YM BioSciences Inc, an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, has received clearance from Canadian regulatory authorities to initiate two phase-II, double-blind, randomized trials for nimotuzumab, its EGFR-targeting antibody, in combination with radiation-based treatments. The company will conduct a phase-II trial in approximately 128 patients with non-small cell lung cancer (NSCLC) and a phase-II trial in approximately 88 patients with brain metastases from NSCLC. Enrolment for both trials is expected to be initiated in Canada in the first quarter of calendar 2009 and YM anticipates adding sites from other countries into the trials.
"Conducting randomized, controlled studies in these particularly challenging and neglected patient populations will substantially augment the already extensive late-stage clinical program being pursued by the global consortium of companies developing nimotuzumab. The results from these trials could contribute significantly to the data package for nimotuzumab which will be used to expand its approval across international markets. Specific to our North American regulatory strategy, these trials form part of the registration program and should generate robust data relatively rapidly," said David Allan, chairman and CEO of YM BioSciences. "We have focused on cancers typically treated with radiation-containing regimens because the combination has demonstrated the potential to maximize the benefits of radiotherapy and increase survival and quality of life while avoiding the toxic side-effects of both chemotherapy/radiation combinations and the debilitating and dangerous side effects of other EGFR-targeting drugs."
"Numerous NSCLC patients undergo radiotherapy because they are unfit for radical chemoradiotherapy or require radiotherapy palliatively for their chest disease either as part of their initial management or after failing other treatments," said Dr Leonardo Viana Nicacio, director of Clinical Affairs for YM BioSciences. "Nimotuzumab combined with palliative radiotherapy is a rational step towards a better treatment regimen that is safe and has the prospect of improving survival in this population that has typically exhausted all other options."
"Approximately 25 per cent of all patients with lung cancer are expected to develop brain metastases. In recent studies, the median survival of patients with brain metastases, most of whom were treated with WBRT, has ranged from three to five months highlighting the desperate need for new therapies to address this indication," said Dr Leonardo Viana Nicacio. "In an ongoing exploratory study, nimotuzumab administered concurrently with WBRT has yielded meaningful clinical responses in similar late-stage patients. A randomized trial in this indication is a promising opportunity to demonstrate the efficacy of our EGFR-targeting drug and its best-in-class safety profile."
YM BioSciences is a company that identifies, develops and commercializes differentiated products principally in the area of oncology for patients worldwide.