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Biotech / Medical : biotech firesales -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (709)	10/19/2004 4:15:57 PM
From: tuck	Respond to of 3661

AGEN of 15%+ on news of Oncophage likely needing another trial before approval: >>LOS ANGELES, Oct 19 (Reuters) - Shares of Antigenics Inc. (AGEN.O: Quote, Profile, Research) fell 14 percent on Tuesday after the company said it may have to conduct another trial before U.S. regulators will consider approving its experimental cancer vaccine Oncophage. The stock was down 85 cents at $5.01 in late trading on Nasdaq. "It is becoming increasingly obvious that the timeline for the vaccine will be longer than originally expected," said Mark Monane, an analyst at Needham & Co. Antigenics expects to report in the first half of next year results from a Phase 3 trial of Oncophage in kidney cancer patients that would be the basis for a new drug application to the U.S. Food and Drug Administration. The FDA, however, has said results from that trial will not be adequate because the product used in the trial did not meet testing standards. Antigenics plans to ask the agency to reconsider once the trial results are available, assuming they are positive, Antigenics Chief Executive Garo Armen told Reuters. "It is my conviction that the agency will listen to our case," he said. "There are no alternative products for these patients." The CEO said Oncophage is "a well-characterized product and retrospective testing of that characterization for quality purposes should be considered." Meanwhile, Antigenics plans to launch another kidney cancer trial before the end of this year, the results of which would be the basis for an FDA application if the agency continues to refuse results from the first trial. Oncophage is an injection containing purified proteins from a patient's own tumor and is designed to alert the body's immune system to destroy the cancer. Antigenics also on Tuesday reported a third quarter loss of $18.7 million, or 41 cents a share. The company had $106 million in cash and short-term investments at the end of the quarter.<< Cheers, Tuck