First Subjects Enrolled In Phase IIa Clinical Trial Of EPODURE Biopumps To Treat Anemia In Patients With End-Stage Renal Disease On Dialysis

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.

In a prior Phase I/Phase II study with EPODURE Biopumps, Medgenics treated pre-dialysis patients with chronic kidney disease. That study, which only allowed for a single fixed dose to each patient, showed that a single administration of EPODURE Biopumps successfully raised or maintained hemoglobin in the therapeutic range for six to 36 months without the need for EPO or ESA injections, while serum EPO levels remained within normal range. This latest Phase IIa study allows for an adjustment of the initial dose based on the patient’s response to the prior EPO injections, which the administration of EPODURE Biopumps aims to replace for many months at a time.

For the first two patients in the current study, the EPODURE procedure has gone well, as in the previous study, and EPO concentrations were confirmed to be elevated within normal range in the patients’ blood in the days following EPODURE administration. This is consistent with the Phase I/Phase II findings, which indicated that EPODURE Biopumps were delivering EPO in the patients. Moving forward, patients will be followed to determine how long their hemoglobin levels remain in the desired range while EPO levels remain within normal range.

“Our planned Phase II studies will provide valuable insight into extending the use of EPODURE from treating anemia in pre-dialysis patients to treating the anemia of dialysis patients – the largest segment of the anemia market. Although it is very early, we are pleased to see that EPODURE is performing similarly in dialysis patients as it did in pre-dialysis patients, providing us further confidence in EPODURE and in the Biopump platform. While we continue our Phase IIa study in Israel, we are preparing for the launch of the larger, Phase IIb study in dialysis patients in the U.S. before the end of this year. Once completed, we believe that 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 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, 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 for many months 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 has launched a Phase IIa trial in dialysis patients 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 is awaiting final approval of the Israeli Ministry of Health of two Phase I/II trials in Israel in hepatitis C, slated to commence Q3 2012; and which 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 is now in development.

Medgenics is focused on the development and manufacturing of its innovative Biopumps, aiming to 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.

Forward-looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

Copyright Business Wire 2010

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