Celgene temporarily suspends Revlimid trial

Reuters - Celgene Corp. on Wednesday said it expects a suspended trial of its cancer drug Revlimid to resume within weeks, after the trial design is changed to ensure all patients receive aspirin to reduce the chance of developing blood clots.

Celgene confirmed a published report that the Phase III trial, involving patients recently diagnosed with multiple myeloma, had been suspended after some developed blood clots during treatment with Revlimid in combination with a steroid called dexamethasone.

Celgene, whose shares fell nearly 4 percent, said patients with the blood cancer typically develop blood clots after being treated with standard drugs, as well as with the company's experimental Revlimid.

But company spokesman Brian Gill said low incidence of such clots was seen in similar patients taking Revlimid in a smaller Phase II trial conducted by the same Mayo Clinic doctor who has supervised the recently suspended larger trial. In the earlier trial, he said patients received aspirin, and will do so in the revamped Phase III trial to avert risk of blood clots.

"The Mayo Clinic has told us the trial design will be changed to include aspirin for everyone and the information they have given us suggests the trial will be resumed in the next few weeks," Gill said. "Without question, the trial will resume."

Moreover, Gill said Celgene is continuing with plans to seek U.S. approval later this year for use of Revlimid to treat patients with later stages of multiple myeloma.

That application will be based on two large late-stage trials in which Revlimid plus chemotherapy significantly delayed progression of multiple myeloma in such late-stage patients, compared with chemotherapy alone.

Merrill Lynch analyst Eric Ende said the suspended multiple myeloma trial is unlikely to affect either the FDA's upcoming decision on use of the drug for myelodysplastic syndromes, or the company's planned application to use it to treat multiple myeloma.