Medgenics, Inc. has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, and is pleased to announce encouraging new results in the Company's ongoing Phase I/II clinical trial with our first product, the EPODURE Biopump, to treat anaemia. 

The trial is being conducted in Israel under approval of the Israeli Ministry of Health in consultation with the U.S. Food & Drug Administration (FDA). By maintaining hemoglobin levels in the target range for several months in several patients, our phase I/II clinical trial has demonstrated that a single administration of EPODURE Biopumps of appropriate dose can provide sustained anemia treatment for at least six months or more while alleviating the need for frequent EPO injections and thereby improving patient quality of life. As of February 2011, one of the earliest patients to receive treatment has shown sustained hemoglobin within the target range for more than 28 months following a single treatment by EPODURE Biopumps and without receiving any EPO injections in that period, whereas he had been under treatment by EPO injections prior to EPODURE treatment. By contrast, in standard practice today, EPO injections are required up to three times per week. We have also tested the use of the EPODURE Biopumps to administer the EPO mid-range dose of 40 IU/kg/day in our clinical trial and the EPO high-range dose of 60 IU/kg/day. To date we have treated 14 patients – six patients at the low dose level, seven patients at the mid-range dose level and one at the high-range dose – and shown evidence that the EPODURE Biopump can be administered in a dose dependent way. Based on the results at the low and mid-range doses, the Israeli Ministry of Health determined that it was safe to expand our phase I/II renal anemia study to include higher dose treatments and, consequently, the treatment of the first high-range dose patient occurred in January 2011.

We believe that the EPODURE Biopump has been demonstrating the ability of tissue Biopumps to provide safe and sustained protein therapy in patients, and are using the same Biopump Platform Technology to continue laboratory development of Biopumps producing additional proteins. We have demonstrated this in the laboratory and in animals with our next product, the INFRADURE Biopump which produces IFN-α to treat hepatitis C, and we are now planning to begin its clinical development. We have also developed the HEMODURE Biopump in the laboratory that makes blood clotting Factor VIII. We believe that the EPODURE clinical results and the laboratory results for the INFRADURE Biopump and HEMODURE Biopump demonstrate that our Biopump Platform Technology is capable of sustained continuous production of various therapeutic proteins.