Genentech Closes Drug Trial

Biotechnology company Genentech Inc. said Monday that it temporarily halted recruiting volunteers for a large human test of the blockbuster cancer drug Avastin after more patients died than expected.

The deaths occurred among colon-cancer patients taking Avastin with a chemotherapy regimen called XELOX.

Since the test was started in December 2004, seven patients taking that combination died, four of them suddenly, said the company’s majority stockholder, Switzerland-based Roche Holding.

“An occurrence of sudden deaths, especially in three younger patients, was noted,” Roche said, adding that the temporary suspension would allow “a full safety assessment.”

Those seven deaths compare with four deaths in another arm of the study that combined Avastin with a different chemotherapy called FOLFOX.

About 2,000 patients who are already receiving one of three combinations of Avastin and the chemotherapy regimens will continue to receive their drugs.

The rest of the volunteers -- researchers plan to add about 1,450 more -- won’t be enrolled for at least 60 days while the companies try to find what caused the deaths.

The test is designed to see if Avastin can safely be used to prevent colon cancer from recurring in patients in remission.

The Food and Drug Administration approved Avastin for patients with advanced colon cancer in 2004 and the drug accounted for $1.1 billion in sales for Genentech last year.

Basel, Switzerland-based Roche owns sales rights in Europe, where it was approved last year.

Wall Street analysts said they were optimistic the deaths wouldn’t immediately affect the companies’ finances because it was too early to know if Avastin, the combination of Avastin and XELOX or something unrelated to the drugs caused the deaths.

“There is no information here to condemn Avastin,” said Jason Kantor, an analyst with RBC Capital Markets in San Francisco.

Kepler Equities analyst Denise Anderson wrote in a note to investors that patients in the trial would stay on Avastin “and that only one combination is at issue indicates that the problem may not ultimately be that serious.”

Avastin chokes the blood supply that feeds tumors and is the first drug of its kind to be approved by the FDA.

Shares of San Francisco-based Genentech fell $1.92, or 2.3%, to $81.60.