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YM BioSciences Reports Fiscal Second Quarter 2011 Operational and Financial Results
Date:2/10/2011

e, 47% achieved a minimum 50% decrease in palpable spleen size, qualifying for Clinical Improvement (CI) per IWG-MRT criteria. - CYT387 controlled constitutional symptoms in a significant percentage of patients (night sweats: 88%, bone pain 80%, pruritus: 92%, fever: 100%). - Of 42 subjects who were evaluable for anemia response, 50% had achieved CI as per IWG-MRT criteria. A 57% response rate was observed in transfusion-dependent patients. - Full enrollment of 140 patients into the trial is anticipated in calendar Q1 2011. To date, 111 patients have been enrolled into the study. The Company anticipates that an additional set of updated interim data will be reported in the second quarter of calendar 2011 and a full data set will be reported by the end of calendar 2011. The Company is also working towards completing in calendar 2011 any preclinical and manufacturing activities required to enable CYT387 to commence a Phase III pivotal trial in calendar Q1 2012.

Nimotuzumab:

- Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in Japan, previously initiated a randomized trial with nimotuzumab in second line gastric cancer, together with Kuhnil Pharma Co. Ltd., CIMYM's licensee in Korea. Data from this trial were presented in January 2011 at the ASCO Gastrointestinal Cancers Symposium and demonstrated an improvement in Progression Free Survival in a subset of patients whose tumors were EGFR-positive. Should Daiichi Sankyo indicate an interest in advancing nimotuzumab into a Phase III clinical trial in gastric cancer, it could initiate in calendar 2012 subject to achieving commercial-scale production. Daiichi Sankyo also launched a Phase II trial in first-line treatment of advanced NSCLC for which YM has been advised that recruitment has been completed, with data expected during the first half of calendar 2011. - Oncoscience AG (OSAG), CIMYM's licensee for Europe, has advised that data from a Phase III trial in adult glioma patients may be repor
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