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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Thursday, February 16, 2012
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
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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:
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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
Monday, January 30, 2012
Biotech Medical Stock News: PositiveID Corporation (OTCBB:PSID) Obtains Certification from AT&T for iglucose Mobile Health System for Individuals with Diabetes
DELRAY BEACH, FL - January 30, 2012 (Investorideas.com Newswire) Medical Stock Alert; PositiveID Corporation (OTCBB: PSID), a developer of medical technologies for diabetes management, announced today it has obtained certification from AT&T for PositiveID's iglucose™ mobile health system, designed to simplify diabetes management for the millions of individuals impacted by this growing disease. This certification gives PositiveID's FDA-cleared iglucose system access to the AT&T network, which has the largest global presence of any U.S.-based wireless provider.
iglucose is the first and only pocket sized, FDA cleared, mobile health device specifically designed to connect to industry leading glucometers to transmit blood glucose readings anytime, anywhere. By seamlessly communicating glucose readings from a glucometer to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals via text message, email or fax, or through the iglucose diabetes management portal itself. iglucose makes it easier for individuals with diabetes to manage their disease and provides healthcare professionals with better data that can be used to improve clinical insight and treatment decisions.
Laboratory testing for the iglucose device was conducted in AT&T's wireless device testing laboratory. During certification, AT&T subjects each device to a series of rigorous tests to ensure the operational reliability of each unit as well as its ability to function flawlessly across the entire AT&T wireless network. iglucose is specifically designed for mobile monitoring, which helped to ensure optimum performance of the device during testing.
While medical devices for home monitoring have existed for many years, the devices are typically large, expensive and not targeted solely for the diabetes population. iglucose was designed with the end user in mind; the iglucose device fits easily into the pouch individuals with diabetes typically carry containing their blood glucose meter and test strips. Furthermore, because iglucose does not require a phone line or internet connection, its portability and compact size mean it can be used anywhere, anytime.
The iglucose system is compatible with market-leading glucometers such as Johnson & Johnson LifeScan®, Nipro Diagnostic™ True™, Abbott Freestyle®, and Bayer Breeze® and Contour® meters.
PositiveID Chairman and CEO William J. Caragol, said, "AT&T certification, which is not easily achieved, is an important confirmation of the performance and dependability of iglucose . As we continue to prepare to roll-out this mobile health system early this year through pilot programs with insurers and home-healthcare providers, AT&T certification provides us significant validation upon which our customers and partners can rely."
More than 25 million children and adults in the U.S. have diabetes, or over eight 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 http://www.PositiveIDCorp.com .
For more information on iglucose, please visit http://www.iglucose.com . For sales and partnership opportunities, please contact Mary Ellen Harrison at 561-805-8028 or meharrison@positiveidcorp.com.
Statements about PositiveID's future expectations, including the likelihood that AT&T certification gives PositiveID's FDA-cleared iglucose system access to the AT&T network, which has the largest global presence of any U.S.-based wireless provider; the likelihood that iglucose makes it easier for individuals with diabetes to manage their disease and provides healthcare professionals with better data that can be used to improve clinical insight and treatment decisions; the likelihood that because iglucose does not require a phone line or internet connection, its portability and compact size mean it can be used anywhere, anytime; the likelihood the iglucose system is compatible with market-leading glucometers such as Johnson & Johnson LifeScan, Nipro Diagnostic True, Abbott Freestyle, and Bayer Breeze and Contour meters; the likelihood that AT&T certification, which is not easily achieved, is an important confirmation of the performance and dependability of iglucose; the likelihood that as PositiveID continues to prepare to roll-out this mobile health system early this year through pilot programs with insurers and home-healthcare providers, AT&T certification provides PositiveID significant validation upon which its customers and partners can rely; 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, 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
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
iglucose is the first and only pocket sized, FDA cleared, mobile health device specifically designed to connect to industry leading glucometers to transmit blood glucose readings anytime, anywhere. By seamlessly communicating glucose readings from a glucometer to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals via text message, email or fax, or through the iglucose diabetes management portal itself. iglucose makes it easier for individuals with diabetes to manage their disease and provides healthcare professionals with better data that can be used to improve clinical insight and treatment decisions.
Laboratory testing for the iglucose device was conducted in AT&T's wireless device testing laboratory. During certification, AT&T subjects each device to a series of rigorous tests to ensure the operational reliability of each unit as well as its ability to function flawlessly across the entire AT&T wireless network. iglucose is specifically designed for mobile monitoring, which helped to ensure optimum performance of the device during testing.
While medical devices for home monitoring have existed for many years, the devices are typically large, expensive and not targeted solely for the diabetes population. iglucose was designed with the end user in mind; the iglucose device fits easily into the pouch individuals with diabetes typically carry containing their blood glucose meter and test strips. Furthermore, because iglucose does not require a phone line or internet connection, its portability and compact size mean it can be used anywhere, anytime.
The iglucose system is compatible with market-leading glucometers such as Johnson & Johnson LifeScan®, Nipro Diagnostic™ True™, Abbott Freestyle®, and Bayer Breeze® and Contour® meters.
PositiveID Chairman and CEO William J. Caragol, said, "AT&T certification, which is not easily achieved, is an important confirmation of the performance and dependability of iglucose . As we continue to prepare to roll-out this mobile health system early this year through pilot programs with insurers and home-healthcare providers, AT&T certification provides us significant validation upon which our customers and partners can rely."
More than 25 million children and adults in the U.S. have diabetes, or over eight 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 http://www.PositiveIDCorp.com .
For more information on iglucose, please visit http://www.iglucose.com . For sales and partnership opportunities, please contact Mary Ellen Harrison at 561-805-8028 or meharrison@positiveidcorp.com.
Statements about PositiveID's future expectations, including the likelihood that AT&T certification gives PositiveID's FDA-cleared iglucose system access to the AT&T network, which has the largest global presence of any U.S.-based wireless provider; the likelihood that iglucose makes it easier for individuals with diabetes to manage their disease and provides healthcare professionals with better data that can be used to improve clinical insight and treatment decisions; the likelihood that because iglucose does not require a phone line or internet connection, its portability and compact size mean it can be used anywhere, anytime; the likelihood the iglucose system is compatible with market-leading glucometers such as Johnson & Johnson LifeScan, Nipro Diagnostic True, Abbott Freestyle, and Bayer Breeze and Contour meters; the likelihood that AT&T certification, which is not easily achieved, is an important confirmation of the performance and dependability of iglucose; the likelihood that as PositiveID continues to prepare to roll-out this mobile health system early this year through pilot programs with insurers and home-healthcare providers, AT&T certification provides PositiveID significant validation upon which its customers and partners can rely; 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, 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
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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