YM BioSciences Inc., the cancer product development company, was established in Canada in 1994. Its lead drug, tesmilifene, is a small molecule chemopotentiator effective in enhancing all known classes of chemotherapies currently used to treat cancer.
YM BioSciences completed enrolment of its 700 patient pivotal trial of tesmilifene for the treatment of rapidly progressing metastatic and recurrent breast cancer in September 2005. The primary endpoint of overall survival is designed to confirm data from the first Phase III trial.
Data from the first Phase III trial were published in the Journal of Clinical Oncology, January 15, 2004, demonstrating a >50% increase in overall survival when tesmilifene was administered in combination with chemotherapy compared to chemotherapy alone.
Data from the Phase II trial respecting the combination of tesmilifene with chemotherapy in hormone refractory prostate cancer were published in the Journal of Urology on October 11, 2005.
In addition to tesmilifene, YM BioSciences is developing nimotuzumab, an anti-EGFr humanized monoclonal antibody, in a number of indications including glioma, head and neck, NSCLC, and pancreatic cancers. A Phase II monotherapy trial of nimotuzumab produced cytotoxic efficacy and evidence of survival benefit in children with brain cancer. YM BioSciences is also developing its anti-GnRH, anti-cancer vaccine, Norelin™, for which Phase II data have been released. The Company's subsidiary DELEX Therapeutics Inc., is developing AeroLEF™, a unique inhalation delivered formulation of the established drug, fentanyl, to treat acute pain including cancer pain. This product has completed a Phase IIa trial with positive results and a randomized Phase IIb pain trial was cleared to start in September 2005 The Company also has a broad portfolio of preclinical compounds shown to act as chemopotentiators while protecting normal cells.
