BASEL, Switzerland (AP) _ Pharmaceutical maker Roche Holding AG said Monday it has stopped recruiting patients to test its cancer drug Avastin in late stage clinical trials after the deaths of four patients.
The Basel-based company said it has stopped adding patients to its Phase III trial, known as AVANT, which tests Avastin in combination with other drugs to treat post-surgical colon cancer.
There will be a further review of safety data after the deaths of four patients in one part of the trial, which tests a combination of Roche's chemotherapy regimen Xelox and Avastin, the company said.
The company decided to stop recruitment because of ``a safety concern observed in one of the three study arms'' as well as the fast recruitment for the AVANT trial which, at more than 200 patients a month, could prevent adequate and timely intervention.
``An occurrence of sudden deaths (4), especially in three younger patients, was noted,'' Roche said in a statement, adding that the temporary suspension would allow ``a full safety assessment.''
William M. Burns, chief executive of Roche's pharmaceutical division, said the 2,000 patients already taking part in the trial will continue their treatment as planned.
Kepler Equities analyst Denise Anderson wrote in a note to investors that the fact that patients in the trial will stay on Avastin ``and that only one combination is at issue indicates that the problem may not ultimately be that serious.''
Roche shares were down 1.25 percent at 189.50 Swiss francs (US$145.06; euro121.83) in Zurich trading.
Avastin, which works by choking off a tumor's blood supply, is Roche's fifth best-selling drug, with sales of US$1.7 billion (euro1.4 billion) in 2005. It was approved as a first-line treatment of colorectal cancer in the U.S. in early 2004. It received regulatory approval in Europe in the beginning of 2005.
Biotechnology firm Genentech Inc. also said Monday it stopped enrolling patients in a study of Avastin, citing safety concerns. The California-based company, in which Roche holds a majority interest, called for the temporary halt to recruitment because of a higher rate of deaths compared to another chemotherapy treatment.