The Office of Foreign Assets Control (OFAC) of the U.S. Treasury Department has approved a license that allows YM BioSciences’ wholly owned U.S. subsidiary to import nimotuzumab into the U.S. It can be used in clinical trials only and YM intends to conduct trials in pediatric patients with pontine glioma. Nimotuzumab is a Mab that targets the epidermal growth factor receptor and was developed at Cuba’s Center for Molecular Immunology affiliated with the University of Havana.
“Diffuse pontine glioma is an inoperable malignant brain cancer that only affects children and, furthermore, it is a treatment-resistant tumor, so that children currently suffering from it have few treatment options,” says David Allan, chairman and CEO. “With this license from OFAC, we propose to submit an IND to the FDA to investigate nimotuzumab, thus potentially allowing U.S. children access to the drug through a controlled clinical trial setting while collecting efficacy and safety data.”
Upon FDA granting permission for the IND to proceed nimotuzumab, to the knowledge of the company, this would be the first anticancer drug from Cuba to be used in clinical trials in the U.S.
The OFAC license is the first step toward preparing to initiate U.S. clinical trials, and provided that the FDA concurs with the design, a trial in diffuse intrinsic pontine glioma will be undertaken in numerous U.S. and Canadian hospitals, according to YM Biosciences.