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Partial clinical hold on phase III trials of cancer vaccine Oncophage.
2003 OCT 1 - (NewsRx.com & NewsRx.net) -- Antigenics, Inc., (AGEN) announced that it had completed a meeting with the U.S. Food and Drug Administration (FDA) on product characterization issues.
Following a discussion of the company's personalized cancer vaccine Oncophage (HSPPC-96), the FDA has requested additional product characterization information from Antigenics. Pending receipt and acceptance of such information, the agency is placing on partial clinical hold the phase III trials of Oncophage under its investigational new drug (IND) application, which includes trials in kidney cancer and metastatic melanoma.
The FDA said ...
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Source: HighBeam Research, Partial clinical hold on phase III trials of cancer vaccine Oncophage.