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YM BIOSCIENCES REPORTS DAIICHI-SANKYO ENROLLS FIRST PATIENTS IN PHASE II, FIRST-LINE LUNG CANCER TRIAL WITH NIMOTUZUMAB
Date:6/23/2009

on a Phase I trial treating patients with palliative radiotherapy for NSCLC. The data from the Canadian arm of the trial were presented at ASCO 2008 and indicated that the combination of nimotuzumab with radiation was feasible and safe and has the potential to provide an important quality of life and survival advantage to patients over radiation alone in the palliative setting. Continued treatment for prolonged periods was very well tolerated and there was no evidence of Grade III or IV rash at any of the three dose levels nor did nimotuzumab increase the toxicity of radiotherapy. Based on these results, YM is currently conducting an international 128-patient Phase II randomized, double-blind, placebo-controlled study that will examine the effect of nimotuzumab when added to palliative radiotherapy to treat NSCLC. The incidence of NSCLC exceeds 367,000 new cases each year in the seven major pharmaceutical markets.

YM licensees Daiichi and Kuhnil are currently collaborating on a Phase II randomized, open-label trial they are conducting evaluating nimotuzumab plus irinotecan compared to irinotecan alone in patients with advanced or recurrent gastric cancer who are refractory to 5-FU-containing regimens. The licensees report enrollment continues to progress and remains on track to be completed in calendar 2009.

Results were reported recently at the 2009 ASCO Annual Meeting from a randomized Phase IIb, four-arm, open-label trial of nimotuzumab in combination with radiation therapy (RT) or chemoradiation therapy (CRT) in patients with inoperable, locoregionally advanced Stage III/IVa head and neck cancer conducted in India by Reddy BK et al. The addition of nimotuzumab to both the RT and CRT regimens improved the overall response rate, survival rate at 30 months, median progression-free survival and median overall survival. A combined group analysis of the nimotuzumab arms vs. the non-nimotuzumab arms demonstrated a significant difference in overall surv
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SOURCE YM BioSciences Inc.
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