Medgenics, Inc. Receives FDA Clearance to Commence Phase IIb Trial of EPODURE for Sustained Anemia Treatment in Dialysis Patients
5/17/2012 10:05:41 AM
MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--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”).