This article was originally published in Pharmaceutical Approvals Monthly
Second Phase II study of the oral mucositis (OM) prevention treatment velafermin for patients receiving high-dose chemotherapy prior to an autologous bone marrow transplant for hematologic cancer will begin in the second quarter despite the failure of an initial Phase II study to achieve its primary endpoint - a dose dependent trend in the reduction of severe OM, CuraGen says. The initial trial showed that the lowest dose of the novel fibroblast growth factor evaluated (0.03 mg/kg) produced a significant reduction in the incidence and duration of severe WHO Grade 3 or 4 OM versus placebo. "Despite the lower than expected incidence of OM in the placebo group, and its impact on the statistical assumptions that went into this trial, we achieved our goal of identifying an active single dose of velafermin that we now hope to confirm in a second, well-controlled Phase II study," stated Exec-VP R&D Timothy Shannon. Plans for the new study follow analysis of results first reported in December (1Pharmaceutical Approvals Monthly January 2006, In Brief)...
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