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 the Company will be presenting a poster at the upcoming American Society of Nephrology’s Kidney Week 2012, taking place from October 30 to November 4 in San Diego. The poster, titled “Novel Sustained Delivery of Erythropoietin in Hemodialysis Patients for Safer Anemia Control using EPODURE™ Biopumps – Autologous Dermal Tissue Samples Secreting Erythropoietin,” presents preliminary data from a Phase IIa clinical trial of EPODURE to treat anemia patients with end stage renal disease (ESRD). EPODURE is an autologous dermal Biopump capable of the sustained secretion of therapeutic erythropoietin (“EPO”) in the body using a small tissue explant from the patient’s own skin and processed to continuously produce EPO for many months. The EPODURE Biopump is subsequently implanted subcutaneously into the patient to provide continuous delivery of EPO. Posters will be showcased in Poster Reception Halls A - C from November 1-3 and will be available for viewing on those days from 9:30 a.m. to 2:30 p.m. with presentations taking place from 10:00 a.m. to 12:00 p.m. Medgenics’ poster will be presented at Kidney Week 2012 on Friday, November 2nd. About Kidney Week 2012 Kidney Week 2012 is the world's premier nephrology meeting. More than 13,000 kidney professionals from around the globe come together to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative exchanges between leading experts in the field. 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.