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YM BioSciences’ Nimotuzumab Demonstrates Efficacy In Randomized Head & Neck Cancer

YM BioSciences has declared the results from a randomized trial of nimotuzumab (BIOMAb/TheraCIM/h-R3) in patients with inoperable, locoregionally advanced Stage III/IVa head and neck cancer. The trial demonstrates the efficacy of nimotuzumab compares favorably to results reported for cetuximab, an EGFR-targeting antibody marketed as Erbitux.

However, this efficacy was not accompanied by the severe toxicities reported in patients treated with cetuximab. The results further conclude that this trial challenges the adopted tenet that the efficacy of EGFR inhibitors is linked to the toxicity of the class.

David Allan, Chairman and CEO of YM BioSciences, said: These data are further evidence of the unsupported extrapolation to the class of the toxicity/benefit correlation in the marketed EGFR drugs. The trial data demonstrate that patients have the prospect of equivalent clinical benefit from nimotuzumab as from the rest of the class without the physical, emotional and financial costs that result from the numerous and severe toxicities of Erbitux which are a consequence of the demonstrable inability of that drug to discriminate between healthy cells and tumor cells,

We expect that, as the numerous randomized trials currently ongoing worldwide with nimotuzumab report, the evidence for this claim will become increasingly robust, he added.

Leonardo Viana Nicacio, Director, clinical affairs for YM BioSciences said:The data from the Reddy BK et al proof-of-concept study clinically support the mechanistic attributes of nimotuzumab recently made public for the first time (Tikhomirov et al, AACR Meeting Abstract (2008) 2008: A36), that account for nimotuzumab having the prospect for the widest therapeutic window in its class. Nimotuzumab’s unique density-selectivity causes it to target the higher density of EGFR found in tumor cells while avoiding the lower density of EGFR in the cells of skin, kidney and gut.”