CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial i...( - RECIST-defined objective response...),Health

- RECIST-defined objective response supports expansion of Simon 2-Stage

designed trial -

BRANFORD, Conn., June 11 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today that its Phase II Trial evaluating CR011-vcMMAE for the treatment of patients with unresectable Stage III or Stage IV melanoma has met the efficacy criteria for advancement to the second stage of enrollment. 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.

"We are very encouraged by the emerging clinical efficacy of CR011-vcMMAE. We believe that this objective response confirms the initial activity observed in the Phase I trial, the results of which were reported earlier this month at ASCO," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen Corporation. "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 this year."

Dr. Ronit Simantov, Vice President and Chief Medical Officer commented, "There remains a substantial unmet need for patients with advanced melanoma. As we continue to evaluate CR011-vcMMAE 1.88 mg/kg given once every three weeks in this ongoing Phase II trial, we are also looking to further optimize the activity of CR011-vcMMAE by actively exploring alternative dosing schedules including more frequent intravenous administration of this novel agent."

This ongoing open-label, multi-center Phase II study e
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