Medarex Inc. (NASDAQ:MEDX) of Princeton, N.J., said Mondaythat a research team from Dartmouth Medical School has filedan investigational new drug (IND) application with FDA for adose-escalating Phase I/II clinical trial of a novel Bispecificantibody-based therapeutic for patients with advanced breastor ovarian cancer.
The Bispecific antibody that will be evaluated consists of anantibody, which binds to the HER-2 protein on the surface ofbreast and ovarian tumors, linked to Medarex's patentedTrigger antibody, which targets the Fc receptor found onmacrophages, monocytes and activated neutrophils.
The trial will be used to determine the safety and optimalbiological dose of the Bispecific antibody-based therapeutic. Itwill involve about 40 patients who have demonstratedresistance to conventional treatment for breast and ovariancancer, Medarex said.
Approximately 120,000 women are diagnosed with breastcancer each year, and ovarian cancer, the leading cause ofdeath among cancers of the female reproductive system in theU.S., was responsible for more than 12,500 deaths last year.
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