CuraGen Announces Top-Line Phase II Results on ...( - Conference call to be hosted ...),Health

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BRANFORD, Conn., Oct. 11 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today that its Phase II dose-confirmatory clinical trial (CLN-12) evaluating a single dose of velafermin for the prevention of severe oral mucositis demonstrated that velafermin was safe and well-tolerated but did not meet its primary endpoint. Based on these results, the Company is discontinuing the development of velafermin, and will continue to focus its resources on belinostat, a Phase II histone deacetylase (HDAC) inhibitor for the treatment of solid tumors and hematologic malignancies, and CR011-vcMMAE, a Phase I/II antibody-drug conjugate for the treatment of metastatic melanoma.

"While we are disappointed that the primary endpoint was not met in this study, on behalf of everyone at CuraGen, I would like to thank all of the patients and investigators who took part in the velafermin development program," commented Timothy Shannon, President and Chief Executive Officer of CuraGen. "We continue to aggressively focus on our goal of advancing the belinostat and CR011-vcMMAE programs toward initiation of Phase III development in 2008, and we look forward to presenting updated clinical trial results on these programs in October at the AACR-NCI-EORTC conference, and in December at the ASH Annual Meeting."

CLN-12 was a randomized, double-blind, placebo-controlled study designed to assess a reduction in the incidence of severe Grade 3 or 4 oral mucositis in patients receiving high-dose chemotherapy followed by autologous bone marrow transplantation (BMT). The trial enrolled 390
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