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, announced the presentation of preliminary data from its ongoing Phase IIa clinical trial in Israel with EPODURE™ Biopumps to treat anemia in patients on dialysis with end-stage renal disease (“ESRD”), by sustained delivery of erythropoietin (“EPO”). Data from the first three patients were highlighted in a poster presentation today at the American Society of Nephrology’s Kidney Week 2012, which is being held from October 30 through November 4 in San Diego. The poster is titled “Novel Sustained Delivery of Erythropoietin in Hemodialysis Patients for Safer Anemia Control using EPODURE™ Biopumps – Autologous Dermal Tissue Samples Secreting Erythropoietin.”
As the first study with EPODURE Biopumps in ESRD patients, the Phase IIa study is testing administration techniques and dosing to determine if EPODURE can replace most or all of the injections of EPO or other erythropoietic stimulating agents (“ESAs”) currently used in the standard care of such patients, while maintaining blood hemoglobin levels within the desired range. The current standard of care involves frequent EPO or ESA injections, which require patient compliance for reliable administration. Each injection is short-lived, typically causing an extreme transient elevation of EPO in the patient’s blood, followed by a decline to ineffective levels within a few days, so the patient may not have sufficient EPO or ESA until the next injection. The high transient levels of EPO in the blood are a source of potential safety concern to many medical experts as well as to the U.S. Food and Drug Administration (“FDA”).
Consistent with the earlier Phase I/II study with EPODURE in pre-dialysis patients, the EPODURE procedure went well in these first dialysis patients. These patients will continue to be monitored and enrollment in the study is continuing.