Aethlon further disclosed that the principal investigator of the clinical program, which has been registered with the Clinical Trials Registry of India, will be Vijay Kher, M.D., Chairman of the Department of Nephrology at the Medanta Kidney & Urology Institute. Dr. Kher previously served as the principal investigator of Hemopurifier?® human studies to treat HCV at the Apollo and Fortis Hospital in Delhi, India. These studies demonstrated safety and effectiveness of the Hemopurifier?® to reduce viral load in the absence of drug therapy. Patients enrolled in the Medicity study will receive a maximum of six Hemopurifier?® treatments within the first week of initiating SOC drug therapy. In addition to monitoring for improved acceleration of viral load reduction at the outset of SOC, another primary endpoint will focus on rapid viralogic response (RVR) which is defined as undetectable viral load 30 days after SOC initiation. On average, approximately 15% of patients who initiate SOC therapy achieve a RVR. Yet, those able to achieve a RVR have a greater than 88% likelihood of achieving a sustained viralogic response. The initiation of patient enrollment for the Medicity is conditional upon maintaining the treatment protocols approved by the MIEC and that clinical endpoint / efficacy assessment be further clarified by the principal investigator. Aethlon has also agreed to give consideration to compensating enrolled patients for lost wages while receiving Hemopurifier?® treatment and other consideration should a material adverse event occur as a result of Hemopurifier?® therapy.
SOURCE Aethlon Medical, Inc.