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

this patient population," said Leonardo Viana Nicacio, M.D., Director of Clinical Affairs for YM BioSciences. "The data are now shown to be reproducible in three separate studies, all of which reported nimotuzumab's characteristically benign toxicity profile. While the chemoradiotherapy and radiotherapy protocols in BEST differ from those commonly used in North America and Europe, treatments were consistent between the arms allowing for an appropriate assessment of nimotuzumab's activity and efficacy. These data, which suggest activity and durability similar to other anti-EGFR antibodies in this population, support the intended initiation of Phase III trials in this patient population."

A total of 92 patients were enrolled in the BEST trial, of which 76 were considered evaluable. The trial was sponsored by Biocon Ltd., the licensee from CIMAB S.A. for nimotuzumab in India. A poster describing 30-month data from this trial was presented at the 2009 ASCO Annual Meeting and is entitled: "A Phase IIb 4-arm open-label randomized study to assess the safety and efficacy of h-R3 monoclonal antibody against EGFR in combination with chemoradiation therapy or radiation therapy in patients with advanced (Stage III or IVa) inoperable head and neck cancer", by Reddy BK et al. (Citation: J Clin Oncol 27:15s, 2009; Abstract No: 6041; Session: Head and Neck Cancer).

The data presented at ASCO demonstrated that the addition of nimotuzumab to both the radiation and chemoradiation regimens improved the overall response rate, survival rate at 30 months, median progression-free survival and median overall survival. An unplanned, retrospective, combined group analysis of the nimotuzumab arms vs. the non-nimotuzumab arms demonstrated a significant difference in overall survival (p=0.0018) favoring nimotuzumab. The addition of nimotuzumab did not add to the severe toxicities of either regimen, with no Grade 3-4 skin toxicities observed. The authors concluded that the
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