Medgenics has filed an investigational new drug (IND) application with the 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.
EPODURE is an autologous dermal Biopump, a small tissue implant made from the patient's own dermal (skin) tissue.
The biopumps are processed to enable the continuous production of EPO, and are subsequently implanted subcutaneously.
Medgenics president and chief executive officer Andrew Pearlman said: "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."
