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.
Medgenics’ EPODURE Biopumps aim to provide a cost-effective way to maintain hemoglobin within a target physiological range for anemic patients through the sustained delivery of EPO, while avoiding the extreme elevations seen with injections. 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, and also provides significant cost benefits to payers.“We believe that this Phase IIa study will provide valuable insight into the use of EPODURE to treat anemia in patients on dialysis, which is the largest segment of the anemia market. Although the findings presented at Kidney Week 2012 are on only three patients, we are thus far encouraged by this ongoing study. Full study results can be supportive of the larger Phase II study in dialysis patients in the U.S., now slated to begin in the first half of 2013. Once completed, we believe these studies will provide data to support the use of EPODURE in the treatment of anemia from chronic kidney disease,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. About Kidney Week 2012 Kidney Week 2012 is the world's premier nephrology meeting. More than 13,000 kidney professionals from around the globe come together to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative exchanges between leading experts in the field. About Medgenics Medgenics is developing and commercializing Biopump™, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in development based on this technology:
- EPODURE™ to produce and deliver erythropoietin from a single administration, which has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for periods of six months to more than 36 months in a Phase I/II dose-ranging trial in Israel and is currently in a Phase IIa trial in dialysis in Israel. An Investigational New Drug application has been cleared by the FDA to initiate a Phase IIb study to evaluate the safety and efficacy of EPODURE in the treatment of anemia in dialysis patients in the U.S.
- INFRADURE™ for sustained production and delivery of interferon-alpha for use in the treatment of hepatitis, which has received approval for two Phase I/II trials in hepatitis C from the Israeli Ministry of Health with the first slated to commence in Q4 2012; and has received Orphan Drug Designation from the FDA for the treatment of hepatitis D.
- HEMODURE™ for sustained production and delivery of clotting Factor VIII therapy for the sustained prophylactic treatment of hemophilia, which is now in development.