Of the first six evaluable patients in this 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 will now expand to enroll a total of 32 patients.
This ongoing open-label, multi-center Phase II study evaluating CR011- vcMMAE in patients with advanced melanoma utilizes a Simon 2-Stage design with a primary endpoint of objective response rate.
Patients enrolled in the study may have received no more than one prior cytotoxic regimen, but may have received an unlimited number of prior cytokine, immune or vaccine therapies. Enrollment in the study is expected to be completed by the end of 2008.
Timothy Shannon, president and CEO of CuraGen, said: “This trial is enrolling well, and we expect the data to quickly mature allowing us to provide further updates from the study later in the second half of 2008.”