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NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD & NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS
Date:6/1/2009

with two control arms. This design was employed to facilitate comparison with other studies despite potential differences in treatment between India and Western countries. Notwithstanding the limited size of the study the survival rate at 30 months for the CRT + nimotuzumab arm was statistically superior to CRT arm, and compares favorably with historical controls performed in Western countries (Brizel DM, Albers ME, Fisher SR, et al: Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med 338:1798-1804, 1998); (Adelstein DJ, Li Y, Adams GL, et al: An intergroup Phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol 21:92-98, 2003); (Calais G, Alfonsi M, Bardet E, et al: Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced stage oropharynx carcinoma. J Natl Cancer Inst 91:2081-2086, 1999).

"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. In the clinical setting, where the tumor cells rely on the EGFR pathway to repair cytotoxic damage, nimotuzumab reproduces the efficacy of the other EGFR inhibitors in the presence of an astonishingly benign safety profile. The toxicity/benefit correlation remains generally true for the marketed drugs in this class, however our findings demonstrate that the extension of this correlation to the entire class is unsubstantiated," added Dr.
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