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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

ence reached statistical significance (p= 0.0039, Log Rank test).

About nimotuzumab

Nimotuzumab is currently being advanced in several randomized Phase II and III trials in Japan, South East Asia, Europe and elsewhere and is undergoing a YM-sponsored confirmatory trial in pediatric glioma in Canada and the US. The National Cancer Centre of Singapore (NCCS) recently announced that it has selected nimotuzumab for evaluation in the adjuvant setting in a multinational Phase III trial of more than 700 patients with cancers of the head and neck. The NCCS stated that it selected nimotuzumab because of its reported preferential safety profile compared with other EGFR-targeting cancer drugs.

Nimotuzumab is being developed to compete as best-in-class therapy against the currently marketed EGFR-targeting drugs. This drug has displayed efficacy in numerous tumour types (published and presented at major conferences including ASCO), having completed more than 27 clinical trials and having demonstrated anti-cancer activity that rivals the other EGFR-targeting antibody drugs.

In none of the clinical trials of nimotuzumab to date, to YM's knowledge, have any of the patients developed Grade III/IV acneiform rash, also a severe and dose-limiting side-effect observed in all of the other antibodies and with small molecules targeting the EGF tyrosine kinase signaling pathway. Unrelated to the rash, Grade III/IV radiation dermatitis is a severe toxicity reported in almost half the patients treated with another EGFR-targeting antibody drug in combination with radiation in head and neck cancer while absent in nimotuzumab/radiation treated patients. Reports of any severe incidents of the other side-effects that are typical of EGFR-targeting molecules have been rare. These severe side-effects can result in treatment interruptions, one of the leading causes of treatment failure and, unlike cetuximab, nimotuzumab patients do not have to be pre-m
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SOURCE YM BioSciences Inc.
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