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news.YM BioSciences, a drug development company, has decided to terminate two randomized, Phase II, double-blind trials of nimotuzumab in North America due to slow rates of patient accrual and the projected timelines and costs anticipated to complete the studies.
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Nimotuzumab, a humanized monoclonal antibody targeting EGFR, is indicated for the patients with brain metastasis from non-small cell lung cancer (NSCLC) and palliative treatment of NSCLC.
YM BioSciences said the clinical impression of nimotuzumab continues to reflect favorably upon the drug’s safety and efficacy profile.
Once subjects have transitioned from these studies they will be eligible to continue receiving nimotuzumab through an ongoing Special Access Program (SAP) available in Canada.
The company’s Phase II, second-line, single-arm study in children with progressive diffuse intrinsic pontine glioma (DIPG) has concluded recruitment at multiple sites in the US, Canada, and Israel.
The company anticipates reporting results in calendar Q3 2011.
YM BioSciences said it will continue to work to secure a license from the US Department of the Treasury’s Office of Foreign Assets Control (OFAC) to commercialize nimotuzumab in the US.
Additionally, the company has concluded the scale-up and process development activities in connection with the manufacturing of nimotuzumab.
YM BioSciences expects to produce nimotuzumab in its newly started cGMP manufacturing facility in Havana, Cuba.