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news.Serono has stopped phase III clinical trial programs for both onercept in moderate-to-severe psoriasis and CancerVax Corporation co-developed Canvaxin in melanoma. The news has caused a slight dip in Serono's shares, but has almost halved CancerVax' stock.
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The decision to discontinue the clinical trials is based on the recommendations of two separate independent data and safety monitoring boards (DSMBs).
The onercept (recombinant tumor necrosis factor binding protein) psoriasis trials have been discontinued after the DSMB found the treatment candidate’s benefits failed to outweigh its risks. Investigators recently reported two patients diagnosed with sepsis, one of whom subsequently died, and aggregate data showed that onercept’s efficacy response was less than that observed in an earlier phase II trial, and with other available treatments.
The DSMB for Canvaxin recommended its discontinuation as the data are unlikely to provide significant evidence of a survival benefit for patients with Stage IV melanoma compared to placebo. No safety issues were reported.
However, the DSMB did say that the currently on-going phase III clinical trial of Canvaxin in Stage III melanoma should continue. The final analysis of data from this clinical trial will take place after the required number of clinical events will have occurred, which is currently estimated to be around mid-2006.