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Medgenics on target to start Phase I/II clinical trials with EPODURE protein therapy for anaemia mid-2008 as planned

16 Apr 2008 - Medgenics provided an update on progress towards the start of its Phase I/II clinical trials with EPODURE, its lead sustained-action protein therapy for producing and delivering erythropoietin (EPO) to treat anaemia. The Company continues to make excellent progress with its preparations to commence Phase I/II trials of EPODURE and remains confident it will begin these trials by mid-2008 as planned. In addition, Medgenics expects to obtain the key initial safety and proof of efficacy data for EPODURE within 3-5 months after the trial commences.
 
Medgenics submitted its application for approval of the Phase I/II trials of its EPODURE protein therapy to the Israel Ministry of Health (MoH) in February 2008. The application is currently in active review by MoH and Medgenics anticipates that approval will be obtained in good time to enable the trials to commence mid-year. EPODURE is Medgenics' lead product in development, designed to provide a sustained-action protein therapy for producing and delivering EPO continuously for a period of 4-6 months or longer to treat anaemia in patients with chronic kidney disease.
 
The Phase I/II clinical trials are designed to generate key initial safety and proof of efficacy data for EPODURE, and are planned to take place at the Hadassah Hospital in Jerusalem, Israel. In September 2007, Medgenics received initial approval of its trial protocol from the Ethics Committee of Hadassah Hospital, conditional upon final approval from MoH.