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 Medgenics’ Strategic Advisory Board, stated, “This first INFRADURE study will be important not only for its use in treating hepatitis C, but more broadly will calibrate use of this novel method to offer continuous interferon therapy produced by the patient’s own tissue, for other forms of hepatitis such as B and D. The immune system is the body’s natural protection against viral infection and is a key element of treatment for various forms of hepatitis. INFRADURE aims to make the most of that natural defense by providing sustained interferon to bolster the immune system while minimizing the burdens of patient compliance and reducing side effects. INFRADURE offers hope not only in hepatitis C, but could also fulfill an unmet need for reliable interferon therapy for hepatitis D, an aggressive form of hepatitis for which IFNa is the only effective treatment. It also addresses the emerging need for a practical, time limited alternative to years of expensive oral antiviral treatments for hepatitis B, a disease which afflicts an estimated 350 million patients worldwide.”
Bruce R. Bacon, M.D., past President of the American Association for the Study of Liver Disease, a recognized global expert in hepatitis and a member of Medgenics’ Strategic Advisory Board, commented, “Many have been predicting that the use of interferon in treating hepatitis C will be replaced by direct acting oral antiviral agents (DAAs), once these show effectiveness and safety in widespread use. However, recent developments in clinical studies suggest that safety may be an issue for some DAAs and caution is recommended as we go forward in this arena. INFRADURE potentially offers a safe alternative therapy for many of these patients, and supplement to oral treatments in others.”Hepatitis C is the third clinical indication for use of the Biopump tissue-based protein production and delivery platform, to receive clearance for clinical studies, with the first two being Chronic Kidney Disease and End Stage Renal Disease. In addition, in June 2012 FDA approved Orphan Drug Designation for INFRADURE for the treatment of hepatitis D, using INFRADURE Biopumps in a manner similar to that in hepatitis C patients. Worldwide, it is estimated there are 170 million carriers of hepatitis C, with three to four million new infections annually.
“Approval for clinical testing in a third indication underscores the versatility of our Biopump platform,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. “Following the recent Orphan Drug Designation for INFRADURE in hepatitis D, these hepatitis C clinical studies launch our broader hepatitis clinical program. As the first clinical studies of INFRADURE, they will help us develop its use in patients. We believe this not only holds promise for the hepatitis C population, but perhaps even more importantly, will advance the development of INFRADURE to meet the unmet needs in hepatitis D and emerging needs hepatitis B – the largest hepatitis patient population.” 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 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 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.
In addition to treatments for anemia, hepatitis and hemophilia, Medgenics plans to develop and/or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach $132 billion in 2013. Other potential applications for Biopumps include multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity and diabetes.
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