“The FDA’s timely approval of our Orphan Drug Designation for INFRADURE to treat hepatitis D is a key milestone in our broader hepatitis program as data gathered through clinical trials for INFRADURE in hepatitis D may serve as relevant support for other clinical uses of INFRADURE including hepatitis C and hepatitis B,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. “Following on the FDA’s recent clearance to proceed with our Phase IIb study of the EPODURE™ Biopump technology to treat anemia, and the positive comments of the National Institutes of Health Recombinant DNA Advisory Committee, we see this Orphan Drug Designation from the FDA as another important step in the regulatory pathway for our Biopump platform. As Dr. Haffner has indicated, we are hopeful that this will lead to a streamlined regulatory pathway to approval of INFRADURE in hepatitis D and believe that it could also help advance the regulatory pathway for other applications of our Biopump technology in the U.S.”“We look forward to updating our clinical trial plans in view of the Orphan Drug Designation. We anticipate that hepatitis D clinical studies will use INFRADURE Biopumps that are fundamentally identical to those which will be used for the treatment of hepatitis C in our two Phase I/II studies in Israel which are now awaiting final approval from the Israeli Ministry of Health.” added Pearlman. About Hepatitis D According to the U.S. Centers for Disease Control and Prevention, hepatitis D, also known as "delta hepatitis," is a serious liver disease caused by infection with the hepatitis D virus (HDV), which is an RNA virus structurally unrelated to the hepatitis A, B or C viruses. Hepatitis D, which can be acute or chronic, is not common in the United States. HDV is an incomplete virus that requires the helper function of the hepatitis B virus (HBV) to replicate and only occurs among people who are infected with HBV. HDV is transmitted through percutaneous or mucosal contact with infectious blood and can be acquired either as a co-infection with HBV or as a super-infection in persons with HBV infection. There is no vaccine for hepatitis D, but it can be prevented in persons who are not already HBV-infected by administrative of the hepatitis B vaccination. Hepatitis D infects about 15 million people worldwide.
About MedgenicsMedgenics 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 skin biopsy 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 TM to produce and deliver erythropoietin for many months 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 has received approval for a Phase IIa trial in dialysis patients due to launch in Q2 2012 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 TM for sustained production and delivery of interferon-alpha for use in the treatment of hepatitis is awaiting final approval of the Israeli Ministry of Health of two Phase I/II trials in Israel in hepatitis C, slated to commence Q3 2012.
- HEMODURE TM for sustained production and delivery of clotting Factor VIII therapy for the sustained prophylactic treatment of hemophilia is now in development.
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