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.”
Bruce R. Bacon, M.D., Saint Louis University and past President of the American Association for the Study of Liver Disease, a recognized global expert in hepatitis and a member of the Company’s Strategic Advisory Board, reacted to the meeting, saying, “Colleagues who participated in the meeting and I were particularly excited about INFRADURE use as a supplement to oral drugs to address their unmet need to improve HBV surface antigen clearance. We also concurred that INFRADURE could fulfill an unmet need for reliable interferon therapy for hepatitis D, a particularly aggressive form of hepatitis for which years of interferon therapy is the only effective treatment. Though an orphan disease in the U.S., our European colleagues pointed out that hepatitis D is becoming a significant cause of death in Europe. This has now captured the attention of hepatologists in the U.S., where the AASLD held its first special session dedicated to hepatitis D this year. My colleagues agreed that if the upcoming INFRADURE trial in hepatitis C shows signs of effectiveness, it will also be promising for its use in hepatitis D as well as hepatitis B.”Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, added, “Confirmation by this group of esteemed experts on the potential application of INFRADURE in hepatitis B and D represents an important milestone for the hepatitis program using our Biopump™ platform. We are extremely appreciative of their valuable input on our proposed development plans for INFRADURE.” About Medgenics Medgenics is developing and commercializing Biopump™, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in development based on this technology:
- EPODURE™ to produce and deliver erythropoietin from a single administration, which has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for periods of six months to more than 36 months in a Phase I/II dose-ranging trial in Israel and is currently in a Phase IIa trial in dialysis in Israel. An Investigational New Drug application has been cleared by the FDA to initiate a Phase IIb study to evaluate the safety and efficacy of EPODURE in the treatment of anemia in dialysis patients in the U.S.
- INFRADURE™ for sustained production and delivery of interferon-alpha for use in the treatment of hepatitis, which has received approval for two Phase I/II trials in hepatitis C from the Israeli Ministry of Health with the first slated to commence in Q4 2012; and has received Orphan Drug Designation from the FDA for the treatment of hepatitis D.
- HEMODURE™ for sustained production and delivery of clotting Factor VIII therapy for the sustained prophylactic treatment of hemophilia, which is now in development.