CURAGEN ANNOUNCES RESULTS OF VELAFERMIN TRIAL
CuraGen has reported preliminary top-line results from its Phase II randomized,
placebo-controlled clinical trial evaluating a single-dose of velafermin for
the prevention of oral mucositis in patients receiving high-dose chemotherapy,
with or without total-body irradiation, prior to autologous bone marrow transplantation.
Analysis of this dose-ranging study showed a reduction in oral mucositis incidence
in one of the three velafermin dose arms compared to placebo, although the primary
endpoint, as evaluated by a predefined dose trend analysis did not reach statistical
significance.
The trial was a randomized, double-blind, placebo-controlled trial evaluating
a single administration of either placebo or one of three doses of velafermin
given to patients one day after bone marrow transplantation. The primary analysis
of the study examined a linear trend in dose across the 0.03 mg/kg, 0.1 mg/kg,
and 0.2 mg/kg velafermin arms compared to placebo. An analysis of each individual
dose group versus placebo was also conducted, as well as the evaluation of secondary
endpoints including duration of Grade 3 and 4 oral mucositis, use of narcotic
pain medications, time to neutrophil engraftment, and the incidence and duration
of diarrhea.
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