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Deaths Cause Suspension of Enrollment in Avastin Clinical Trial

Feb 14, 2006 | Newsinferno News Staff

As reported by Reuters, “a number of sudden deaths” has prompted Roche Holding AG and Genentech to “temporarily suspend recruitment of patients into a clinical trial assessing the use of colon cancer drug Avastin after surgery.”

The trial is designed to see how patients respond when given either conventional chemotherapy drugs or an Avastin-based combination. The Phase III trial that goes by the name AVANT, is a final-stage test meaning the drug was nearing the point when a New Drug Application would have been expected.

The company said on Monday that its “broad oncology program,” which it is working on with majority-owned Genentech, remained “on track” despite the suspension.

According to the Reuters report, William Burns, Roche's head of pharmaceuticals, said the decision would not cause a financial impact. "No, none at all because the hypothesis for the trial is a hypothesis and the financial community does not know whether it is going to play out or not play out," he told Reuters in a telephone interview.

But some analysts believe the suspension will be unsettling for investors, given Roche's high valuation, which is largely based “on the success of its cancer business.” 

"While numbers are unlikely to change it raises the risk that Avastin will not be approved in further indications or that off-label use will be more limited," they noted. is following this breaking story and will have a follow-up as soon as details become available.

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