Medgenics’ EPODURE receives FDA clearance to proceed into clinical trials

May 18 2012

Medgenics, Inc. (NYSE MKT: MDGN)(AIM: MEDU)(AIM: MEDG) (the "Company"), developer of the novel Biopump™ technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the U.S. Food and Drug Administration ("FDA" or the "Agency") to proceed with a Phase IIb clinical trial of EPODURE™ for the treatment of anemia in patients undergoing renal dialysis. EPODURE is intended to produce and deliver erythropoietin ("EPO") on a sustained basis. This multi-center, randomized clinical trial will be the first study in the U.S. using the Company's proprietary Biopump™ technology, and will evaluate the safety and efficacy of sustained EPO therapy delivered via Medgenics' EPODURE Biopump. Treatment of anemia in dialysis patients with EPODURE is intended to replace frequent injections of EPO or other erythropoietic stimulating agents ("ESAs").    

"This timely acceptance of our first Investigational New Drug ("IND") to the FDA marks a significant milestone for our Biopump protein platform. We are very pleased with our U.S. regulatory progress and with the interactions with the FDA, allowing us to proceed with the launch of our first U.S. trial," stated Andrew L. Pearlman, Ph.D., Chief Executive Officer of Medgenics. "This trial is significant for Medgenics as a company as well as for patients with anemia, as we anticipate EPODURE could provide a better treatment for anemia in the future."

"We are hopeful that the positive interaction with the FDA for EPODURE bodes well for the Agency's approach to other future indications for our Biopump protein delivery platform technology," added Dr. Pearlman.

The FDA cleared the Phase IIb study protocol based on results from the Company's prior Phase I/II anemia study of EPODURE in Israel, which reported safety and maintenance of hemoglobin for months from a single EPODURE treatment in pre-dialysis patients without requiring injections of EPO or ESAs, as well as on the complete preclinical package. The Company was particularly encouraged that clearance was received within the 30-day required regulatory response period from submission of the IND application and without major issues being raised. Medgenics views this as an early, second validation from an independent critical review in the U.S. of its Biopump platform. The Company announced in March that the National Institutes of Health's Recombinant DNA Advisory Committee had given positive responses to the Company's prior scientific and clinical data and its proposed Phase IIb study protocol.

The Company believes EPODURE has the potential to revolutionize the treatment of anemia by stabilizing hemoglobin levels within a safe range. This approach is designed to keep serum EPO levels within their normal physiological range and avoid excessive levels resulting from bolus EPO injections. This could be important in improving safety and addressing market concerns about the effects of excessive levels of EPO used in the treatment of anemia.