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www.fdanews.com/articles/81606-serono-cancervax-stop-development-of-canvaxin

SERONO, CANCERVAX STOP DEVELOPMENT OF CANVAXIN

October 12, 2005

Serono and its development partner CancerVax have halted clinical trials and development of an experimental melanoma drug after an independent review found the drug was likely no more effective than a placebo.

The firms decided to halt development of Canvaxin after an independent data and safety monitoring board completed a third, interim analysis of data from clinical trials of the drug. The review found the drug was unlikely to provide significant evidence of an improved benefit for patients with Stage III melanoma over those that received a placebo, the companies said. CancerVax had previously ended clinical trials of the drug's effectiveness for Stage IV melanoma.

The company added that there were no significant safety issues identified with either the Phase III clinical trial of the cancer drug for patients with Stage III melanoma or an earlier clinical trial of Canvaxin for Stage IV melanoma.

As a result of the decision, CancerVax has laid off more than 100 of its employees. In a recent release, the company announced it would reduce its workforce from 183 employees to approximately 80 employees.

Serono, the largest biotechnology company in Europe, said it would continue to introduce cancer-fighting drugs. "We continue to have a strong pipeline with five Phase III programs and significant newsflow expected in the next year," said Franck Latrille, Serono's senior executive vice president of corporate global product development. Serono expects to release study results from three oncology programs — Humax-CD4, adecatumumab and TACI-Ig — in 2006, Latrille said.