CancerVax Corporation and Serono will discontinue the Phase 3 clinical trial of Canvaxin in patients with Stage III melanoma based upon the recommendation of the independent Data and Safety Monitoring Board (DSMB), which recently completed its planned, third, interim analysis of the data from this study.
The DSMB found that the data are unlikely to provide significant evidence of an overall survival benefit for patients with Stage III melanoma who were treated with Canvaxin versus those who received placebo.
David F. Hale, president and CEO of CancerVax Corporation said, "We will discontinue all further development and manufacturing operations for Canvaxin, but we currently plan to continue to further the development of the other product candidates in our product pipeline, which we believe hold promise for the treatment of patients with cancer."
"The Phase 2 results were promising, and we were thus hopeful that this highly innovative product would be successful in a Phase 3 clinical trial in patients with Stage III melanoma," Franck Latrille, Senior Executive Vice President, Corporate Global Product Development of Serono said adding, "We continue to have a strong pipeline with five Phase 3 programs and significant newsflow expected in the next year. Serono remains committed to oncology with Humax-CD4, adecatumumab and TACI-Ig, with study results from all three programs expected in 2006."
According to a company release, the recommendations to close both of these clinical trials were not made because of any potential safety concerns.