FDA Places Partial Hold on Trials of Oncophage for Colorectal Cancer

Antigenics Inc. said the U.S. Food and Drug Administration has placed on partial hold late-stage clinical trials of the personalized therapeutic vaccine Oncophage pending receipt of further information.

Only two weeks ago, the company reported that more than half of the patients with advanced colorectal cancer treated with Oncophage® appeared to benefit from it (see earlier Colorectal Cancer Week story).

Antigenics said safety of the Oncophage vaccine was not an issue in discussions with the FDA, and patients already enrolled in phase III trials could continue with their course of treatment.

"Our main priority is to work with the FDA to resolve these product characterization issues as quickly as possible," said Garo H. Armen, PhD, chairman and chief executive officer of Antigenics. "We expect to provide the FDA with the required information within the next six to eight weeks."

Antigenics reported in mid-August that all 15 of the colorectal cancer patients whose immune systems responded to Oncophage were alive 2 years after the treatment, compared to only half of the patients who did not respond to the vaccine.

Other sources: Antigenics