Medgenics Inc (MDGN) Thursday announced that the U.S Food and Drug Administration or the FDA granted its consent to the company to proceed with a Phase IIb clinical trial of EPODURE for the treatment of anemia in patients undergoing renal dialysis.
The company stated that EPODURE is intended to produce and deliver erythropoietin, or EPO, on a sustained basis.
The company further added that the 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.
"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.
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