and its marketing partner
are resuming enrollment of a study on colon cancer drug Avastin after halting the accrual of new patients to investigate a number of deaths.
The decision follows a 60-day review by an independent data safety monitoring board to assess the occurrence of the heart-related and unexplained deaths.
Excluding deaths due to recurrent colon cancer, there were six deaths in patients receiving a chemotherapy regimen called Folfox-4, four deaths in patients receiving Folfox-4 plus Avastin and eight deaths in patients taking the Xelox chemotherapy regimen plus Avastin.
The board established that the trial's safety profile as well as the number of deaths were consistent with those seen in other early-stage colon cancer studies and recommended that the companies resume the trial, the companies said.
Before enrollment was halted, two-thirds of the target number of 3,450 patients had already been enrolled and continued treatment according to the trial's protocol.
Genentech's shares were up 69 cents, or 0.9%, to $79.13 Tuesday morning.