YM BioSciences USA Receives Clearance from US Treasury Department to Extend Clinical Program for Nimotuzumab
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YM BioSciences Inc. has announced that its wholly-owned subsidiary, YM BioSciences USA Inc. has received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) to further develop its lead product, nimotuzumab, for patients with solid tumor cancers in the United States.
"This license from OFAC to develop nimotuzumab in any cancer indication is a major step forward in our US development program and will allow us to immediately discuss our IND submissions with the FDA to include US patients in our randomized, double-blinded lung cancer and brain metastases trials," said David Allan, Chairman and CEO of YM BioSciences.
He continued, "Our development plans may also include extending some of the Phase III trials being conducted worldwide into the US. There are quantifiable physical, emotional and financial costs that result from the numerous and severe toxicities of the currently available EGFR-targeting drugs which are not evident with the administration of our drug. Nimotuzumab has been demonstrating efficacy in trials throughout the world and we are very pleased that US patients will now have the opportunity to receive the drug and that a broader group of US oncologists will gain experience with it. Our goal is to bring this therapeutic option, already approved for marketing in 18 countries, to patients in the US as rapidly as possible."
YM USA previously received a license from OFAC to import nimotuzumab into the US to conduct a study of nimotuzumab in children suffering from recurrent diffuse intrinsic pontine glioma. This trial is ongoing at 10 of the principal oncology hospitals in the US and data is expected in 2010. Nimotuzumab is also available on a compassionate use basis in the US for children with this condition and is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of Molecular Immunology in Cuba. The drug has demonstrated efficacy in clinical trials without the serious side effects observed with the marketed EGFR-targeting drugs.
"This license from OFAC to develop nimotuzumab in any cancer indication is a major step forward in our US development program and will allow us to immediately discuss our IND submissions with the FDA to include US patients in our randomized, double-blinded lung cancer and brain metastases trials," said David Allan, Chairman and CEO of YM BioSciences.
He continued, "Our development plans may also include extending some of the Phase III trials being conducted worldwide into the US. There are quantifiable physical, emotional and financial costs that result from the numerous and severe toxicities of the currently available EGFR-targeting drugs which are not evident with the administration of our drug. Nimotuzumab has been demonstrating efficacy in trials throughout the world and we are very pleased that US patients will now have the opportunity to receive the drug and that a broader group of US oncologists will gain experience with it. Our goal is to bring this therapeutic option, already approved for marketing in 18 countries, to patients in the US as rapidly as possible."
YM USA previously received a license from OFAC to import nimotuzumab into the US to conduct a study of nimotuzumab in children suffering from recurrent diffuse intrinsic pontine glioma. This trial is ongoing at 10 of the principal oncology hospitals in the US and data is expected in 2010. Nimotuzumab is also available on a compassionate use basis in the US for children with this condition and is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of Molecular Immunology in Cuba. The drug has demonstrated efficacy in clinical trials without the serious side effects observed with the marketed EGFR-targeting drugs.
