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Genentech Stops Enrollment in Clinical Trial

A safety review board has halted enrollment in a clinical trial involving Avastin, a colon cancer drug manufactured by one of the world’s largest and oldest biotechnology companies in its San Diego plant.

Stock in South San Francisco-based Genentech closed down $1.92, or 2.3 percent, at $81.60 the day of the news, Feb. 13.

Genentech announced it would stop enrolling people in the international Phase III trial, which is the last stage before consideration for approval by the Food and Drug Administration, because of concerns about several sudden deaths.

The trial’s own safety monitoring board recommended suspending enrollment while it reviews 60 days worth of data to ensure safety.

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Avastin is already approved by the FDA for colorectal cancer that has spread to other parts of the body, but the Avant trial, as the company calls it, is evaluating if Avastin might lower risk of recurrence in colorectal cancer when combined with chemotherapy following surgery.

The trial will continue for now with about two-thirds the number of people the company originally intended, according to Genentech. The target number was 3,450.

The company, which began recruiting for the Avant trial in 2004, said in some months it had more than 200 people wanting to enroll in the study.

The trial’s death rate has ranged among three groups between 0.4 percent and 1 percent, with 14 deaths in all. The company said at least two were cardiac-related. Some of the 14 deaths occurred among young participants, concerning researchers.

Genentech spokeswoman Colleen Wilson said San Diego plant manager David Broad was unavailable for comment, but confirmed that the halting of enrollment for the Avant study involving Avastin would not affect the company’s Oceanside operation.

“It will not affect our current usage nor plans to file later this year to get Avastin approved for metastatic breast cancer and advanced non-small-cell lung cancer,” Wilson said.

, Katie Weeks


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