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YM BioSciences enrolls first US patient in Phase II randomized, double-blind brain metastases trial for nimotuzumab
Date:5/27/2010

YM BioSciences Inc. "The blinding of this trial is feasible because nimotuzumab does not produce the severe toxicities typical of the currently marketed EGFR class of antibodies, providing the potential for an improvement on brain mestastases control and survival with an important difference to the quality of life for patients. Access to nimotuzumab in the US was previously limited to pediatric patients and recruitment in a trial in inoperable brain cancer in that population was recently completed. Nimotuzumab continues to demonstrate efficacy both in clinical trials and in the numerous countries in which it is marketed without causing the severe toxicities, demonstrating the best-in-class prospect this drug holds that will now be available to adult US patients."

Brain metastases trial

This Phase II study, comparing nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC, has a target enrollment of 88 patients and is also being conducted internationally. The primary efficacy endpoint is the difference in intracranial disease progression over six months.

Palliative radiotherapy to intrathoracic disease from non-small cell lung cancer trial

This Phase II study, that is examining the effect of nimotuzumab when added to palliative radiotherapy to treat intrathoracic disease from NSCLC, has a target enrollment of 128 patients and is also being conducted internationally. Patients diagnosed with Stage III NSCLC ineligible for curative treatment, or Stage IV NSCLC patients with progressive disease within the chest, are eligible to enroll into this study. Palliative radiotherapy is effective for improvement of symptoms resulting from lung disease, improvement in quality of life, and improvement of survival. Completed Phase I studies executed in Canada and
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SOURCE YM BioSciences Inc.
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