Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that during the recent annual conference of the American Association for the Study of Liver Disease (AASLD) in Boston, it convened an active roundtable of top liver experts and regulatory advisors from the United States, Europe, Israel and Australia to discuss INFRADURE™ ,which the Company is developing to provide sustained interferon therapy for the treatment of hepatitis. Fifteen key opinion leaders in hepatitis met to interactively review Medgenics’ INFRADURE for its potential applications in the treatment of hepatitis B and hepatitis D. The session provided key input reflecting the latest clinical developments in hepatitis to optimize the clinical development strategy and regulatory approach for INFRADURE.
INFRADURE is designed to provide sustained interferon therapy using the patient’s own dermis tissue processed to produce and deliver interferon alpha continuously in the patient for months from a single treatment. Hepatitis B affects more than 350 million people worldwide and approximately 1.3 million in the U.S. Hepatitis D, an aggressive form of hepatitis, affects some 15 million people worldwide, and is estimated to afflict tens of thousands in the U.S. Hepatitis C affects an estimated 180 million people worldwide and 3 to 4 million in the U.S.
Nezam H. Afdhal, M.D., Chief of Hepatology, Director of Liver Center, Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard School of Medicine, and a member of the Company’s Strategic Advisory Board who helped organize the meeting, commented, “This group of top leaders in the field of hepatitis concurred that INFRADURE holds much promise in addressing the unmet need in the treatment of hepatitis B, namely to eliminate the hepatitis B virus (HBV), not just contain it. Years of expensive oral antiviral treatments have not eliminated the HBV. Instead these treatments have acted to contain the disease as long as the patient takes them, with mounting costs and health risks. The group agreed that the gold standard of treating HBV is to eliminate the hepatitis B surface antigen (HBsAg) by activating the immune system to fight it, known as sero-conversion – which is attained in only a small percentage of patients using oral antiviral agents and only after long-term use. Sero-conversion against HBV and surface antigen elimination has been reported to be improved by one-to-two years of interferon alpha therapy. However, today this requires the patient to endure weekly injections of pegylated interferon alpha with its associated side effects, creating a significant challenge in patient compliance to complete treatment. INFRADURE has the potential to provide a much more practical and patient-compliant way to attain sero-conversion or surface antigen loss in a large proportion of patients by having the patient’s own tissue produce and deliver the protein instead of using injections, whether supplemental to oral treatments, or on its own.”