YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), 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 (Abstract 3037, Bebb, G) and brain metastases randomized data at EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics, 2008 (Poster 505, Macias, A).

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.

"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," said David Allan, Chairman & CEO of YM BioSciences Inc. "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."

Source: YM BIOSCIENCES INC.