The Aethlon presentation discusses the specificity of the Aethlon Hemopurifier® to address evolved glycopathogen targets that are instrumental in cancer and infectious disease progression. Significant points addressed in the presentation include emerging knowledge of exosome secretion, which is a notable feature of malignancy owing to the diverse roles of these particles in tumor-mediated immune suppression, angiogenesis, metastasis, and resistance to therapeutic agents. As cancer-secreted exosomes remain a critical target not addressed by drug therapies, the Company is expanding the potential utility of the Hemopurifier® to include cancer. In this role, the Hemopurifier® provides an adjuvant strategy to improve current and emerging cancer treatment outcomes without adding drug toxicity. To date, pre-clinical Hemopurifier® studies have validated the capture of exosomes underlying breast cancer, metastatic melanoma, ovarian cancer, lymphoma, and colorectal cancer.
The Aethlon Hemopurifier® consists of the lectin Galanthus nivalis agglutinin (GNA) immobilized in the outer-capillary space of a plasma membrane device that is compatible for use with standard CRRT and dialysis units. GNA-based capture is mediated by unique high mannose signatures abundant on the surface of cancer-secreted exosomes as well as glycoproteins that reside on the outer membrane of infectious viral pathogens.
In human studies of treatment naive HIV and Hepatitis-C (HCV) infected individuals, Hemopurifier® therapy demonstrated average viral load reductions of greater than 50% during single four-hour treatment applications. A three-treatment Hemopurifier® protocol combined with interferon-based standard-of-care resulted in undetectable HCV in as little as seven days in hard-to-treat genotype-1 patients. In this same clinical program, post-treatment elution studies documented the capture of up to 300 billion HCV copies by the Hemopurifier® during a single six-hour treatment. A human feasibility study to initiate HCV human studies in the United States is pending IDE approval by the U.S. Food and Drug Administration (FDA).
Based on human treatment experience and exosome capture validations, the Company has identified candidate research centers to conduct a Hemopurifier® therapy study in cancer patients.