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YM BIOSCIENCES REPORTS POSITIVE NIMOTUZUMAB FOUR-YEAR SURVIVAL DATA PRESENTED AT ASTRO 2009
Date:11/2/2009

angalore, India described that the addition of nimotuzumab to radiotherapy (RT) and chemoradiotherapy (CRT) had an important effect on overall survival. At 48 months, 41% of the patients in the nimotuzumab+CRT arm were alive compared to 21% in CRT-alone arm, and 34.7% in the nimotuzumab+RT arm were alive compared to 13% in the RT-alone arm. The difference at 48 months between CRT and nimotuzumab+CRT arms reached statistical significance (p=0.0149). Kaplan-Meier curves for survival maintained a consistent separation at the 48-month update, demonstrating that the benefit of adding a fixed course of nimotuzumab to RT and CRT persists for an extended period. Because efficacy results in the control groups in this trial were similar to those published in contemporaneous international trials in this indication, and because imbalances between the study arms were minor, authors concluded that the benefit presented in this proof of principle trial must be attributable to the activity of nimotuzumab.

The trial contained no reports of late toxicity with nimotuzumab and its benign side-effect profile continued to be demonstrated. The combination of nimotuzumab with radiotherapy and chemoradiotherapy was safe and nimotuzumab did not potentiate radiation dermatitis. As a consequence, continuing reports concerning cetuximab and its significant potentiation of severe radiation dermatitis in the treatment of head and neck cancer with radiation continues to differentiate nimotuzumab which, as first described in a poster at AACR 2009, binds selectivity to cancer tissues thereby avoiding exacerbation of damage to healthy tissues by radiation.

"This trial adds to the body of clinical data concerning the activity of nimotuzumab in head and neck cancer, which includes a number of earlier trials. The presentation at ASTRO 2009 adds an important level of understanding for nimotuzumab's development highlighting its prospect to be the best anti-EGFR monoclonal antibody in
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SOURCE YM BioSciences Inc.
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