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YM BioSciences announces FDA clearance for two ongoing Phase II nimotuzumab trials into USA
Date:1/26/2010

ur data, which support the unique selectivity of nimotuzumab for the overexpressed receptors on tumor that uniquely permit it to discriminate between normal tissue and tumor EGFR, has heightened investigator interest in advancing nimotuzumab."

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 being conducted internationally. Patients diagnosed with Stage IIb or 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 in one third of the patients, and improvement of survival. Completed Phase I studies executed in Canada and Korea have demonstrated that nimotuzumab has the prospect of optimizing palliative care in this indication with initial stimulating results in this population. The primary objective of the trial is to evaluate the difference in Overall Survival between the arms with secondary endpoints being the differences in Time to Progression, Response Rate, Quality of Life, and Progression-Free Survival.

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.

Both trials are currently open in Canada and are being extended into Europe, Korea,

SOURCE YM BioSciences Inc.
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