WAYNE, Pa. and MISGAV, Israel, June 5, 2014 (GLOBE NEWSWIRE) -- Medgenics, Inc. (NYSE MKT:MDGN), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex-vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that the first patient has been enrolled in its Phase 1/2 clinical trial of MDGN-201 (EPODURE TM ).
The aim of the trial is to validate the potential of the Company's BioPump™ platform using a second generation vector, which was developed to enhance durability of the proposed therapeutic effect. The study will evaluate the potential of the updated platform to offer sustained production and delivery of erythropoietin (EPO) to treat anemia in dialysis patients with end-stage renal disease (ESRD) or chronic kidney disease (CKD).
"The initiation of this trial is a testament to the capabilities and dedication of the Medgenics Research and Development Group. Our goal in conducting this clinical trial is to validate the new BioPump platform using an updated protocol and second generation viral vector. While we expect to see the same advantages over other forms of protein replacement that we saw with the first generation vector, we also hope to see substantially sustained levels of protein production," commented Dr. Garry Neil, Global Head, Research and Development of Medgenics. "Treatment alternatives for EPO-dependent anemia patients are still needed, so we hope to demonstrate the BioPump's capability to produce physiologically relevant levels of autologous EPO in patients with CKD and ESRD. We also hope to validate the new platform as a delivery mechanism for multiple rare and orphan diseases. As part of this strategy, we expect to initiate several in vivo proof-of-concept studies in established mouse models in rare and orphan disease indications later this year."
About the Trial (MG-EP-RF-02)
The trial will enroll up to 18 patients with either CKD or ESRD who require erythropoietin treatment for anemia. Each patient will receive one or more BioPumps and will be followed for at least one year. The trial endpoints include plasma erythropoietin levels, blood counts and safety assessment. Preliminary results are expected by the end of 2014. Additional details may be found on www.clinicaltrials.gov using identifier NCT02117427.
About Chronic Kidney Disease and End-stage Renal Disease
CKD is a progressive loss of kidney function over months to years. The three most common causes of CKD are diabetes mellitus, hypertension and glomerulonephritis. ESRD is also known as Stage 5 CKD. ESRD requires kidney replacement therapy, either dialysis or kidney transplantation.
About Medgenics, Inc.
Medgenics is developing and commercializing BioPump™, a proprietary platform for the sustained production and delivery of therapeutic proteins using ex-vivo gene therapy and the patient's own tissue for the treatment of orphan and rare diseases. For more information, visit the Company's website at www.medgenics.com .
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.
Medgenics, Inc. John Leaman Brian Piper Stern Investor Relations Beth DelGiacco 212-362-1200
