“We have also initiated a Phase IIa EPODURE study in Israel to treat anemia in dialysis patients with end-stage renal disease ("ESRD"), and have recently presented early data from that study in a poster at the 2012 Kidney Week of the American Society of Nephrology. We continue preparations to initiate a Phase II clinical trial in the U.S. in early 2013 with EPODURE in ESRD patients on dialysis, as cleared by the FDA in May under an Investigational New Drug (“IND”) application. Our objective with this EPODURE study is to achieve recommended hemoglobin targets for months, while avoiding the risks of supraphysiologic EPO concentrations associated with injections of erythropoietin stimulating agents, It also has the potential to improve the logistics of anemia management in a range of settings, whether in the clinic, home or elsewhere, to the benefit of both patients and payors.
“We are in the process of performing a comprehensive pipeline review to assess clinical applications we believe could benefit from our versatile Biopump platform and to update our list of targeted indications that will maximize our business development prospects,” added Dr. Pearlman.
“We are very pleased to have strengthened Medgenics leadership with the addition of Dr. Sol Barer as Chairman of the Board, and to have bolstered our clinical team with the appointment of Dr. Marvin Garovoy as Chief Medical Officer,” concluded Dr. Pearlman.
Third Quarter Financial ResultsGross research and development (“R&D”) expense for the third quarter of 2012 increased to $1.89 million from $1.79 million for same period in 2011 due to an increase in R&D personnel. Net R&D expense for the 2012 third quarter was $1.61 million compared with net R&D expense of $1.35 million for the prior year’s third quarter. General and administrative expense for the third quarter of 2012 was $1.47 million compared with $1.88 million for the third quarter of 2011, primarily due to a decrease in compensation for professional services.