CuraGen Corp. (CRGN) announced that its Phase II Trial evaluating CR011-vcMMAE for the treatment of patients with unresectable Stage III or Stage IV melanoma met the efficacy criteria for advancement to the second stage of enrollment. CR011-vcMMAE is an antibody-drug conjugate comprised of a fully- human monoclonal antibody against glycoprotein NMB attached to a potent, synthetic drug monomethyl auristatin.
According to the company, out of the first six evaluable patients in the Phase II trial, one patient has had a confirmed objective response, as measured by RECIST criteria. As part of the Simon 2-Stage design the trial would be expanded to enroll 32 patients with a primary endpoint of objective response rate.
Further, the company expects enrollment in the study to complete by the end of 2008.
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