YM BioSciences Announces FDA Clearance for Phase II Nimotuzumab Trials into USA
News Jan 27, 2010
YM BioSciences Inc. announced that the FDA has advised the Company that it may now enroll patients at 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. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone.
The current trial designs were informed by previous trials with nimotuzumab in the same indications. Previous palliative data were presented at ASCO 2008 and brain metastases randomized data at EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics, 2008.
YM BioSciences announced on August 10, 2009 that its wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) that lifted the limitation on the development of nimotuzumab in the USA for patients with solid tumor cancers.
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, Singapore and India as well as the United States. Enrollment is targeted for completion toward the end of 2010.