- Activity Demonstrated in Advanced Breast Cancer and Melanoma -

- Conference call to be hosted Wednesday, June 3, 2009 at 11:00am ET to discuss results -

BRANFORD, Conn., June 2 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN) reported three data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB, in patients with advanced breast cancer and melanoma at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida.

The Phase I/II study of CR011-vcMMAE administered intravenously once every three weeks in patients with advanced breast cancer began with a bridging phase to confirm the maximum tolerated dose and has expanded into a Phase II open-label, multi-center study. The study is designed to assess efficacy with an endpoint of progression-free rate at 12 weeks. The principal investigator is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research Program and Associate Professor of Clinical Medicine, NewYork-Presbyterian Hospital/Weill Cornell.

Preliminary data were presented on 18 evaluable patients treated at doses of 1.0 - 1.88mg/kg from the Phase I portion and the initial portion of the Phase II study. Selection for enrollment was not based on expression of GPNMB in patients' tumors. The median number of prior chemotherapy regimens for metastatic disease was 4 (range 2-11). Triple negative disease (ER/PR/Her-2 negative) was present in 44% of patients. Partial responses were seen in 3 patients (1 confirmed), including a patient with triple negative disease. Fifty percent (50%) of patients showed tumor shrinkage. Toxicities were similar to those observed in previous studies with CR011-vcMMAE; the most common adverse events were rash, alopecia, and fatigue. Twelve patients have now been enrolled in the Phase II portion of the study at a dose of 1.88mg/kg given once every three weeks, with total Phase II enrollment planned for up to 25 patients.

'We are very encouraged by the early evidence of activity demonstrated in this trial and look forward to presenting additional data on the Phase II study in the second half of the year,' commented Dr. Ronit Simantov, Chief Medical Officer of CuraGen. 'The emerging role of GPNMB, which is present in 25-40% of breast cancer patients, combined with our clinical activity, suggests that GPNMB may be an important new target in breast cancer.'

Also at ASCO, data from a Phase II trial of CR011-vcMMAE in patients with advanced melanoma were presented at a poster discussion session. Thirty-six patients were enrolled into this Phase II open-label, multi-center trial that evaluated the efficacy and safety of CR011-vcMMAE 1.88 mg/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.

The study successfully met its primary activity endpoint, with 5 objective responses (1 unconfirmed) observed in 34 evaluable patients, and median duration of response of 5.3 months. The median overall progression-free survival (PFS) was 4.4 months. Tumor shrinkage was observed in 58% of patients, and 20 patients had best response of stable disease. Dermatologic adverse events consisting of rash, alopecia, and pruritus were the most common toxicities in this study. Other adverse events included fatigue, diarrhea, anorexia and nausea. Grade 3 or 4 neutropenia was observed in 5 patients. The absence of rash in the first cycle of treatment predicted a worse PFS.