SAN DIEGO, Dec. 13, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that researchers have discovered that the Aethlon Hemopurifier® is able to capture particles known as Nef protein exosomes, which contribute to the progression of human immunodeficiency virus (HIV) infection to acquired immunodeficiency syndrome (AIDS). The Aethlon Hemopurifier® is a first-in-class therapeutic device that selectively targets the clearance of viruses, immunosuppressive proteins, and disease enhancing exosomes from the entire circulatory system.
Nef or "Negative Factor" protein is a highly abundant HIV accessory protein that plays an essential role in AIDS progression, yet has eluded HIV drug discovery efforts. Nef protein is secreted from infected cells in small membrane-bound packages called "exosomes." These exosomes fuse with non-infected cells and cause a variety of effects, including programmed cell death of CD4+ immune cells, the hallmark of AIDS. The Hemopurifier® provides a strategy to address Nef exosomes, which are present in the blood of HIV infected individuals. In an ex vivo validation study conducted by researchers at Morehouse School of Medicine, a small-scale Hemopurifier® reduced the presence of Nef exosomes in cell-culture fluids by greater than 85% in less than 24 hours. The outcome represents the first demonstration that a medical device can selectively target Nef exosomes.
"It is becoming increasingly clear that many viruses, including HIV, exploit the mechanisms of exosome production for their secretion and pathogenesis," stated Michael Powell, Ph.D., Associate Professor and Director of Proteomics, Microbiology, Biochemistry, and Immunology at Morehouse School of Medicine. "Therefore, therapies that target circulating exosomes hold great promise to advance antiviral strategies."
In addition to Nef exosomes, the Hemopurifier® is the subject of multi-cancer studies against tumor-secreted exosomes that facilitate the ability of cancerous tumors to evade the immune response. Tumor-secreted exosomes are also implicated in the survival, growth, and metastasis of cancer. Additionally, the Hemopurifier® is being evaluated in human studies as an adjunct therapy to improve outcomes of HCV patients receiving interferon therapy.
"First and foremost, our clinical focus is to demonstrate that our Hemopurifier® improves the benefit of Hepatitis-C virus (HCV) therapies," stated Jim Joyce, CEO and founder of Aethlon Medical. "However, when considering our previous HIV treatment experience, the emerging insight that we can address Nef exosomes provides a further basis for us to pursue clinical opportunities to treat HIV-infected individuals."
In a previous proof-of-principle study, an HIV-infected dialysis patient diagnosed with AIDS received Hemopurifier® therapy during his normal dialysis treatment, resulting in the administration of three weekly Hemopurifier® treatments over the period of one month. The study was conducted in the absence of any antiviral drug administration. In addition to demonstrating treatment safety in an immune-compromised AIDS patient, HIV viral load of the patient was reduced from 102,759 iu/ml at the beginning of treatment one to a final value of 7,978 iu/ml at the end of treatment twelve, representing a 92% reduction. Viral load remained 56% below initial testing values when measured 14-days after last Hemopurifier(r) therapy. Additionally, CD4 t-cell to lymphocyte ratios increased from 13.5% to 18.05% during the study. A ratio below 15% represents a clinical definition of AIDS. The study was conducted at the Sigma New Life Hospital in India.
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 Hemopurifier's® ability to capture tumor-secreted exosomes and to capture Nef protein exosomes and the impact that capture may have on disease conditions, the ability to successfully complete the Medanta HCV study and achieve positive results, 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.
James A. Joyce
Chairman and CEO
Senior Vice President, Lippert/Heilshorn & Associates
Chief Financial Officer
John P. Salvador
SOURCE Aethlon Medical, Inc.