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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation
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From: scaram(o)uche4/6/2005 3:04:37 AM
   of 631
 
Serono Announces Discontinuation of Onercept in Moderate-to-Severe Psoriasis and Canvaxin(TM) in Stage IV Melanoma
Wednesday April 6, 1:00 am ET

GENEVA, April 5 /PRNewswire-FirstCall/ -- Serono (NYSE: SRA; virt-x: SEO) announced today the discontinuation of two phase 3 clinical trial programs; onercept (recombinant tumor necrosis factor binding protein) in moderate-to-severe psoriasis and Canvaxin(TM) in Stage IV melanoma, licensed from CancerVax. The decision to discontinue these clinical trials is based on the recommendations of two separate independent Data and Safety Monitoring Boards (DSMBs).


Onercept in moderate-to-severe psoriasis

In 2004, Serono initiated three phase 3 clinical trials in moderate-to-severe psoriasis. Investigators have recently reported two patients diagnosed with sepsis, one of whom subsequently died. Sepsis is a recognized potential risk for patients treated with anti-tumor necrosis factor (TNF) therapies. Serono convened a meeting of the independent DSMB to evaluate the available blinded efficacy data at 12 weeks for the two placebo-controlled pivotal trials and data from the first 12 weeks of the open-label trial. It was determined based on these aggregate data that the efficacy response observed for onercept was less than that observed in the earlier phase 2 trial, and with other available treatments. As a consequence of its unfavorable risk-benefit profile, the DSMB recommended to discontinue the clinical development of onercept in moderate-to-severe psoriasis.

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