- Published: 02 October 2012
- Written by Investor Ideas
SAN DIEGO - October 2, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today released the treatment protocol underlying a program that will provide hard-to-treat HCV-infected individuals with expanded access to Hemopurifier® therapy. The Company also disclosed inclusion and exclusion criteria for candidate patients as well as details on the physicians who will administer the program, which is expected to generate first product sales of the Aethlon Hemopurifier®.
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The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capability to address infectious viral pathogens and immunosuppressive exosomes underlying cancer and other life-threatening conditions. In the expanded access program, Hemopurifier® therapy will be administered to selectively target the rapid clearance of HCV from the entire circulatory system to improve benefit, dose, duration and tolerability of standard-of-care drug therapy. The program is being initiated with support from the Institutional Review Board at the Medanta Medicity Institute (Medicity) to allow compassionate usage of the Aethlon Hemopurifier® for individuals who previously failed or subsequently relapsed standard-of-care drug regimens. The Medicity is a leading center for medical tourism in India.
In addition to offering Hemopurifier® therapy to the citizens of India, HCV-infected individuals from the United States, European Union and other regions of the world may pursue treatment through the expanded access program. It is estimated that approximately 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is a leading cause of liver transplantation.
"We are grateful for the opportunity to provide hard-to-treat HCV-infected individuals with access to Hemopurifier® therapy," stated Aethlon Chairman and CEO, Jim Joyce. "Beyond advancing our therapeutic objectives, the resulting Hemopurifier® product sales will augment the government contract revenue stream we established this past year."
Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in ten treated patients. Of these ten patients, seven patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. At present, undetectable HCV RNA is reported in eight of the 10 treated patients. Of the two patients with detectable HCV RNA, one discontinued PR therapy as a result of a diabetes related condition. HCV RNA is undetectable in all patients (n=4) that have been monitored for 48 weeks since receiving Hemopurifier® therapy. Among the 10 treated patients, Aethlon reported that six genotype-1 patients received the three treatment Hemopurifier® protocol, which resulted in four (67%) patients achieving a RVR. The IDEAL study predicts it would normally require approximately 40 PR treated patients to achieve 4 RVR outcomes. Both patients who achieved undetectable HCV RNA at day-7 also achieved a RVR. Beyond the high likelihood of a SVR, genotype-1 patients that achieve a RVR also have the opportunity to reduce the duration of PR drug therapy from 48 weeks to 24 weeks.
About Aethlon Medical
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
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Jim Frakes
Chief Financial Officer
858.459.7800 x300
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Marc Robins
877.276.2467
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