MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--Medgenics, Inc. (NYSE MKT: MDGN)(AIM: MEDU)(AIM: MEDG) (the “Company”), developer of the novel Biopump™ technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the U.S. Food and Drug Administration (“FDA” or the “Agency”) to proceed with a Phase IIb clinical trial of EPODURE™ for the treatment of anemia in patients undergoing renal dialysis. EPODURE is intended to produce and deliver erythropoietin (“EPO”) on a sustained basis. This multi-center, randomized clinical trial will be the first study in the U.S. using the Company’s proprietary Biopump™ technology, and will evaluate the safety and efficacy of sustained EPO therapy delivered via Medgenics' EPODURE Biopump. Treatment of anemia in dialysis patients with EPODURE is intended to replace frequent injections of EPO or other erythropoietic stimulating agents (“ESAs”).
“This timely acceptance of our first Investigational New Drug (“IND”) to the FDA marks a significant milestone for our Biopump protein platform. We are very pleased with our U.S. regulatory progress and with the interactions with the FDA, allowing us to proceed with the launch of our first U.S. trial,” stated Andrew L. Pearlman, Ph.D., Chief Executive Officer of Medgenics. “This trial is significant for Medgenics as a company as well as for patients with anemia, as we anticipate EPODURE could provide a better treatment for anemia in the future.”
“We are hopeful that the positive interaction with the FDA for EPODURE bodes well for the Agency’s approach to other future indications for our Biopump protein delivery platform technology,” added Dr. Pearlman.
The FDA cleared the Phase IIb study protocol based on results from the Company’s prior Phase I/II anemia study of EPODURE in Israel, which reported safety and maintenance of hemoglobin for months from a single EPODURE treatment in pre-dialysis patients without requiring injections of EPO or ESAs, as well as on the complete preclinical package. The Company was particularly encouraged that clearance was received within the 30-day required regulatory response period from submission of the IND application and without major issues being raised. Medgenics views this as an early, second validation from an independent critical review in the U.S. of its Biopump platform. The Company announced in March that the National Institutes of Health’s Recombinant DNA Advisory Committee had given positive responses to the Company’s prior scientific and clinical data and its proposed Phase IIb study protocol.
The Company believes EPODURE has the potential to revolutionize the treatment of anemia by stabilizing hemoglobin levels within a safe range. This approach is designed to keep serum EPO levels within their normal physiological range and avoid excessive levels resulting from bolus EPO injections. This could be important in improving safety and addressing market concerns about the effects of excessive levels of EPO used in the treatment of anemia.
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, has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for six to more than 36 months in a Phase I/II dose-ranging trial, and has received approval of a Phase IIa trial in dialysis patients due to launch in Q2 2012 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 two Phase I/II trials in Israel in hepatitis C, slated to commence in Q3 2012, and is filed for Orphan Drug Designation with the FDA to treat 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.