To date, more than 200 patients have been treated with velafermin in this trial, and the last patient is expected to be enrolled by the end of September.
“CuraGen’s oncology pipeline continues to mature, as highlighted by the anticipated completion of our velafermin phase II clinical trial. Data from this study will enable us to finalize the most efficient and appropriate development strategy for this promising protein therapeutic, and if data are supportive, lead to the initiation of a phase III program in 2006,” Dr Timothy Shannon, executive vice president of R&D, and chief medical officer at CuraGen.
The trial is being conducted at 20 sites across the US and has treated more than 200 patients. Patients are randomized to receive a single administration of either placebo or one of the three dosages of velafermin following bone marrow transplantation. The primary endpoint for the study is the development of clinically significant grade 3 or 4 oral mucositis. The study also includes a 90-day post-treatment safety evaluation. The company expects to present the top-line results at a medical conference during the first quarter of 2006.