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news.US biopharmaceutical company CuraGen has announced that its Phase II trial evaluating a single dose of velafermin for the prevention of severe oral mucositis failed to meet its primary endpoint.
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Based on these results, Curagen is discontinuing the development of velafermin, and will continue to focus its resources on belinostat, a Phase II histone deacetylase 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.
The trial was 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.
The primary endpoint was a decrease in the incidence of severe oral mucositis in patients receiving 30mcg/kg velafermin compared to placebo. Secondary endpoints evaluated included duration of oral mucositis, patient self-reported pain score, use of pain medications, the incidence and duration of febrile neutropenia, and use of enteral or parenteral nutrition.
Timothy Shannon, president and CEO of CuraGen, said: “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.”