Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the developer of Biopump™, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces the launch of its Phase IIa clinical trial in Israel of EPODURE™ Biopumps to treat anemia in patients with end-stage renal disease (“ESRD” or “kidney failure”) on dialysis, through the sustained delivery of erythropoietin (“EPO”). Following the Israeli Ministry of Health’s recent approval of the trial, Medgenics has enrolled and begun to treat the first two dialysis patients ever to receive EPODURE Biopumps.
Enrollment is expected to continue in the coming months, with up to 20 patients being treated with EPODURE Biopumps. The study will evaluate the ability of EPODURE Biopumps to replace most or all of the injections of EPO or other erythropoietic stimulating agents (“ESAs”) currently used in standard care, while maintaining the patient’s blood hemoglobin level within the desired range. The current standard of care involves years of frequent EPO or ESA injections, which require patient compliance to reliably administer the drug during that time. Each injection is short-lived, typically causing extreme transient elevation of EPO in the patients’ blood, followed by decline to ineffective levels within a few days, so the patient is not receiving sufficient drug until the next injection. The high transient levels of EPO in the blood are a source of safety concern to the U.S. Food and Drug Administration (“FDA”) as well as to many medical experts.
Medgenics’ EPODURE Biopumps aim to provide a cost effective way to maintain hemoglobin within a target physiological range for these patients through the sustained delivery of EPO, which avoid the extreme elevations seen with injection. Medgenics believes that this steady delivery could improve the safety and efficacy of anemia treatments while enhancing patient quality of life by providing a more reliable treatment that reduces or eliminates the need for frequent EPO or ESA injections, while also providing significant cost benefits to payers.