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.”
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.