CuraGen reports encouraging preliminary data from Phase II melanoma trial

Approximately 36 patients were enrolled into this Phase II open-label, multi-center trial that is evaluating the efficacy and safety of CR011-vcMMAE 1.88mg/kg administered intravenously once every three weeks. Eligible patients had progressive disease at trial entry and may have received one prior cytotoxic regimen and any number of prior immunotherapies. Of the patients enrolled, 94% had stage IV disease of which two-thirds were classified as M1c, the poorest risk group.

At the time of the data cutoff for this analysis, 31 patients had at least one efficacy assessment available, and 18 patients were continuing to receive ongoing treatment in the study. The median overall progression-free survival (PFS) to date was approximately 4.5 months. Recist-defined partial responses were reported in three patients, two ongoing, and an unconfirmed partial response in one patient. Approximately 19 patients had stable disease, 14 ongoing, with tumor shrinkage observed in 12 of these patients.

CuraGen is currently enrolling patients into a Phase I portion of this trial to evaluate more frequent dosing schedules of CR011-vcMMAE, including a weekly and a two out of every three-week regimen, to explore if more frequent administration can provide additional activity in patients with metastatic melanoma.

Ronit Simantov, chief medical officer of CuraGen, said: “We would like to thank our investigators for their enthusiasm, which we believe is highlighted by their ability to fully enroll this Phase II trial in just six months, and we look forward to reporting the final data from this Phase II trial during the first half of 2009.”