Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has received formal notification of recommendations from the National Institutes of Health (“NIH”) Recombinant DNA Advisory Committee (“RAC”) reflecting the Company’s successful presentation of study findings during a meeting held on March 8, 2012. Completion of the RAC process is an important step in advancing toward the Company’s proposed U.S. Phase II clinical study evaluating the safety and efficacy of sustained erythropoietin (“EPO”) therapy delivered via the Company’s EPODURE™ Biopump™ for the treatment of anemia in dialysis patients with end-stage renal disease (“ESRD”).
The RAC meeting was attended by an audience from the general public and was webcast live. An archive of this webcast is available at http://videocast.nih.gov/summary.asp?Live=11074.
EPODURE is an autologous dermal Biopump capable of the sustained secretion of therapeutic EPO in the body using a small tissue explant from the patient’s own skin. The EPODURE Biopump is subsequently implanted subcutaneously into the patient to provide continuous delivery of EPO.
“We are delighted that the RAC has given such positive responses regarding our proposed Phase II clinical protocol for EPODURE to treat ESRD and we have already addressed most of their recommendations in our study planning,” said Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. “Clinical trials involving recombinant DNA products intended to be conducted in the U.S. generally need to satisfy review by the RAC, which is widely recognized as a most thorough scientific and clinical review by leading experts in relevant areas. Key to this positive response was the safety and sustained clinical activity we showed from the EPODURE Phase I/II trial conducted in Israel. We believe the RAC recommendations can be incorporated into our proposed protocol without difficulty and will not pose any significant delay or expense. Following a positive pre-Investigational New Drug (“IND”) application meeting with the U.S. Food and Drug Administration (“FDA”) last fall, completion of the RAC process clears an important hurdle toward the successful submission of our IND application and is a significant step in implementing our clinical strategy.