YM BIOSCIENCES USA RECEIVES CLEARANCE FROM US TREASURY DEPARTMENT TO EXTEND CLINICAL PROGRAM FOR NIMOTUZUMAB
“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
Mr. Allan added, “We have also applied to OFAC for a license to make nimotuzumab available to US patients upon marketing approval by the FDA. This is consistent with a 2009 Staff Report to the US Senate Committee on Foreign Relations (SCFR) entitled ‘Changing Cuba Policy – In
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
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
About YM BioSciences
YM BioSciences Inc. is a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development. The Company is currently developing two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical trial expertise and a diversified business model designed to reduce risk while advancing clinical products toward international approval, marketing and commercialization.
This press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(R) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE YM BioSciences Inc.