|Novel Gene therapy shows promise for advanced Parkinson's. Amylin halts obesity drug study|
|By Mary Davila|
|Wednesday, 16 March 2011 22:58|
Neurologix, Inc. (OTC Bulletin Board:NRGX.ob), reported today that a mid-stage trial for patients with advanced Parkinson's disease (PD) was shown to reduce symptoms using gene therapy. The company announced that the results of the company's Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 were published in an online-first edition of The Lancet Neurology. The randomized, double-blind, sham surgery-controlled trial of 45 subjects with advanced PD met its primary outcome measurement for efficacy and demonstrated that NLX-P101 gene therapy was safe and well-tolerated over the six month blinded study period.
"This is the first Phase 2 study conducted under a rigorous randomized, double-blind, sham-controlled surgical design to conclusively demonstrate that gene therapy can be effective for neurological diseases. This confirms our Phase I results and indicates that NLX-P101 may provide a safe, effective and minimally invasive treatment option for patients with PD," noted senior author and co-principal investigator Andrew Feigin, M.D. of The Feinstein Institute for Medical Research at North Shore – LIJ Health System in Manhasset, New York
Study subjects were randomized to receive either NLX-P101 treatment or sham surgery. Subjects in the NLX-P101 treatment arm received infusions of the genetic material directly into bilateral subthalamic nuclei (STN), a key brain region involved in motor function. NLX-P101 aims to reset the overactive brain cells in the STN to inhibit electrical activity and return brain network activity to more normal levels. In PD, the loss of dopamine-secreting neurons alters chemical signaling pathways in the brain such that input to the STN is altered.
Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) and Takeda Pharmaceutical Company Limited (TSE:4502.to) today announced that they have suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of the investigational combination therapy pramlintide/metreleptin for the treatment of obesity. The clinical study was voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.
Covidien plc (NYSE:COV) today announced that Richard J. Meelia will retire as President and Chief Executive Officer of the Company, effective July 1. Mr. Meelia will serve as Non-Executive Chairman of the Board for a transition period of up to one year following his retirement as CEO.
The Board also announced that Jose (Joe) E. Almeida, President of Covidien’s Medical Devices business segment, has been elected to succeed Mr. Meelia as President and Chief Executive Officer.
Fibrocell Science, Inc. (OTCBB:FCSC.ob), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted a final study report to the U.S. Food & Drug Administration (FDA) for a completed, six-month histological study examining skin after injections of azficel-T. This study was a requirement in the Complete Response (CR) letter issued by FDA regarding the Company’s Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles. In December of 2010, the Company submitted data from a three-month assessment for this study. The Company has a PDUFA action date of June 22, 2011 for this BLA.
Human Genome Sciences, Inc. (Nasdaq:HGSI) and FivePrime Therapeutics, Inc. announced today that they have entered into an agreement to develop and commercialize FivePrime’s FP-1039 product for multiple cancers. FP-1039 is a first-in-class biologic discovered by FivePrime that targets multiple fibroblast growth factor (FGF) ligands. Under the terms of the agreement, HGS has acquired rights to develop and commercialize FP-1039 in the United States, Canada and the EU markets, while FivePrime retains minority co-promotion rights in the U.S. and full development and commercialization rights in rest of world territories, including Asia.
RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board:RGRX.ob) announced that it has received a notice from the FDA indicating that, due to non-compliance with FDA’s current Good Manufacturing Practice regulations by its contract manufacturer, the Company’s Phase 2 clinical trial of RGN-352, its injectable formulation of Thymosin beta 4 for the treatment of acute myocardial infarction (AMI), has been placed on clinical hold. RegeneRx is currently unable to estimate the length of time that the trial will be on clinical hold.
ULURU Inc. (NYSE Amex: ULU) announced today that it has filed an abbreviated 510(k) application with the U.S. Food and Drug Administration to expand Altrazeal®'s label claim to include the management and mitigation of pain.
eDiets.com, Inc. (NASDAQ: DIET), a leading provider of convenient at-home diet, fitness and healthy lifestyle solutions, will announce financial results for the fourth quarter and full year ended December 31, 2010, on Wednesday, March 30, 2011, after the market close. The Company will hold a conference call to discuss the results the same day.