Aethlon Medical starts patient enrollment of Hemopurifier in battle against HCV...

From the PharmaLive.com News Archive - Oct. 21, 2010
SAN DIEGO, Oct. 21 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today it has established primary clinical endpoints and clarified efficacy assessments related to a study that will evaluate the use of the Aethlon Hemopurifier® in combination with standard of care (SOC) HCV drug therapy.  As a result, Aethlon will now initiate the recruitment of candidate patients and begin exporting its Hemopurifier® for clinical purposes.  The study will be conducted at Medanta, The Medicity Institute (Medicity), which 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 a first-in-class medical device that selectively targets the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system.

A primary clinical goal of the study will be to demonstrate that the Aethlon Hemopurifier® improves the acceleration of viral load depletion when administered at the outset of SOC drug therapy. Clinical endpoints of the study will assess Early Viral Response (EVR) rates, Rapid Viral Response (RVR) rates, as well as Immediate Viral Response (IVR) rates, which are all highly predictive of a sustained viral response (SVR), which is defined as undetectable viral load six months after the completion of SOC drug therapy.  As the Hemopurifier® is designed to decrease the presence of circulating HCV virus, Aethlon will also seek to quantify the amount of HCV captured within the Hemopurifier® after the first application of the device in each enrolled patient. A lower body burden of HCV at the outset of SOC also correlates with improved treatment outcomes.

Early Viral Response (EVR)
As reported in the McHutchinson, et al 2009 study of 1,019 genotype I patients who initiated 48-week standard dose SOC PegIFN-a2b therapy, 39.9% of treated patients achieved an EVR.  Those patients who achieved an EVR, which represents undetectable viral load at day 90 of SOC treatment, achieved 99% SVR rates, representing an improved clinical benefit of greater than 200% as compared to patients that do not achieve an EVR.  A clinical goal of the Hemopurifier® study will be to increase the established likelihood that patients achieve an EVR.

Rapid Viral Response (RVR)
Also reported in the McHutchinson, et al 2009 study of 1,019 genotype I patients who initiated 48-week standard dose SOC PegIFN-a2b therapy, only 11.4% of treated patients achieved a RVR, which is defined as undetectable viral load at day 30.  However, those patients who achieved an RVR had SVR rates of approximately 90%, which represents a clinical benefit greater than 100% as compared to patients that do not achieve an RVR.  An additional clinical goal of the Hemopurifier® study will be to increase the likelihood that patients achieve an RVR.

Immediate Viral Response (IVR)
Aethlon will also seek to demonstrate that the addition of the Hemopurifier® to SOC drug therapy improves Immediate Viral Response (IVR) rates as compared to patients who receive SOC alone.  IVR, also known as first-phase kinetics, will be determined by measuring viral load at the end of day one (1), day two (2), day three (3), and day seven (7).  In this regard, an additional clinical goal will be to demonstrate the application of the Hemopurifier® in combination with SOC improves first-phase viral depletion kinetics in enrolled patients.
The principal investigator of the clinical study, 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 hospitals in Delhi, India. The Apollo and Fortis studies demonstrated safety and the 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.   The study will enroll up to 30 patients.

Upon the demonstration of improved clinical outcomes, Aethlon plans to advance commercialization through the Medicity and other regional treatment centers in India. 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 it is estimated that 20 million of the 180 million people infected with HCV worldwide reside in India.  Based on patient feedback, Aethlon also believes that citizens of other nations that are infected with HCV may choose to travel to India to seek out new therapies that could help address their HCV infection. However, Medanta's Independent Ethics Committee (MIEC) has not yet approved the enrollment of treatment candidates who reside outside of India.