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YM BIOSCIENCES USA RECEIVES CLEARANCE FROM US TREASURY DEPARTMENT TO EXTEND CLINICAL PROGRAM FOR NIMOTUZUMAB
Date:8/10/2009

titled 'Changing Cuba Policy - In the United States' National Interest,' which recommended pharmaceutical imports from Cuba's rapidly developing biotech industry. We are most appreciative of the extensive support we have received for our application from SCFR Chairman Senator John Kerry (D-MA), Western Hemisphere Subcommittee Chairman Senator Chris Dodd (D-CT) and SCFR Ranking Member Senator Richard Lugar (R-IN) and for their acute understanding of the needs of cancer patients. Such licenses have been previously granted to two companies seeking to commercialize Cuban-origin therapeutics in the US and we have ongoing discussions with OFAC in this regard."

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. Nimotuzumab has been administered to approximately 5,000 patients worldwide and is currently in 32 trials internationally of which 11 are being conducted by YM and its four licensees. Three of the latter are Phase III trials, including one being conducted by the internationally recognized National Cancer Center of Singapore, which selected nimotuzumab over the alternative antibodies because of its benign side effect profile.


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