CURAGEN ANNOUNCES RESULTS OF VELAFERMIN STUDY
CuraGen has announced additional results from its Phase II randomized, placebo-controlled clinical trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM) in patients receiving high-dose chemotherapy, with or without total body irradiation (TBI), prior to autologous bone marrow transplantation (BMT).
The safety and efficacy trial was designed to evaluate a dose dependent reduction in the incidence of OM across three doses of velafermin compared to placebo. Results showed that 0.03 mg/kg velafermin, the lowest dose evaluated, significantly reduced the incidence and duration of severe OM compared to placebo. The primary analysis, prospectively defined as a dose dependent trend in the reduction of severe OM, did not reach statistical significance.
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