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FDA Says Oncophage Clinical Trials Can Resume

NEW YORK--(BUSINESS WIRE)--Nov. 24, 2003--Antigenics Inc. (NASDAQ: AGEN) announced today that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the two Phase III clinical trials of the company's personalized cancer vaccine Oncophage(R) (HSPPC-96). The agency's decision to lift the hold comes 13 weeks after its request for product characterization information in September 2003. Antigenics will immediately resume patient enrollment in its Phase III trials of Oncophage.

"Our team worked hard to provide the information within our targeted timelines," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "We are grateful for the FDA's rapid and thorough review of our submission."

The FDA had placed two Antigenics studies on partial clinical hold to review product characterization data. All other Oncophage trials, including Phase I and II studies, were unaffected by the hold.

Source: Antigenics Inc.

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