CuraGen starts second phase 2 velafermin trial

By Elaine Rigoli

Tampa, Fla., May 30 - CuraGen Corp. said Tuesday that it has started patient dosing in a second phase 2 clinical trial evaluating a single dose of velafermin for the prevention of oral mucositis, or painful mouth ulcerations.

This clinical trial is designed to assess the safety and efficacy of velafermin for the prevention of oral mucositis in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation, the company said in a news release.

This multi-center, randomized, double-blind, placebo-controlled trial will enroll about 400 patients. The primary endpoint is the incidence of severe oral mucositis following intravenous administration of 30 mcg/kg velafermin compared to a placebo.

Secondary endpoints being evaluated include 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.

CuraGen is a biopharmaceutical company based in Branford, Conn.

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