The company said there would be a delay in the clinical program for XL999 of between two weeks and three months until further data have been collected and analyzed.
Exelixis suspended enrollment after a preliminary review of patient data relating to cardiovascular adverse events. In October 4 of the 14 patients’ enrolled experienced serious adverse cardiovascular events which raised a concern with the company’s internal safety monitoring committee. The company therefore decided to suspend enrollment of new patients pending further review of the data.
“Our primary responsibility is the safety of the patients in the trial, and so we are suspending the enrollment of new patients until we have had a chance to analyze the data. Since all but one of the events occurred on first administration of XL999, we are continuing to treat those patients presently enrolled in the trial,” said George Scangos, CEO of Exelixis.