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: