Serono was delivered a blow this morning after revealing that it had been forced to discontinue two Phase III clinical trial programmes on the back of recommendations from two separate, independent data and safety monitoring boards.
The Swiss biotechnology company said that investigators had recently reported that two patients in a clinical trial of onercept in the treatment of moderate-to-severe psoriasis, were diagnoses with sepsis – one of whom subsequently died. Although sepsis is a recognised potential risk for patients being treated with anti-tumour necrosis factor therapies, such as onercept, Serono says that the overall risk/benefit profile did not warrant continuation of the study.
The firm says that a data and safety monitoring board also recommended discontinuation of a study of Canvaxin for melanoma, saying that the data were unlikely to provide significant evidence of a survival benefit for Canvaxin-treated patients with Stage IV melanoma versus those receiving placebo. It did, however, back the continuation of a study of the drug in Stage III melanoma.
Serono’s share price took a knocking on many of the European stock markets this morning on the news, which has delivered a significant blow to the firm’s product pipeline. Industry observers are keen for the company to reduce its reliance on its flagship multiple sclerosis offering, Rebif (interferon beta-1a). Serono only recently acquired the rights to Canvaxin from CancerVax as part of a bid to beef up its oncology portfolio [[17/12/04g]].