MISSISSAUGA, ON, Aug. 10 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today announced that its wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) has received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) to further develop its lead product, nimotuzumab, for patients with solid tumor cancers in the United States.

"This license from OFAC to develop nimotuzumab in any cancer indication is a major step forward in our US development program and will allow us to immediately discuss our IND submissions with the FDA to include US patients in our randomized, double-blinded lung cancer and brain metastases trials," said David Allan, Chairman and CEO of YM BioSciences. "Our development plans may also include extending some of the Phase III trials being conducted worldwide into the US. There are quantifiable physical, emotional and financial costs that result from the numerous and severe toxicities of the currently available EGFR-targeting drugs which are not evident with the administration of our drug. Nimotuzumab has been demonstrating efficacy in trials throughout the world and we are very pleased that US patients will now have the opportunity to receive the drug and that a broader group of US oncologists will gain experience with it. Our goal is to bring this therapeutic option, already approved for marketing in 18 countries, to patients in the US as rapidly as possible."

Mr. Allan added, "We have also applied to OFAC for a license to make nimotuzumab available to US patients upon marketing approval by the FDA. This is consistent with a 2009 Staff Report to the US Senate Committee on Foreign Relations (SCFR) entitled 'Changing Cuba Policy - In the United States' National Interest,' which recommended pharmaceutical imports from Cuba's rapidly developing biotech industry. We are most appreciative of the extensive support we have received for our application from SCFR Chairman Senator John Kerry (D-MA), Western Hemisphere Subcommittee Chairman Senator Chris Dodd (D-CT) and SCFR Ranking Member Senator Richard Lugar (R-IN) and for their acute understanding of the needs of cancer patients. Such licenses have been previously granted to two companies seeking to commercialize Cuban-origin therapeutics in the US and we have ongoing discussions with OFAC in this regard."

YM USA previously received a license from OFAC to import nimotuzumab into the US to conduct a study of nimotuzumab in children suffering from recurrent diffuse intrinsic pontine glioma. This trial is ongoing at 10 of the principal oncology hospitals in the US and data is expected in 2010.