Medgenics Provides Clinical and Regulatory Update
November 09, 2011 10:06 AM Eastern Time
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 provided a clinical update on the Company's progress with the development of its Biopump which is being developed for the treatment of a range of chronic diseases including anemia and hepatitis C.
"Moving forward, we are very excited about the opportunities for Medgenics' Biopump in a variety of therapeutic indications and look forward to continuing to advance our technology both through internal development and through collaborations"
Discussing the Company's clinical progress, Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, said, "We have continued to make important advances with the clinical development of the Biopump in a number of indications. We held a positive and productive meeting with the U.S. Food and Drug Administration ("FDA") to discuss our proposed protocol for a Phase IIb clinical trial of EPODURE to treat anemia in patients with renal failure, and the route to regulatory approval for EPODURE in the U.S. We were pleased and encouraged by our dialogue with the FDA and appear to be well on track with our plans to file an Investigational New Drug ("IND") application for the Phase IIb study in mid-2012.
"We look forward to the presentation of the updated results of our Phase I/II dose-ranging trial of EPODURE to treat anemia in pre-dialysis, chronic kidney disease patients in a poster presentation on November 11th at the American Society of Nephrologists by Dr. Allen Nissenson of the David Geffen School of Medicine at UCLA. The study has demonstrated sustained elevation and stabilization of hemoglobin levels in anemic patients, with most remaining non-anemic without the need for injections of erythropoietic stimulating agents ("ESAs") for six to more than 30 months from a single administration of EPODURE Biopumps, without any reported adverse events. We view this as particularly remarkable given that in this dose ranging study patients were restricted to treatment with a single, fixed dose that was not tailored to the patient's needs or adjusted to optimize response to treatment. In addition, we have obtained Investigational Review Board ("IRB") approval from Tel Aviv Medical Center in Israel for a Phase II clinical trial of EPODURE to treat anemia patients on kidney dialysis and are awaiting final approval from the Israeli Ministry of Health, which we expect to be cleared to initiate during the first quarter of 2012. This will be our first trial in dialysis patients and the first in which we will be able to adjust the dose to meet patients' needs.
"We have also made substantial strides towards the approval and launch of our first studies of Biopumps in the treatment of hepatitis C. We submitted protocols and have obtained IRB approval from Hadassah Medical Organization and Tel Aviv Medical Center in Israel, for two Phase I/II clinical studies using INFRADURE to demonstrate continuous production and delivery of interferon-alpha for the treatment of patients with hepatitis C. These protocols are now under review by the Israeli Ministry of Health, and we expect to be cleared to initiate these trials in the first half of 2012.
"Moving forward, we are very excited about the opportunities for Medgenics' Biopump in a variety of therapeutic indications and look forward to continuing to advance our technology both through internal development and through collaborations," noted Dr. Pearlman.
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.
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
+44 207 398 7719
Religare Capital Markets (NOMAD)
James Pinner / Derek Crowhurst
+44 207 444 0800
SVS Securities plc (Joint Broker)
Alex Mattey / Ian Callaway
+44 207 638 5600
Nomura Code Securities (Joint Broker)
Jonathan Senior, +44 207 776 1219