Point Roberts WA, LINCOLNSHIRE, Ill. May 3, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive discussion with Mr. Stephen M. Simes, president and chief executive officer of specialty pharmaceutical company, BioSante Pharmaceuticals ( NASDAQ: BPAX ) . Mr. Simes discusses how their product LibiGel ®, (testosterone gel) for the treatment of female sexual dysfunction, paves the way for women's equality in the sexual dysfunction market, currently dominated by male products.
Women always have had to wait for their rights; from the right to vote, to equal pay and now in the treatment of sexual health matters. Stephen M. Simes discusses his personal and corporate commitment to women's health, and BioSante's objective to be first to market with a pharmaceutical product to treat women's sexual health.
In an interesting perspective from a male CEO bringing his product to market for women, Mr. Simes passionately explains the problem and the solution (LibiGel ®) that is coming to market in the not so distant future. Interestingly, BioSante's vice president of clinical development in charge of LibiGel's clinical studies is a woman!
Sexual Equality for Women!
Why is there no biotech or pharmaceutical product for the treatment of female sexual dysfunction?
By Stephen M. Simes
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
Men have enjoyed access to Viagra and other erectile drugs for over 13 years.
For women, specifically women suffering from hypoactive sexual desire disorder (HSDD), product development has been notably lacking. Today in the United States there is no FDA approved pharmaceutical product for the treatment of HSDD.
Yet HSDD - lack of sexual desire - affects an untold number of women. It is more common than erectile dysfunction in men - which is a $2 billion a year prescription business in the US.
In a study by investigators the University of Chicago, of 1,400 men and 1,700 women between the ages of 18 and 59, 43% of women said they have experienced some degree of sexual dysfunction, compared with just 31% of men. Among the women surveyed, 32% lacked interest in sex. Another study by the same group at the University also found that 43% of American women between the ages of 57 and 85 (about 40 million) experience some degree of low sexual desire.
The majority of women with female sexual dysfunction (FSD) are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
Today, there is only one company in the world in active clinical development of a product for this true unmet medical need in women. The company in development of a product is BioSante Pharmaceuticals Inc., in Lincolnshire, Illinois. The product is a transdermal testosterone gel (LibiGel ®). LibiGel currently is in Phase III clinical studies for the treatment of HSDD in post-menopausal women. The LibiGel Phase III clinical development program includes two traditional pivotal Phase III randomized, placebo-controlled, multi-center, safety and efficacy trials, both of which are covered by an FDA SPA (special protocol assessment).
In addition, BioSante is conducting a LibiGel Phase III randomized, placebo controlled, multi-center, cardiovascular event and breast cancer safety study. Over 3,000 of a potential 4,000 women have been enrolled in the study and randomized to LibiGel or placebo. This LibiGel safety study represents the largest database of the safety of testosterone in women ever. To date, the cardiovascular event and breast cancer event rates in the study are lower than predicted. BioSante plans on submitting a new drug application (NDA) to FDA seeking approval for LibiGel by the end of 2012.
LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
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.
BioSante is committed to the success of LibiGel and to women's health. The time for equal treatment of men's and women's sexuality is here. Practitioners and women are waiting for solutions.
- Stephen M. Simes is president and CEO of BioSante Pharmaceuticals Inc. (http://www.biosantepharma.com), Lincolnshire, IL.
About BioSante Pharmaceuticals, Inc.
BioSante (NASDAQ: BPAX) 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'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 II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up page: http://www.investorideas.com/Resources/Newsletter.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (two thousand per month) 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, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 future operations and products and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or 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 Investorideas.com:
C Van Zant: 800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com, BioSante
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Tuesday, May 3, 2011
Thursday, April 28, 2011
Q&A With Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Discussing BioSante's Pipeline into 2012
Point Roberts WA, LINCOLNSHIRE, Ill. April 28, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of specialty pharmaceutical company, BioSante Pharmaceuticals. Mr Simes discusses the current product line of LibiGel�, Bio-T-Gel� and Elestrin� into 2012.
Postured to be the first-to-market with an FDA approved product for the treatment of female sexual dysfunction with LibiGel ®, Mr. Simes lays out the roadmap as the company heads into 2012.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, can you give investors an overview of your first FDA-approved product Elestrin™?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Elestrin is FDA-approved for the treatment of hot flashes in menopausal women, an over $1.5 billion market in the U.S. alone. Significantly, the product development team at BioSante developed Elestrin from just a product formulation through clinical trials, a new drug application submitted to the FDA, and a full non-conditional FDA-approval. It is this same BioSante team that is working on our much bigger potential product, LibiGel.
Q: Investorideas.com
Your leading product, LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) currently in Phase III clinical development, will bring BioSante to market first in this category - can you give us insight as to the significance of what this represents?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
LibiGel is the only product in the world in clinical development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder, for which there is no FDA-Approved product, a full 13 years after Viagra was approved for men. It is time that women had a choice for treatment of their sexual health. We believe LibiGel will be the first product to be FDA-approved for this exciting indication, estimated to be a multi-billion market. Importantly, there were 4 million testosterone prescriptions written off-label for women in the U.S. in 2009. Physicians surveyed commented that they will switch 96% of their patients over to the FDA-approved, precise metered dose alternative when it becomes available.
Q: Investorideas.com
Bio-T-Gel™, a testosterone gel for male hypogonadism, has a pending NDA; can you give us a brief overview of the status and predicted timelines for this product?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Bio-T-Gel is our male testosterone product already licensed to TEVA (NASDAQ: TEVA) for marketing in the U.S. The current market for male testosterone products in the U.S. is over $1.2 billion and growing. TEVA is a dynamic sales and marketing company and we are confident they can capture a significant share of market. BioSante will be paid a royalty on TEVA sales of Bio-T-Gel. The FDA's assigned target (PDUFA date) to complete their review of the Bio-T-Gel NDA is November 14, 2011. Therefore, Bio-T-Gel could be launched late this year or early next.
Q: Investorideas.com
Can you give investors a brief overview of the company's financial status?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
At March 31, 2011, we had approximately $51.3 million in cash. This cash balance is sufficient to take us well into 2012 without any need to raise additional capital. We believe we have removed the financing risk from BioSante for the foreseeable future.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) 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'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 II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA has been filed with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up page: http://www.investorideas.com/Resources/Newsletter.asp
Recent Research; JMP Securities
Full report: http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (one thousand per month) 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, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 future operations and products and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or 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 Investorideas.com:
C Van Zant: 800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com, BioSante
Postured to be the first-to-market with an FDA approved product for the treatment of female sexual dysfunction with LibiGel ®, Mr. Simes lays out the roadmap as the company heads into 2012.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, can you give investors an overview of your first FDA-approved product Elestrin™?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Elestrin is FDA-approved for the treatment of hot flashes in menopausal women, an over $1.5 billion market in the U.S. alone. Significantly, the product development team at BioSante developed Elestrin from just a product formulation through clinical trials, a new drug application submitted to the FDA, and a full non-conditional FDA-approval. It is this same BioSante team that is working on our much bigger potential product, LibiGel.
Q: Investorideas.com
Your leading product, LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) currently in Phase III clinical development, will bring BioSante to market first in this category - can you give us insight as to the significance of what this represents?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
LibiGel is the only product in the world in clinical development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder, for which there is no FDA-Approved product, a full 13 years after Viagra was approved for men. It is time that women had a choice for treatment of their sexual health. We believe LibiGel will be the first product to be FDA-approved for this exciting indication, estimated to be a multi-billion market. Importantly, there were 4 million testosterone prescriptions written off-label for women in the U.S. in 2009. Physicians surveyed commented that they will switch 96% of their patients over to the FDA-approved, precise metered dose alternative when it becomes available.
Q: Investorideas.com
Bio-T-Gel™, a testosterone gel for male hypogonadism, has a pending NDA; can you give us a brief overview of the status and predicted timelines for this product?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Bio-T-Gel is our male testosterone product already licensed to TEVA (NASDAQ: TEVA) for marketing in the U.S. The current market for male testosterone products in the U.S. is over $1.2 billion and growing. TEVA is a dynamic sales and marketing company and we are confident they can capture a significant share of market. BioSante will be paid a royalty on TEVA sales of Bio-T-Gel. The FDA's assigned target (PDUFA date) to complete their review of the Bio-T-Gel NDA is November 14, 2011. Therefore, Bio-T-Gel could be launched late this year or early next.
Q: Investorideas.com
Can you give investors a brief overview of the company's financial status?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
At March 31, 2011, we had approximately $51.3 million in cash. This cash balance is sufficient to take us well into 2012 without any need to raise additional capital. We believe we have removed the financing risk from BioSante for the foreseeable future.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) 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'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 II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA has been filed with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up page: http://www.investorideas.com/Resources/Newsletter.asp
Recent Research; JMP Securities
Full report: http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (one thousand per month) 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, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 future operations and products and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or 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 Investorideas.com:
C Van Zant: 800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com, BioSante
Wednesday, April 27, 2011
Biotech /Pharma Stocks Snapshot; Technology and Medical Devices on the Rise Within Healthcare; Aethlon Medical (OTCBB: AEMD), ELI Lilly (LLY) Medtronic (MDT), Pfizer (PFE), (Apple (AAPL)
Point Roberts, WA- April 27, 2011-Investorideas.com, a leader in sector stock research including
biotech/pharma stocks, reports on new trends in the healthcare sector where the industry is
reporting that medical technology is on the rise, and the development of new drugs may be
slowing down. The cost to bring a new drug to market, and the success rates may be a factor
in why some of the leading companies are looking at advancement in medical technology and
devices.
“In our case, we are leveraging our Hemopurifier® device to provide therapeutic capabilities
that target to improve infectious disease and cancer drug therapies,” stated Jim Joyce, CEO of
Aethlon Medical (OTCBB: AEMD).
Partnering technology to advance delivery of drugs is also a key to the future of healthcare. Eli
Lilly and Company (NYSE:LLY) and Medtronic, Inc. (NYSE:MDT) recently announced they have
entered into a collaboration to research and develop a new approach to treating Parkinson's
disease that involves delivering a potential new medicine to the brain using an implantable
drug delivery system. The goal of the collaboration is to develop a therapeutic approach for
Parkinson's disease that combines the strengths of Lilly's biologic, a modified form of glial
cell derived neurotrophic factor (GDNF), with Medtronic's implantable drug infusion system
technology.
As technology plays a key role in healthcare , new players enter the market from within the tech
sector including Apple’s (NasdaqGS: AAPL ) iPad, predicted to potentially revolutionize the
health-care universe.
Sector Snapshot
Aethlon Medical (OTCBB: AEMD) trading at $ 0.0911 - 0.10
Apple Inc.(NasdaqGS: AAPL ) trading at $348.69, down 1.73 (0.49%) 11:40AM EDT
Eli Lilly and Company (NYSE: LLY ) trading up at$ 37.10, up 0.28 (0.76%) 11:41AM EDT
Medtronic Inc.(NYSE: MDT ) trading at $41.38, up 0.14 (0.34%) 11:42AM EDT
Pfizer, Inc. Common Stock(NYSE: PFE ) trading at $20.44, up 0.25 (1.24%) 11:43AM EDT
Market Snapshot
Dow 12,609.68 +14.31 +0.11%
Nasdaq 2,847.00 -0.54 -0.02%
S&P 500 1,346.08 -1.16 -0.09%
10 Yr Bond(%) 3.3680% +0.0480
Oil 112.04 -0.17 -0.15%
Gold 1,508.50 +1.50 +0.10%
Recent article; Are Medical Devices the New Drugs? QMed.com
Published: April 20, 2011
w.qmed.com/mpmn/blog/44335/are-medical-devices-new-drugs
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase profile at Investorideas.com
http://www.investorideas.com/CO/AEMD/
Recent News:
About the Company:
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer.
Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in
disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious
viruses and immunosuppressive proteins from the entire circulatory system. We recently
discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune
system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly
inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer
care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need
and provide the benefit of an immune-based therapy without adding drug toxicity or interaction
risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load
in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients
without the administration of antiviral drugs. However, our initial clinical and commercialization
focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both
infectious disease and cancer treatment regimens. In this regard, we plan to commercialize
our Hemopurifier® in India as we advance our clinical strategies in the United States and the
European Union. In vitro studies conducted by government and non-government research
institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against
bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue
Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1
Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus,
and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market
opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer
therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of
standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected
individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to
address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism
of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery
solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed
for implementation within the established infrastructure of dialysis machines and other blood
circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that
tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer
and glycoproteins residing on the envelope of viruses. These agents are immobilized around
approximately 2800 porous hollow fibers that run the interior length of our device. The resulting
design provides us the novel ability to separate both exosome and viral targets away from blood
cells so they can then be selectively and permanently removed from the circulatory system. In
application, blood circulation is established into the Hemopurifier® via a catheter or other blood
access device. Once blood flow has been established, treatment benefit is immediate as the
entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of
exosome-targeted products and services that improve cancer diagnosis, provide post-treatment
cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient
therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be
accessed online at 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 company's ability to commercialize its Hemopurifier® in India, capability of
the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as
cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability 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
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector
investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/
Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company’s news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
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. All showcase company
info is obtained from public filings, news, or directly from management. This site is currently compensated by featured
companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase
biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per
month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com Source - Investorideas.com
biotech/pharma stocks, reports on new trends in the healthcare sector where the industry is
reporting that medical technology is on the rise, and the development of new drugs may be
slowing down. The cost to bring a new drug to market, and the success rates may be a factor
in why some of the leading companies are looking at advancement in medical technology and
devices.
“In our case, we are leveraging our Hemopurifier® device to provide therapeutic capabilities
that target to improve infectious disease and cancer drug therapies,” stated Jim Joyce, CEO of
Aethlon Medical (OTCBB: AEMD).
Partnering technology to advance delivery of drugs is also a key to the future of healthcare. Eli
Lilly and Company (NYSE:LLY) and Medtronic, Inc. (NYSE:MDT) recently announced they have
entered into a collaboration to research and develop a new approach to treating Parkinson's
disease that involves delivering a potential new medicine to the brain using an implantable
drug delivery system. The goal of the collaboration is to develop a therapeutic approach for
Parkinson's disease that combines the strengths of Lilly's biologic, a modified form of glial
cell derived neurotrophic factor (GDNF), with Medtronic's implantable drug infusion system
technology.
As technology plays a key role in healthcare , new players enter the market from within the tech
sector including Apple’s (NasdaqGS: AAPL ) iPad, predicted to potentially revolutionize the
health-care universe.
Sector Snapshot
Aethlon Medical (OTCBB: AEMD) trading at $ 0.0911 - 0.10
Apple Inc.(NasdaqGS: AAPL ) trading at $348.69, down 1.73 (0.49%) 11:40AM EDT
Eli Lilly and Company (NYSE: LLY ) trading up at$ 37.10, up 0.28 (0.76%) 11:41AM EDT
Medtronic Inc.(NYSE: MDT ) trading at $41.38, up 0.14 (0.34%) 11:42AM EDT
Pfizer, Inc. Common Stock(NYSE: PFE ) trading at $20.44, up 0.25 (1.24%) 11:43AM EDT
Market Snapshot
Dow 12,609.68 +14.31 +0.11%
Nasdaq 2,847.00 -0.54 -0.02%
S&P 500 1,346.08 -1.16 -0.09%
10 Yr Bond(%) 3.3680% +0.0480
Oil 112.04 -0.17 -0.15%
Gold 1,508.50 +1.50 +0.10%
Recent article; Are Medical Devices the New Drugs? QMed.com
Published: April 20, 2011
w.qmed.com/mpmn/blog/44335/are-medical-devices-new-drugs
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase profile at Investorideas.com
http://www.investorideas.com/CO/AEMD/
Recent News:
About the Company:
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer.
Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in
disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious
viruses and immunosuppressive proteins from the entire circulatory system. We recently
discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune
system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly
inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer
care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need
and provide the benefit of an immune-based therapy without adding drug toxicity or interaction
risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load
in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients
without the administration of antiviral drugs. However, our initial clinical and commercialization
focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both
infectious disease and cancer treatment regimens. In this regard, we plan to commercialize
our Hemopurifier® in India as we advance our clinical strategies in the United States and the
European Union. In vitro studies conducted by government and non-government research
institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against
bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue
Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1
Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus,
and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market
opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer
therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of
standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected
individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to
address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism
of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery
solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed
for implementation within the established infrastructure of dialysis machines and other blood
circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that
tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer
and glycoproteins residing on the envelope of viruses. These agents are immobilized around
approximately 2800 porous hollow fibers that run the interior length of our device. The resulting
design provides us the novel ability to separate both exosome and viral targets away from blood
cells so they can then be selectively and permanently removed from the circulatory system. In
application, blood circulation is established into the Hemopurifier® via a catheter or other blood
access device. Once blood flow has been established, treatment benefit is immediate as the
entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of
exosome-targeted products and services that improve cancer diagnosis, provide post-treatment
cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient
therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be
accessed online at 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 company's ability to commercialize its Hemopurifier® in India, capability of
the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as
cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability 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
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector
investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/
Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company’s news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
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. All showcase company
info is obtained from public filings, news, or directly from management. This site is currently compensated by featured
companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase
biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per
month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com Source - Investorideas.com
Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at the Deutsche Bank Annual Health Care Conference
LINCOLNSHIRE, Ill. - April 27, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will present at the 36th Annual Deutsche Bank Health Care Conference to be held at the InterContinental Hotel, Boston from May 2-4, 2011.
Phillip B. Donenberg, BioSante's senior vice president, finance & CFO, will speak on Tuesday May 3, 2011 at 4:10 pm EDT. He will provide an overview of the company, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program.
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 future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or 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:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Phillip B. Donenberg, BioSante's senior vice president, finance & CFO, will speak on Tuesday May 3, 2011 at 4:10 pm EDT. He will provide an overview of the company, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program.
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 future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or 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:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Thursday, April 21, 2011
Biotech/Biodefense Stock News; Aethlon Medical (OTCBB: AEMD) Clarifies News Report
SAN DIEGO - April 21, 2011 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB: AEMD) disclosed that it was the subject of an ABC affiliate station news story that included discussion of the company's proposed strategy to reduce the occurrence of sepsis in wounded military personnel. As previously disclosed, the company submitted a contract response on April 1, 2011 to a Broad Agency Announcement (BAA) entitled Dialysis Like Therapeutics (DLT). In the submission, company proposed multiple capabilities including the development of dialysis-like therapy that would address the objectives of the DLT program. The company wishes to clarify that there is no assurance it will be invited to participate in the DLT program and that battlefield deployment of such a device is not feasible in the near future as suggested in the ABC affiliate news story. However, the company does believe that successful clinical outcomes in treating Hepatitis-C (HCV) infected patients with its Hemopurifier� technology does offer the potential for an early commercialization pathway of its Hemopurifier� in India. The company appreciates the coverage by the ABC news affiliate which unfortunately confused the potential commercialization timeline of our Hemopurifier� with the device proposed to be developed in our DLT response.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at 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 company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability 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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at 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 company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability 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
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 ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Effective March 15, 2011
Biotech/Pharma Investor Spotlight; Profile for BioSante Pharmaceuticals (NASDAQ: BPAX) and its Lead Products, LibiGel® and Bio-T-Gel™
Point Roberts, WA - April 21, 2011 (Investorideas.com Newswire) Investorideas.com, a leader in sector stock research including biotech and pharma stocks, profiles BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) and its lead products, LibiGel® (testosterone gel) and Bio-T-Gel.
Hi-lights are featured within the research report, updated product brochure, recent news and a recent Q&A interview.
Recent Equity Research:
"Our $5 price target is derived by applying a 5x multiple to our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year." JMP Securities
Read the full report:
http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
Recent News for LibiGel Product:
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in Both Pivotal LibiGel® Phase III Efficacy Trials
LINCOLNSHIRE , Ill. - March 30, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that enrollment of subjects in the second of two pivotal Phase III LibiGel (testosterone gel) safety and efficacy trials has been completed. Enrollment in the first LibiGel efficacy trial was completed in February. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel 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.
"This is an important achievement for BioSante and a key step toward completing the LibiGel Phase III clinical development program," said Joanne Zborowski, BioSante's vice president of clinical development. "There are more than 1,000 subjects in the efficacy trials and we anticipate announcing top-line efficacy data this fall. In addition, we have over 3,000 subjects enrolled in our LibiGel Phase III safety study," she added.
Read Full News at: http://www.investorideas.com/CO/BPAX/news/2011/03301.asp
Highlights from the LibiGel Brochure:
Read the Full Brochure at: http://www.biosantepharma.com/libigel/LibiGel-Brochure.pdf
Recent News for Bio-T-Gel: Bio-T-Gel NDA pending with PDUFA date of November 14, 2011. NDA filed by Teva
On April 13, 2011, BioSante announced that a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA). The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion .
LibiGel R & D Event
On April 7, 2011, BioSante hosted a review of female sexual dysfunction (FSD) and the safety of testosterone in women by independent experts, as well as an update of the LibiGel (testosterone gel) development program, for institutional investors and analysts in New York City. The full presentations and slides presented at the LibiGel R & D Event are available on BioSante’s website at www.biosantepharma.com
Interview
Full interview with Mr. Simes can be read here: http://www.investorideas.com/CO/BPAX/news/2011/03281.asp
About BioSante Pharmaceuticals, Inc.
BioSante (NASDAQ: BPAX) 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’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 II clinical trials. Other products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
This news release may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will,” "potential,” "could,” "would,” "can,” "believe,” "intends,” "continue,” "plans,” "expects,” "anticipates,” "estimates,” "may,” other words of similar meaning or 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 presentation speak only as of the date of this presentation. 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:
For Investors:
The Trout Group LLC
> Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
The full BPAX company profile is available at Investorideas.com
http://www.investorideas.com/CO/BPAX/
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Sign up for the free investor news letter and get stock alerts in leading sectors! http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (one 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
Contact Investorideas.com 800 665 0411 cvanzant@investorideas.com
Hi-lights are featured within the research report, updated product brochure, recent news and a recent Q&A interview.
Recent Equity Research:
"Our $5 price target is derived by applying a 5x multiple to our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year." JMP Securities
Read the full report:
http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
Recent News for LibiGel Product:
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in Both Pivotal LibiGel® Phase III Efficacy Trials
LINCOLNSHIRE , Ill. - March 30, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that enrollment of subjects in the second of two pivotal Phase III LibiGel (testosterone gel) safety and efficacy trials has been completed. Enrollment in the first LibiGel efficacy trial was completed in February. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel 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.
"This is an important achievement for BioSante and a key step toward completing the LibiGel Phase III clinical development program," said Joanne Zborowski, BioSante's vice president of clinical development. "There are more than 1,000 subjects in the efficacy trials and we anticipate announcing top-line efficacy data this fall. In addition, we have over 3,000 subjects enrolled in our LibiGel Phase III safety study," she added.
Read Full News at: http://www.investorideas.com/CO/BPAX/news/2011/03301.asp
Highlights from the LibiGel Brochure:
Read the Full Brochure at: http://www.biosantepharma.com/libigel/LibiGel-Brochure.pdf
Recent News for Bio-T-Gel: Bio-T-Gel NDA pending with PDUFA date of November 14, 2011. NDA filed by Teva
On April 13, 2011, BioSante announced that a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA). The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion .
LibiGel R & D Event
On April 7, 2011, BioSante hosted a review of female sexual dysfunction (FSD) and the safety of testosterone in women by independent experts, as well as an update of the LibiGel (testosterone gel) development program, for institutional investors and analysts in New York City. The full presentations and slides presented at the LibiGel R & D Event are available on BioSante’s website at www.biosantepharma.com
Interview
Full interview with Mr. Simes can be read here: http://www.investorideas.com/CO/BPAX/news/2011/03281.asp
About BioSante Pharmaceuticals, Inc.
BioSante (NASDAQ: BPAX) 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’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 II clinical trials. Other products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
This news release may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will,” "potential,” "could,” "would,” "can,” "believe,” "intends,” "continue,” "plans,” "expects,” "anticipates,” "estimates,” "may,” other words of similar meaning or 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 presentation speak only as of the date of this presentation. 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:
For Investors:
The Trout Group LLC
> Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
The full BPAX company profile is available at Investorideas.com
http://www.investorideas.com/CO/BPAX/
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Sign up for the free investor news letter and get stock alerts in leading sectors! http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (one 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
Contact Investorideas.com 800 665 0411 cvanzant@investorideas.com
Wednesday, April 20, 2011
Biotech/Biodefense Stock News; ABC News Reports on Aethlon Medical (OTCBB: AEMD)
SAN DIEGO - April 20, 2011 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, disclosed today that it is the subject of an ABC news story that can be accessed online at: http://www.10news.com/news/27605561/detail.html
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® inIndia
as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at 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 company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability 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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at 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 company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability 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
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 ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Effective March 15, 2011
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