YM BioSciences (YM) 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 US.
Nimotuzumab has demonstrated efficacy in clinical trials without the serious side effects observed with the marketed EGFR-targeting drugs.
David Allan, chairman and CEO of YM BioSciences, said: 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.
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, he added.