Sponsored by
Monday, 25th September 2006 09:06
YM Bio gets clearance to import nimotuzumab for clinical research into US
LONDON (AFX) - YM BioSciences Inc, the developer of oncology and acute care products, said it received clearance from the US Treasury Department's Office of Foreign Assets Control (OFAC) to import nimotuzumab into the US for the purpose of clinical trials in pediatric patients with pontine glioma.
Nimotuzumab is a monoclonal antibody that targets the epidermal growth factor receptor.
YM said it will now file an Investigational New Drug (IND) application to the US Food & Drug Administration for permission to investigate nimotuzumab for the treatment of children with intrinsic diffuse pontine glioma, an inoperable malignant brain cancer that only affects children.
Nimotuzumab, which is currently approved in India, China, Argentina, and Columbia as well as Cuba, was recently licensed by YM to Daiichi Pharmaceutical Co for the Japanese market.
In Europe and Canada, the drug is in numerous clinical trials including non-small cell lung cancer, pediatric glioma and refractory
solid tumours. That latter study evaluated nimotuzumab as monotherapy and demonstrated significant clinical benefit in this highly refractory patient population, YM said.