YM BioScience cleared for further nimotuzumab studies

Canada's YM BioSciences, an oncology company that identifies, develops and commercializes differentiated products, has received clearance from  the Canadian regulatory authorities to initiate two Phase II,  double-blind, randomized trials for nimotuzumab, its EGFR-targeting  antibody, in combination with radiation-based treatments. The company  will conduct a Phase II study in around 128 patients with non-small cell  lung cancer and one in about 88 patients with brain metastases from  NSCLC. Enrollment for both trials is expected to be initiated in Canada  in the first quarter of calendar 2009 and YM anticipates adding sites  from other countries into the trials.

"Conducting randomized, controlled studies in these particularly  challenging and neglected patient populations will substantially augment  the already extensive late-stage clinical program being pursued by the  global consortium of companies developing nimotuzumab. The results from  these trials could contribute significantly to the data package for  nimotuzumab which will be used to expand its approval across  international markets. Specific to our North American regulatory  strategy, these trials form part of the registration program and should  generate robust data relatively rapidly," said David Allan, chief  executive of the firm.