Medgenics, Inc. Files IND Application for EPODURE Biopump Phase IIb Anemia Study in Dialysis Patients
Published: Apr 17, 2012
MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--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”).