Ceregene proceeds with new study on Parkinson's Disease
Monday, May 03, 2010 12:00 IST
San Diego, California
Ceregene, Inc, a biopharmaceutical company has announced that enrolment is proceeding in a new phase-1/2 clinical study evaluating CERE-120, a gene therapy product which delivers the neurotrophic factor neurturin, to dying neurons in Parkinson's Disease patients. This new clinical study follows a completed phase-2 trial and builds on experience gained in that trial, by enhancing the dosing regimen and optimizing the duration of patient follow up.
The new study was initiated in the fourth quarter of 2009 and is proceeding as planned. The ongoing phase-1/2 trial will enroll six patients with advanced Parkinson's Disease. The first four patients have been treated safely and two additional patients will be treated over the next two months. This phase-1 open label portion of the trial is being conducted by Dr Mark Stacy and Dr Dennis Turner at Duke University School of Medicine, Dr Michele Tagliati and Dr Ron Alterman at Mount Sinai Medical Center, New York, and Dr Stewart Factor and Dr Nicholas Boulis at Emory University Hospital. Ceregene expects to initiate the next phase of this trial (a sham-surgery-controlled, double-blind phase-2 portion) beginning during the third quarter of this year. The phase-2 portion will include 10 leading US neurological medical centers.
The first phase-2 clinical trial of CERE-120 initially reported in November 2008, did not meet its predesignated primary endpoint (UPDRS or Unified Parkinson's Disease Rating Scale- Motor Off, at 12 months) although modest benefit was seen in improving motor performance in Parkinson's disease patients, based on several secondary endpoints. Even greater improvement was seen following an analysis of all patients who were assessed under blinded conditions at 15 to 18 months post-treatment, including on the primary measure (UPDRS motor off [p=0.025] at 18 months).
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