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YM BIOSCIENCES REPORTS DAIICHI-SANKYO ENROLLS FIRST PATIENTS IN PHASE II, FIRST-LINE LUNG CANCER TRIAL WITH NIMOTUZUMAB
Tuesday, June 23, 2009 11:49 AM


MISSISSAUGA, ON, June 23 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported that its licensee for nimotuzumab, Daiichi-Sankyo Co., Ltd. in Japan advises that it has commenced enrollment of a Phase II trial evaluating nimotuzumab in combination with radiation therapy/cisplatin/vinorelbine in first-line curative intent patients with Stage III non-small-cell lung cancer (NSCLC). The trial will evaluate the treatment completion rate and numerous secondary endpoints including response rate, progression-free survival, and the overall survival rate at 12 and 18 months as well as toxicity.

'This is the latest of eleven Phase II and III trials currently being conducted by YM and/or its four licensees, highlighting the tremendous breadth of clinical activity focused on nimotuzumab and the benefits of our cooperative model which permits the undertaking of such a comprehensive international program,' said David Allan, Chairman and CEO of YM BioSciences. 'Of these trials, three involve patients with NSCLC at various stages - curative, palliative radiotherapy and metastatic. NSCLC is an important indication for nimotuzumab as treatments typically involve radiation-containing regimens that have been demonstrated to enhance the expression of EGFR. Nimotuzumab's differentiated mechanistic attributes result in it selectively targeting tissues over-expressing EGFR while avoiding normal tissue. The debilitating and dangerous side effects observed with the marketed EGFR-targeted drugs result from their indiscriminant targeting of normal healthy tissues in addition to their binding to tumor.'

YM and its licensee Kuhnil Pharmaceutical Co. in Korea recently collaborated 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.



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