“We look forward to submitting our IND to the FDA in the coming months and to obtaining FDA clearance for our Phase II clinical trial, which we expect will affirm the positive results from our earlier Phase I/II study of EPODURE in pre-dialysis patients,” added Dr. Pearlman. “In that study we demonstrated that a single administration can raise and maintain hemoglobin levels for many months without any injections of erythropoietin stimulating agents.”About Anemia Anemia is a common complication of renal failure resulting primarily from insufficient production of the hormone EPO by the damaged kidneys, which leads to a decrease in production of red blood cells. Treatment with EPO typically involves intravenous or subcutaneous administration by injection at regular intervals followed by frequent laboratory tests to monitor hemoglobin concentration. Due to the short half-life of the protein, it is usually administered at doses that result in super physiological levels, which then decline into a more physiologic range. This variability in levels, and in particular the peak levels which then decline into a more physiologic range. This variability in levels, and in particular the peak levels, has been hypothesized to potentially increase the risk of adverse cardiovascular effects and may make maintenance of steady hemoglobin levels more challenging. The need for frequent injections and laboratory tests, medication compliance and lifestyle adjustment are potential barriers to achieving the desired hemoglobin goal. These barriers, together with the high costs of the currently available recombinant EPO products, provide an incentive to improve care with a sustained therapy approach. About the National Institutes of Health Recombinant DNA Advisory Committee The objective of the Recombinant DNA Advisory Committee is to provide advice to the Director of the NIH on matters related to the conduct and oversight of research involving recombinant DNA, including the content and implementation of the NIH Guidelines for Research Involving Recombinant DNA Molecules and other NIH activities pertinent to recombinant DNA technology. The RAC comprises experts in a wide range of scientific and medical disciplines and also includes medical ethicists and members of patient and other lay communities. Because of the dedication, effort, and thoughtful contributions of its members over the past 30 years, the RAC has been a vital national forum promoting critically important scientific progress in a transparent, responsible, and safe manner and enhancing public trust in the science.
About MedgenicsMedgenics is developing and commercializing Biopump™, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics has three long-acting protein therapy products in development based on this technology:
- EPODURE (now completing a Phase I/II dose-ranging trial) to produce and deliver erythropoietin for many months from a single administration, has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for six to more than 36 months;
- INFRADURE TM (planning to commence a Phase I/II trial in Israel in 1H12 in hepatitis C) to produce a sustained therapeutic dose of interferon-alpha for use in the treatment of hepatitis;
- HEMODURE TM is a sustained Factor VIII therapy for the prophylactic treatment of hemophilia, now in development.