MISSISSAUGA, ON, Jan. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Alternext US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that it has received clearance from 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 trial in approximately 128 patients with non-small cell lung cancer (NSCLC) and a Phase II trial in approximately 88 patients with brain metastases from NSCLC. Enrolment 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, Chairman and CEO of YM BioSciences. "We have focused on cancers typically treated with radiation-containing regimens because the combination has demonstrated the potential to maximize the benefits of radiotherapy and increase survival and quality of life while avoiding the toxic side-effects of both chemotherapy/radiation combinations and the debilitating and dangerous side effects of other EGFR-targeting drugs."
Non-small cell lung cancer trial
This randomized, double-blind, Phase II study will evaluate nimot
|SOURCE YM BioSciences Inc.|
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