CancerVax Corporation announced today plans to discontinue the Phase 3 clinical trial of Canvaxin(TM) in patients with Stage IV melanoma based upon the recommendation of the independent Data and Safety Monitoring Board (DSMB), which recently completed its planned, second, interim analysis of the data from this study.
The DSMB found that the data are unlikely to provide significant evidence of a survival benefit for Canvaxin-treated patients with Stage IV melanoma versus those receiving placebo.
Based on a limited review of data from the Phase 3 clinical trial of Canvaxin(TM) in Stage III melanoma, the DSMB recommended that this clinical trial continue as planned.
CancerVax and Serono, CancerVax's worldwide development partner for Canvaxin(TM), intend to continue the Phase 3 clinical trial in Stage III melanoma, and expect that the DSMB will review the third interim analysis of data from this clinical trial in the third quarter of 2005.
It is anticipated that the final analysis of data from this clinical trial will take place after the required number of clinical events have occurred, which is currently estimated to occur in mid-2006.
There were no safety issues identified with either of the Phase 3 clinical trials of Canvaxin, and the recommendation to close the Stage IV study was not made because of any potential safety concern.
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