stock.
The stock is continuing its gains in early morning trading Monday.
The Company is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways for the treatment of cancer, cancer supportive care, and other serious medical conditions.
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) surged 0.89 (18.05%) to close at $5.82 after it announced the nomination of an additional clinical candidate for the treatment of the hepatitis C virus (HCV) from its NS5A inhibitor program. The candidate, ACH-3102, is a second generation NS5A inhibitor that in preclinical studies has demonstrated potent pan-genotypic activity against HCV genotypes 1 - 6, including excellent activity against both the genotype 1a subtype and known mutant variants of genotype 1 HCV.
Solazyme Inc (NASDAQ:SZYM) closed with an impressive gain of 1.50 (17.99%) to end the day at $9.84, bouncing back from its recent low. The stock has a 52-week range of $7.68-$27.47. The company has market capitalization of $587.15 million.
Complete Genomics, Inc. (NASDAQ:GNOM) moved higher by 0.78 (16.53%) to $5.50, bouncing back from its 52-week low made on Oct 13, 2011. The stock has a 52-week range of $4.70-$18.55. The company has market capitalization of $181.99 million.
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Biotech and Pharma stocks News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at BioCentury and BIO Healthcare Conferences
LINCOLNSHIRE, Ill. - October 17, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that Stephen M. Simes, BioSante�s president & CEO will present at two healthcare conferences in October. Mr. Simes will speak at the BioCentury NewsMakers in the Biotech Industry on Friday, October 21 at 11:30 am EDT in New York and at the BIO Investor Forum on Tuesday, October 25 at 3:30 pm PDT in San Francisco.
BioSante will provide a company overview at each conference, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program and planned new drug application (NDA) submission.
A live audio webcast of remarks by Mr. Simes, at the BioCentury conference may be accessed at http://www.corporate-ir.net/ireye/ conflobby.zhtml?ticker= BPAX&item_id=4209619. A live audio webcast of remarks by Mr. Simes, at BIO Investor Forum may be accessed at http://www.veracast.com/webcasts/ bio/ investorforum2011/16113461.cfm. Both webcasts will be archived for 90 days.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Contact:
BioSante Pharmaceuticals
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 showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) 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.
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 will provide a company overview at each conference, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program and planned new drug application (NDA) submission.
A live audio webcast of remarks by Mr. Simes, at the BioCentury conference may be accessed at http://www.corporate-ir.net/ireye/ conflobby.zhtml?ticker= BPAX&item_id=4209619. A live audio webcast of remarks by Mr. Simes, at BIO Investor Forum may be accessed at http://www.veracast.com/webcasts/ bio/ investorforum2011/16113461.cfm. Both webcasts will be archived for 90 days.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Contact:
BioSante Pharmaceuticals
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 showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) 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.
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
Friday, October 14, 2011
Investors Seeing the Upside in BioSante Pharmaceuticals (NasdaqGM: BPAX) Following News of LibiGel® Positive Data
Point Roberts, WA - October 14, 2011- Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for specialty pharmaceutical company, BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX). The stock closed Thursday at $2.4, up 0.13 (5.56%) on just over 1 Million shares.
The stock has a 52-week high of $4.02 and has analysts confident with a 12 -month price target price of $5.00.
The Company reported news this week of positive LibiGel® safety data review in the Phase III program. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no current FDA-approved product.
The LibiGel® l NDA is currently targeted for the end of 2012. Rodman & Renshaw's analyst covering the stock, Elemer Piros, predicts sales of $500 million annually by 2021.
The Company stated in its release this week, "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 that the low number of CV events to date 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. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."
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 study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
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 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.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal 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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under 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.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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 future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as "anticipates," "expects," "will," "continue," "could," "believes," "intends," "estimates," "may," 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
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 (NasdaqGM: BPAX) is a featured Biotech/Pharma stock on Investorideas.com
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800-665-0411
The stock has a 52-week high of $4.02 and has analysts confident with a 12 -month price target price of $5.00.
The Company reported news this week of positive LibiGel® safety data review in the Phase III program. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no current FDA-approved product.
The LibiGel® l NDA is currently targeted for the end of 2012. Rodman & Renshaw's analyst covering the stock, Elemer Piros, predicts sales of $500 million annually by 2021.
The Company stated in its release this week, "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 that the low number of CV events to date 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. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety StudyThe 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 study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
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 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.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal 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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under 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.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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 future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as "anticipates," "expects," "will," "continue," "could," "believes," "intends," "estimates," "may," 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
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 (NasdaqGM: BPAX) is a featured Biotech/Pharma stock on Investorideas.com
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sectors. Sectors we cover include; water stocks, gold and mining stocks, China stocks, oil and gas stocks, renewable energy stocks, coal stocks, tech stocks, biotech stocks, defense stocks, nanotech, agriculture and gaming.
Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
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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. BioSante is a paid advertising biotech stock on Investorideas.com (six thousand five hundred for three months)
Source - Investorideas.com
800-665-0411
Tuesday, October 11, 2011
Biotech/Pharma stocks News; BioSante Pharmaceuticals (NASDAQ: BPAX) Reports Positive LibiGel® Safety Data Review in Phase III Program
LINCOLNSHIRE, Ill. - October 11, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), announced today that the independent Data Monitoring Committee (DMC) has completed the seventh 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, for which there is no FDA-approved product.
BioSante reported that with 3,656 women enrolled and over 4,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 29 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.60 percent. In the same population of subjects, there have been 17 breast cancers reported, a rate of approximately 0.35 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 that the low number of CV events to date 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. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."
Subjects have been enrolled in this study for an average of 15.7 months. More than 2,000 subjects have been enrolled in the study for more than a year and over 770 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.
"LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD," said Stephen M. Simes, BioSante�s president & CEO. "With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, also referred to as FSD, in menopausal women."
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 study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
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 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.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal 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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under 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.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the UnitedStates
, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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 future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as "anticipates," "expects," "will," "continue," "could," "believes," "intends," "estimates," "may," 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
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 showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) 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.
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 4,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 29 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.60 percent. In the same population of subjects, there have been 17 breast cancers reported, a rate of approximately 0.35 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 that the low number of CV events to date 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. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."
Subjects have been enrolled in this study for an average of 15.7 months. More than 2,000 subjects have been enrolled in the study for more than a year and over 770 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.
"LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD," said Stephen M. Simes, BioSante�s president & CEO. "With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, also referred to as FSD, in menopausal women."
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 study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
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 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.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal 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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under 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.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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 future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as "anticipates," "expects," "will," "continue," "could," "believes," "intends," "estimates," "may," 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
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 showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) 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.
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
Wednesday, October 5, 2011
Biotech and Pharma News; Aethlon (OTCBB: AEMD) Announces Hemopurifier® and HER2osome™ Cancer Therapy Presentation
SAN DIEGO � October 5, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the Aethlon Hemopurifier® and HER2osome™ cancer therapy will be the subject of a presentation at the Exosomes and Microvesicles 2011 conference on October 17th. The event is being held at the Wyndham Lake Buena Vista Resort located in Walt Disney World, Florida. Dr. Annette Marleau, Director of Tumor Immunology at Aethlon Medical will give the presentation. Both the Aethlon Hemopurifier® and HER2osome™ represent novel exosome-targeted strategies to improve cancer treatment outcomes. Exosomes released by cancers have recently emerged to become therapeutic targets in cancer care, as they are implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes assist tumors in evading the response of the immune system.
About HER2osome™
HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. HER2osome™ is a novel medical device, whose goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer. Research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin® (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to fill an unmet medical need and enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks.
About the Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both HCV and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study in India to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy. An investigational device exemption (IDE) to initiate clinical studies in the United States is pending with The Food and Drug Administration (FDA).
In vitro studies have also documented that the Hemopurifier® captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. Aethlon recently expanded its exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, California. The SOC collaboration is studying the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma.
To support the advancement of its therapeutic candidates, Aethlon has developed a diagnostic assay known as ELLSA™ that is able to identify and quantify the presence of exosomes in blood and other fluids. Aethlon plans to license or sell this technology to an organization already established in the research diagnostics field.
The Aethlon Hemopurifier® and HER2osome™ were both developed from the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology that provides the foundation for a new class of therapeutics that selectively target the clearance of harmful agents from the entire circulatory system without the loss of essential blood components. Therapies that evolve from the Aethlon ADAPT™ system overcome the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, the device platform allows the immobilization of single or multiple affinity drug agents in the outer-capillary space of plasma membrane technology as a means to provide rapid real-time clearance of corresponding targets without adding drug toxicity or interaction risks to established therapies. Beyond providing a novel regulatory and commercialization pathway for affinity drug agents, Aethlon ADAPT™ therapies can be implemented for use within the global infrastructure of dialysis machines and CRRT systems already located in hospitals and clinics. As Aethlon advances its current pipeline of therapies toward market, the company will market the ADAPT™ system to government agencies and organizations representing the pharmaceutical, biotechnology and medical device industry. On September 30, 2011, Aethlon was awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device from the ADAPT™ system that would reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. 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 to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its 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, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.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
About HER2osome™
HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. HER2osome™ is a novel medical device, whose goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer. Research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin® (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to fill an unmet medical need and enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks.
About the Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both HCV and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study in India to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy. An investigational device exemption (IDE) to initiate clinical studies in the United States is pending with The Food and Drug Administration (FDA).
In vitro studies have also documented that the Hemopurifier® captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. Aethlon recently expanded its exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, California. The SOC collaboration is studying the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma.
To support the advancement of its therapeutic candidates, Aethlon has developed a diagnostic assay known as ELLSA™ that is able to identify and quantify the presence of exosomes in blood and other fluids. Aethlon plans to license or sell this technology to an organization already established in the research diagnostics field.
The Aethlon Hemopurifier® and HER2osome™ were both developed from the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology that provides the foundation for a new class of therapeutics that selectively target the clearance of harmful agents from the entire circulatory system without the loss of essential blood components. Therapies that evolve from the Aethlon ADAPT™ system overcome the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, the device platform allows the immobilization of single or multiple affinity drug agents in the outer-capillary space of plasma membrane technology as a means to provide rapid real-time clearance of corresponding targets without adding drug toxicity or interaction risks to established therapies. Beyond providing a novel regulatory and commercialization pathway for affinity drug agents, Aethlon ADAPT™ therapies can be implemented for use within the global infrastructure of dialysis machines and CRRT systems already located in hospitals and clinics. As Aethlon advances its current pipeline of therapies toward market, the company will market the ADAPT™ system to government agencies and organizations representing the pharmaceutical, biotechnology and medical device industry. On September 30, 2011, Aethlon was awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device from the ADAPT™ system that would reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. 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 to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its 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, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.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
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