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Serono, CancerVax Halt Clinical Trial


Posted on 2005-04-06 06:10:00



Swiss biotech company Serono SA and CancerVax Corp. of the U.S. have discontinued a late-stage clinical trial of a treatment for advanced skin cancer. Serono also said it has discontinued a separate late-stage trial of a treatment for psoriasis. Both trails were halted on the advice of two separate data and safety monitoring boards.

The first trial involved the use of Canvaxin for the treatment of Stage IV melanoma, or skin cancer that has spread past the site of origin to distant areas or lymph nodes. Data showed that the treatment was unlikely to provide significant evidence of a survival benefit, Serono said.

Canvaxin uses inactivated cancer cells or proteins to stimulate a cancer patient's immune system to recognize and attack the living cancer cells. Serono, which carries a product portfolio of neurology, growth and metabolism, and reproductive health treatments, was using the collaboration to break into the cancer treatment market. Serono's current best selling drug is the multiple sclerosis treatment Rebif, which brought in $1.09 billion, or half the company's total sales, in 2004.

Serono said that it plans to continue another ongoing clinical trial for Canvaxin using the treatment in patients with Stage III melanoma, or skin cancer that has spread to regional lymph nodes. The company expects a further analysis of data from this trial in the third quarter with a final analysis in mid-2006. The other Phase III trial discontinued by Serono was studying the use of tumor necrosis factor binding protein Onercept for the treatment of moderate-to-severe psoriasis. Investigators in this trial reported that two patients were diagnosed with a life-threatening blood infection, one of which later died. The company discontinued the trial based on an unfavorable risk-benefit profile.