YM BioSciences and Oncoscience Achieve Clinical Milestone
1/25/2005 Mississauga, Ontario, Canada press release Yahoo! Finance (biz.yahoo.com) Results Permit Pediatric Brain Cancer Trial to be Converted into Pivotal Randomized First-Line Therapy Trial YM BioSciences Inc. today announced that it has been advised by its European partner, Oncoscience AG, that the Phase II trial in children with brain cancer (glioma) utilizing the EGF receptor monoclonal antibody (h-R3) as a monotherapy achieved the clinical milestone that permits conversion of the trial into a pivotal trial in this population. The new study will be a randomized Phase III trial comparing radiation (the standard-of-care) to radiation plus h-R3 as a first-line therapy following surgery. YM has been advised that the trial is expected to enroll 100 patients and is targeted for completion in the second quarter of 2006. Results from the original trial will be formally presented at the "European High-Grade Glioma Meeting" on February 25-26, 2005 in Regensburg, Germany. "Although the results are preliminary in nature, we have been advised that at least three patients responded to the treatment, allowing the early conversion of the trial into a more significant pivotal trial. This is a welcome and unanticipated result in a patient population for whom no other therapy is available and prognosis is very poor," said David Allan, Chairman of YM BioSciences. The study is being conducted in Germany by YM's partner in Europe, Oncoscience AG, and is the first trial of this antibody as a monotherapy and its first trial in children. "Early termination of the trial for success in [...]