Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) to initiate a Phase IIb multi-center, 100-patient clinical trial. The trial is designed to evaluate the safety and efficacy of sustained erythropoietin (“EPO”) therapy delivered via the Company’s EPODURE Biopump™ for the treatment of anemia in dialysis patients with end-stage renal disease (“ESRD”).
EPODURE is an autologous dermal Biopump, a small tissue implant made from the patient’s own dermal (skin) tissue. EPODURE Biopumps are processed to enable the continuous production of EPO, and are subsequently implanted subcutaneously. Positive data from the Company’s Phase I/II dose-ranging study of EPODURE in pre-dialysis patients were presented at the 2010 and the 2011 American Society of Nephrology Annual Meetings, and demonstrated that a single administration can raise and maintain hemoglobin levels for many months without any injections of EPO or other erythropoietin stimulating agents (“ESAs”).
The filing of this IND application follows two key events that occurred in March 2012: the regulatory approval for a smaller Phase IIa study for the same indication in Israel; and positive meetings with the National Institutes of Health’s Recombinant DNA Advisory Committee in the U.S.
“This IND filing is our first with the FDA and marks a significant milestone for Medgenics. It is one of many key catalysts we have targeted for our Company in 2012. We anticipate receiving the FDA’s comments in May, which we believe could lead to trial approval in the third quarter of 2012,” said Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. “Filing for the anemia indication of our platform technology is a key step not only for EPODURE, but helps pave the way for multiple future indications that address multibillion-dollar markets.”