10 Aug 2012, BioSpectrum Bureau , BioSpectrum
New Delhi: Aethlon Medical, a pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, has agreed to establish a treatment program that will provide HCV-infected individuals with expanded access to Hemopurifier therapy.
The program is being initiated with support from the Institutional Review Board at the Medanta Medicity Institute (Medicity), one of India's largest multi-super specialty institutes located in Gurgaon, India, to allow compassionate usage of the Aethlon Hemopurifier for individuals who previously failed or subsequently relapsed standard-of-care drug regimens.
HCV-infected individuals from the US, European Union and other regions of the world can also pursue treatment through the expanded access program. Details related to treatment protocol, inclusion criteria, patient approval processes and therapy pricing are anticipated in September. It is estimated that approximately 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is a leading cause of liver transplantation.
The Aethlon Hemopurifier is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dose, duration and tolerability of drug therapies. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India.
"The Medicity access program represents an important milestone in our quest to establish the selective therapeutic filtration industry," said Mr Jim Joyce, chairman and CEO, Aethlon. "Beyond helping HCV-infected individuals overcome their disease, we now have the opportunity to augment our established government contract revenues with Hemopurifier product sales."
Aethlon also disclosed that it will continue conducting a study at the Medicity that is evaluating the capability of the Aethlon Hemopurifier to accelerate HCV RNA depletion at the outset of standard of care peginterferon+ribavirin (PR) therapy. Specifically, HCV-infected individuals are enrolled to receive up to three, six-hour Hemopurifier treatments during the first three days of PR drug therapy. Last week, Aethlon reported that the two most recent HCV infected patients to receive Hemopurifier therapy in combination with PR drug therapy achieved undetectable viral load at day-7, which is rarely reported in drug therapy alone.