AETHLON MEDICAL ANNOUNCES APPROVAL OF HEPATITIS C VIRUS (HCV) TREATMENT PROGRAM
JULY 29, 2014
Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced that the Medanta Independent Ethics Committee (MIEC) at Medanta, The Medicity Institute (Medicity) has approved a treatment program entitled: “Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy.” The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. The Aethlon Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates.
“We are grateful for this opportunity to show the pharmaceutical industry, infected patients, and shareholders that our Hemopurifier® can enhance the capabilities of drug regimens without adding additional drug toxicity and interaction risks”, stated Aethlon Chairman and CEO, Jim Joyce. “Beneficial outcomes will set the stage for the early commercialization of our technology and should recalibrate industry viewpoints on addressing infectious disease conditions.”
Upon the demonstration of early treatment benefit, Aethlon plans to advance commercialization through the Medicity and other regional treatment centers in India. In this regard, the company has entered into an agreement with GVK Biosciences (GVK BIO) to expand the opportunity for Aethlon to commercialize its Hemopurifier® treatment technology at three to five new clinical centers in India. GVK BIO is Asia’s leading Discovery Research and Development organization. The HCV treatment opportunity for Aethlon is significant as greater than 20 million of the estimated 180 million people infected with HCV worldwide reside in India. Based on patient feedback, Aethlon also believes that citizens of other nations may chose to travel to India to seek treatments that could resolve their HCV infection.
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.