MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)-- <\/p>\n
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 Companys 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 Companys proposed U.S. Phase II clinical study evaluating the safety and efficacy of sustained erythropoietin (EPO) therapy delivered via the Companys EPODURE Biopump for the treatment of anemia in dialysis patients with end-stage renal disease (ESRD). <\/p>\n
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<\/a>. <\/p>\n EPODURE is an autologous dermal Biopump capable of the sustained secretion of therapeutic EPO in the body using a small tissue explant from the patients own skin. The EPODURE Biopump is subsequently implanted subcutaneously into the patient to provide continuous delivery of EPO. <\/p>\n 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 iswidely 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. <\/p>\n 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. <\/p>\n About Anemia <\/p>\n 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. <\/p>\n About the National Institutes of Health Recombinant DNA Advisory Committee <\/p>\n 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. <\/p>\n<\/p>\n The rest is here: MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)-- 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 Companys successful presentation of study findings during a meeting held on March 8, 2012 Continue reading
\nMedgenics Reports Positive Meeting With NIH Recombinant DNA Advisory Committee<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"