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CuraGen Begins Velafirmin Trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

CuraGen Corp. has initiated patient dosing in a Phase II trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM). This is the second Phase II study of velafermin and is designed to assess the safety and efficacy of velafermin for the prevention of OM in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation (BMT).

This multi-center, randomized, double-blind, placebo-controlled, Phase II trial will enroll approximately 400 patients. The primary endpoint is the incidence of severe OM following intravenous administration of velafermin compared to placebo. Secondary endpoints include duration of OM, patient self-reported pain score, use of pain medications, the incidence and duration of febrile neutropenia, and use of enteral or parenteral nutrition. Patients receiving one of three common myeloablative regimens prior to autologous BMT for the treatment of multiple myeloma, Hodgkin’s lymphoma, or non-Hodgkin’s lymphoma will be eligible for enrollment at approximately 30 to 40 sites across the U.S.

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