www.fdanews.com/articles/67928-ym-biosciences-oncoscience-achieve-clinical-milestone
YM BioSciences, Oncoscience Achieve Clinical Milestone
January 25, 2005
YM BioSciences 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.