Medgenics Announces EPODURE to be Presented in Poster Session at the American Society of Nephrology's Kidney Week 2012
Study investigating Stabilization of Hemoglobin Levels in Anemic Patients with End Stage Renal Disease using EPODURE Biopumps
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 the Company will be presenting a poster at the upcoming American Society of Nephrology's Kidney Week 2012, taking place from October 30 to November 4 in San Diego.
The poster, titled "Novel Sustained Delivery of Erythropoietin in Hemodialysis Patients for Safer Anemia Control using EPODURE™ Biopumps - Autologous Dermal Tissue Samples Secreting Erythropoietin," presents preliminary data from a Phase IIa clinical trial of EPODURE to treat anemia patients with end stage renal disease (ESRD).
EPODURE is an autologous dermal Biopump capable of the sustained secretion of therapeutic erythropoietin ("EPO") in the body using a small tissue explant from the patient's own skin and processed to continuously produce EPO for many months. The EPODURE Biopump is subsequently implanted subcutaneously into the patient to provide continuous delivery of EPO.
Posters will be showcased in Poster Reception Halls A - C from November 1-3 and will be available for viewing on those days from 9:30 a.m. to 2:30 p.m. with presentations taking place from 10:00 a.m. to 12:00 p.m. Medgenics' poster will be presented at Kidney Week 2012 on Friday, November 2nd.
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.
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.
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.
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.
Dr. Andrew L. Pearlman, +972-4-902-8900
Anne Marie Fields, 212-838-3777
Adam Michael/Joanne Shears/Jamie Hooper
Nomura Code Securities (NOMAD & Joint Broker)
Jonathan Senior/Giles Balleny
SVS Securities plc (Joint Broker)
Alex Mattey/Ian Callaway
KEYWORDS: United States North America California Middle East Israel
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