Human Safety Study
On September 20, 2005, Aethlon initiated a human clinical trial to demonstrate safety of the viral treatment Hemopurifier® at the Apollo Hospital in New Delhi, India. The Apollo Hospital Group is the fourth largest private healthcare group in the world and the largest in Asia. It has performed clinical studies for Pfizer, Eli Lilly & CO., and a host of other biotechnology organizations. The data obtained in this study will be submitted as part of future regulatory initiatives to demonstrate further safety and potential efficacy of the Hemopurifier® in viral treatment applications. This may include studies related to the deployment of the Hemopurifier® as a countermeasure against drug and vaccine resistant bioweapons, naturally evolving pandemic threats, and chronic infectious disease targets such as HCV and the Human Immunodeficiency Virus (HIV).
The individuals (5 patients) enrolled in the Hemopurifier® safety study are Hepatitis-C (HCV) infected patients that require kidney dialysis as a result of End Stage Renal Disease (ESRD). Approximately 30-35% of all ESRD patients are infected with HCV, and as a result of their condition, are unable to endure the toxicity of HCV drug treatment. Dr. Vijay Kher, Senior Consultant of Nephrology at the Apollo Hospital has been retained as the Principal Investigator in the Aethlon clinical study. Dr. Kher has over 30 years of clinical experience, is the recipient of numerous medical awards, and has been credited with over 100 scientific publications. Following a Clinical and Research fellowship at Henry Ford Hospital, Detroit and the University of Cincinnati, Dr. Kher served as a visiting professor to several Universities, including the University of Cincinnati, Loyola University, Rutgers, and the University of Chicago. Mr. Sunil Sawhney, the former Director of Boston Scientific India, and other regulatory advisors from Qualtran, LLC have been retained to manage the study on behalf of Aethlon Medical.