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.
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