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Medgenics Presents Expanded Results of Phase I and II Study of EPODURE Biopump for the Treatment of Anemia

Wed, 11/16/2011 - 5:12am
MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that positive data from a Phase I/II clinical trial of EPODURE to treat anemia in chronic kidney disease patients was highlighted in a poster presentation at the American Society of Nephrologys Kidney Week 2011, held November 8-13 in Philadelphia. The poster, titled "Sustained Erythropoiesis 6-30 months by the EPODURE Biopump in Patients with Chronic Kidney Disease: Further Results of Phase I/II Proof of Concept Trial," was presented November 11th by Dr. Allen Nissenson of the David Geffen School of Medicine at UCLA.

The goal of this open-label, dose-ranging study in anemic chronic kidney disease (CKD) patients was to demonstrate EPODUREs ability to provide more than six months of sustained erythropoietin (EPO) delivery from a single treatment using autologous 30mm x 2mm dermis core biopsies excised from the patients skin under local anesthetic, and converted in days into Biopump EPO production units by introducing the EPO genes into cells of the intact explant. This poster reports the results in 13 patients (4 EPO-naïve, 9 EPO-dependent) treated 6-30 months with 20 or 40 IU/kg/day EPODURE implanted dose.

Key Study Findings

  • The brief procedure was well tolerated and there were no adverse events in any patients treated
  • There were no anti-EPO antibody formations and no serum EPO levels to date above 60 mU/ml
  • EPODURE treatment elevated hemoglobin levels and maintained >9 g/dl for >3 months in 12/13 patients and >6 months in 7 /13 patients, with the longest >30 months
  • EPODURE treatment maintained hemoglobin between 10-12 g/dl in 10/13 patients for >3 months and 6/13 patients for >6 months, with the longest >30 months

Commenting on the results of the study, Dr. Nissenson said, "Treatment with EPODURE was found to be safe and doseable, with no antigenic response. We were pleased to have demonstrated clinical feasibility showing that a single EPODURE administration can raise and maintain hemoglobin levels for up to 30 months without any injections of erythropoietic stimulating agents (ESAs). These data highlight EPODUREs significant potential to become an effective interventional treatment – a paradigm shift in the way we treat anemic patients."

According to Andrew L. Pearlman, President and Chief Executive Officer of Medgenics, "We are very encouraged by these positive data and look forward to advancing the clinical development of EPODURE to treat anemia. Toward that end, we remain on track to file an Investigation New Drug application with the U.S. Food and Drug Administration for a Phase IIb clinical trial of EPODURE by mid-2012. A safe, sustained delivery of EPO could reduce the risks of hemoglobin variability while achieving the recommended hemoglobin targets, thereby avoiding the supraphysiologic EPO concentrations associated with the current injections of ESAs. It also could significantly improve the logistics of anemia management to the benefit of both patients and payors."

To request a copy of the poster, please contact Anne Marie Fields, Senior Vice President of LHA, at afields@lhai.com.

About Kidney Week 2011

Kidney Week 2011 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 skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. 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 (now completing a Phase I/II dose-ranging trial) to produce and deliver erythropoietin for many months from a single administration, has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for six to more than 36 months;
  • INFRADURE (planning to commence a Phase I/II trial in Israel in 1H12 in hepatitis C) to produce a sustained therapeutic dose of interferon-alpha for use in the treatment of hepatitis;
  • HEMODURE is a sustained Factor VIII therapy for the prophylactic treatment of hemophilia, now in development.

Medgenics intends to develop its innovative products and bring them to market via strategic partnerships with major pharmaceutical and/or medical device companies.

In addition to treatments for anemia, hepatitis and hemophilia, Medgenics plans to develop and/or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach $132 billion in 2013. Other potential applications for Biopumps include multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity and diabetes.

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