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 reported that nimotuzumab has been approved for marketing in Mexico. YM BioSciences also announced that it has enrolled the first two patients in its randomized, double-blind trial evaluating nimotuzumab in patients with brain metastases from non-small-cell lung cancer (NSCLC).
"Mexico is the 21st country to have approved nimotuzumab for marketing and, while YM's license for major market territories for nimotuzumab does not include Mexico, this approval reflects the growing recognition throughout much of the world of the value to patients of our drug and the progress being made in its commercialization," said David Allan, Chairman and CEO of YM BioSciences. "As part of YM's registration strategy for nimotuzumab, we were also pleased to report the opening of this second of two randomized, double-blind trials that YM is conducting in Canada and which are both now being expanded internationally."
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of Molecular Immunology in Cuba. Nimotuzumab is approved in two of the countries in YM's territories. The drug has demonstrated efficacy in clinical trials without producing the numerous and severe toxicities observed with the other marketed EGFR-targeting drugs. Mexican regulatory authorities have approved nimotuzumab for the treatment of squamous cell carcinoma of the head and neck (SCCHN), adult glioma and pediatric glioma. The approval was granted to Laboratorios PiSA in Guadalajara, Mexico and nimotuzumab will be commercialized under the name VECTHIX(R).
First patients enrolled in multinational randomized, double-blind brain metastases trial
YM BioSciences recently enrolled and treated the first two patients in its multinational randomized, double-blind trial evaluating nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC. The trial is designed enroll approximately 88 patients over twelve months followed by a twelve-month follow-up period and will likely include 12 investigational centers in Canada plus additional centers in other countries. The patients were enrolled at the L'Hôpital Maisonneuve-Rosemont in Montreal, Canada.