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news.The FDA has advised YM BioSciences that it may now enroll patients at the US clinical sites into two ongoing randomized, double-blind phase II trials of its lead product, nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively, and the other in patients with brain metastases from NSCLC.
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YM BioSciences announced on August 10, 2009, that its wholly-owned subsidiary, YM BioSciences USA (YM-USA) received a license from the US Department of the Treasury’s Office of Foreign Assets Control (OFAC). OFAC had lifted the limitation on the development of nimotuzumab in the US for patients with solid tumor cancers.
David Allan, chairman and CEO of YM BioSciences, said: “Nimotuzumab has been demonstrating efficacy in trials throughout the world and this clearance from the FDA is an important milestone in our US development program. We are very pleased that US patients will now have the opportunity to receive nimotuzumab and that a broader group of US oncologists will gain experience with it.
“While the rarity of any of the severe toxicities generally attributed to this class of drug has been a challenge for the credibility of nimotuzumab’s efficacy, the growing recognition of our 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.”
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.
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, Singapore and India as well as the US. Enrollment is targeted for completion toward the end of 2010.