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Recruitment in Roche Avastin trial suspended

Swiss firm to carry out a 60-day safety evaluation after sudden deaths of four patients

Roche has temporarily suspended patient enrolment into a clinical trial of colon cancer drug Avastin, after the sudden deaths of four volunteers.

The phase III trial, titled AVANT was being run to assess the use of Avastin in combination with traditional chemotherapy drugs in patients who have already undergone at least four surgeries.

On February 13, Roche agreed to the recommendations of a safety board and temporarily suspended recruitment in the study while Avastin undergoes a 60-day safety evaluation. The Swiss firm said patients already enrolled would continue treatment, as the decision was just a precautionary measure.

Avastin project leader, Peter Wenner, said that in the adjuvant (post-surgery) setting, the efficacy of the drug had to be significant to outweigh any side effects, compared to the metastatic setting where patients had no choice and could only hope for prolongment of and improved quality of life.

The temporary suspension was called for by the trial's safety monitoring board following four sudden deaths in one of the three study arms, which involved patients taking Avastin plus the chemotherapy treatment Xelox, comprising Roche's Xeloda and oxaliplatin. Avastin is used in combination with Xeloda in its approved indication to treat metastatic colorectal cancer, but there have been no reported safety issues.

William Burns, chief executive of Roche's pharmaceuticals division, said that after the two-month review, the company would decide how to restart recruitment.

ìIt could lead to an even more dramatic recruitment if everything is going fine, or it could lead to a refinement in the study or it could lead to dropping one of the study arms,î he told Reuters. ìThere are a number of outcomes, but it really is premature to speculate.î

Although shares in Roche dipped on the news, analysts said they were not unduly concerned.

ìThis won't have an impact on the drug's peak sales estimates,î said Hernani De Faria at Zuercher Kantonalbank, who kept Avastin peak sales estimates at SwFr7.9bn by 2010. ìThe safety concerns involve only one part of the 14 ongoing studies, so the impact is limited.î

Avastin, developed by Roche and its US biotech partner, Genentech, was approved in Europe for colon cancer in January 2005 and is the first approved medicine that works by choking off the blood supply to tumours.

30th September 2008

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