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YM BIOSCIENCES RECEIVES CLEARANCE TO INITIATE RANDOMIZED DOUBLE-BLIND CLINICAL TRIALS OF NIMOTUZUMAB IN LUNG CANCER AND BRAIN METASTASES FROM LUNG CANCER
Date:1/5/2009

uzumab's survival benefit in combination with external radiotherapy in patients diagnosed with stage IIb, III NSCLC who are ineligible for treatment with radical chemoradiotherapy or in stage IV NSCLC patients with chest disease including those eligible for palliative radiotherapy. The trial will enroll approximately 128 patients over 18 months followed by an 18 month follow-up period and will likely include 20 investigational centers in Canada plus additional centers in other countries. Nimotuzumab will be administered weekly, starting on the first day of radiotherapy, until disease progression. Chemotherapy may be provided to patients in either arm at the discretion of the physician.

The design of the trial was supported by data presented at ASCO 2008 from the Canadian arm of a fully recruited lead-in Phase I trial treating patients with NSCLC palliatively. That trial was conducted in Canada by YM and in Korea by Kuhnil Pharmaceutical Co. The ASCO data indicated that the combination of nimotuzumab with radiation has the potential to provide an important quality of life and survival advantage to patients over radiation alone in the palliative setting. Substantial radiological responses and meaningful clinical responses were seen inside and outside the radiation field in patients treated with the combination of nimotuzumab and radiation. 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. The Canadian cohort had a median survival of 13.8 months, which compares very favorably with historical data (Brundage Can J Oncol. 1996 Feb; 6 Suppl 1:25-32.; Bezjak Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):719-28; Sundstrom J Clin Oncol. 2004 Mar 1;22(5):801-10).

"Numerous NSCLC patients undergo radiotherapy because they are unfit for radical chemoradiotherapy or require radiotherapy palliatively for their chest disease either as part of their initial management
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SOURCE YM BioSciences Inc.
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