Medgenics’ phase I/II clinical trial shows EPODURE continuous anemia treatment lasting 5 months in kidney disease patients

Mar 29 2009

Medgenics has announced that the latest, encouraging results of the Company's ongoing EPODURE Biopump Phase I/II Clinical Trial were presented at the 45th Conference of the Israeli Society of Nephrology and Hypertension, in Israel on March 27, 2009.

The latest results of the trial show that in the first 2 of the patients treated, the hemoglobin level has now remained continuously in the target range of 10-12 g/dl for more than 5 months following a single EPODURE treatment using the lowest dose of 20 IU/kg/day, thus effectively treating their anemia without receiving any injections of erythropoietin (EPO) during this period. One of the patients received his last EPO injection more than 200 days ago. This is contrasted with the FDA approved standard regimen of thrice weekly EPO injections, in which typical patients would expect to receive up to 85 injections in this timeframe.

A total of 7 patients have now been treated, with 6 patients receiving treatment for more than one month. The seventh patient is the first to receive the higher dose of 40 IU/kg/day, which is double that of the lowest dosage, and the higher dose treatment is proceeding smoothly. There continue to be no adverse events reported in the study. Patient recruitment continues for the higher dose treatment.

The new data will be presented at the conference by Dr. Michal Dranitzki Elhalel, the principal nephrologist of Medgenics' EPODURE Phase I/II clinical trial, currently taking place at the Hadassah Hebrew University Hospital in Jerusalem, Israel.

The trial's sponsors and Principal Investigators are now seeking approval to broaden the study to include dialysis patients as well as pre-dialysis patients. More information on this will be announced as developments proceed.

The Company's active discussions with major potential strategic partners have expanded since the announcement in February, with additional companies having expressed interest in one or more applications.

Medgenics, Inc. is a clinical-stage biopharmaceutical company developing its unique tissue-based Biopump platform technology to provide sustained-action protein therapy for the treatment of a range of chronic diseases.

Medgenics currently has two products in development based on this technology:

• EPODURE – producing erythropoietin (EPO) to treat anemia
• INFRADURE – producing interferon-alpha (IFN-á) to treat Hepatitis-C

The Company's ongoing Phase I/II clinical trial for EPODURE in anemic patients continues to demonstrate proof of concept of the Biopump. Designed to produce and deliver a therapeutic dose of EPO steadily for up to six months or more, EPODURE Biopumps are already maintaining effective anemia treatment for more than 5 months in earliest patients in the ongoing study, even with low dose administered.

Medgenics intends to develop its innovative products and bring them to market via multiple strategic partnerships with major pharmaceutical and/or medical device companies, starting with EPODURE and INFRADURE.

Medgenics plans to raise the requisite funds during 2009 to enable it to follow the current trial of EPODURE with a Phase IIb clinical trial in the US starting in 2010, and in addition, to commence a Phase I/II trial of INFRADURE in Hepatitis-C patients in Israel also during 2010.

Beyond these, 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 US $87 billion by 2010. Other potential areas include multiple sclerosis (interferon-beta), hemophilia (Factor VIII), pediatric growth hormone deficiency (human growth hormone) and diabetes (insulin).