YM BioSciences OK'd to import nimotuzumab for U.S. research in pediatric brain cancer

By E. Janene Geiss

Philadelphia, Sept. 25 - YM BioSciences Inc. said Monday that the Office of Foreign Assets Control of the U.S. Treasury Department has approved a license that allows YM BioSciences' wholly owned U.S. subsidiary to import nimotuzumab into the United States for clinical trials in pediatric patients with pontine glioma, an inoperable malignant brain cancer that only affects children.

Nimotuzumab is a monoclonal antibody that targets the Epidermal Growth Factor Receptor (known as EGFR) and was developed at the Center for Molecular Immunology affiliated with the University of Havana, the Mississauga, Ont., biopharmaceutical company said in a news release.

As a result of the license, YM BioSciences said it plans to submit an Investigational New Drug application to the Food and Drug Administration to allow the investigation of nimotuzumab for the treatment of children with intrinsic diffuse pontine glioma.

Upon the FDA granting permission for the IND to proceed, nimotuzumab would be the first anticancer drug from Cuba to be used in clinical trials in the United States, officials said.

The license is an important step toward preparing to begin U.S. clinical trials. Nimotuzumab, which is 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 tumors.

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