CuraGen’s melanoma drug shows positive activity

Results from the ongoing trial suggest the CR011-vcMMAE is well-tolerated at doses up through 1.88 mg/kg with no dose-limiting toxicities noted. Dose- escalation continues with patients currently being enrolled into the 2.63mg/kg cohort. Of the 25 patients treated with doses ranging from 0.03mg/kg to 1.88mg/kg, six patients achieved stable disease lasting up to 11 cycles, and four of the six patients demonstrated tumor shrinkage of up to 20%.

Reversible neutropenia was the only drug-related Grade 3 or 4 adverse event, and appears to be dose-dependent. Evaluation of the pharmacokinetic results also suggest that CR011-vcMMAE can be given safely to achieve human plasma concentrations in the anticipated range of activity based on data from in vivo xenograft animal models.

Dr Mario Sznol, co-principal investigator and co-director of the melanoma program at the Yale Cancer Center in New Haven, said: “We are encouraged by these initial clinical results on CR011-vcMMAE and the suggestion of potential anticancer activity in patients with previously progressive disease, which support continued evaluation of this antibody-drug conjugate in the treatment of advanced melanoma. We continue to enroll patients into the trial, and look forward to further characterizing the activity of this novel therapeutic.”