OFAC Grants License Authorizing Importation into U.S. of Cuban Anti-Cancer Drug
YM BioSciences Inc., a Canadian company engaged in the acquisition, development and commercialization of oncology and acute care products, recently announced that the Treasury Department's Office of Foreign Assets Control (OFAC) has issued a specific license allowing YM BioSciences' wholly-owned U.S. subsidiary to import nimotuzumab into the U.S. for the purpose of conducting clinical trials in pediatric patients with pontine glioma.
Nimotuzumab is a monoclonal antibody that targets the Epidermal Growth Factor Receptor and was developed at the Center for Molecular Immunology affiliated with the University of Havana. As a result of the OFAC license, YM BioSciences said that it plans to submit an application to the U.S. Food and Drug Administration to allow the investigation of nimotuzumab for the treatment of children with intrinsic diffuse pontine glioma. According to the company, if FDA permission is granted it would be the first anti-cancer drug from Cuba to be used in clinical trials in the US.
Labels: OFAC