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Article: Therion Starting Panvac-VF Phase III Under SPA Program.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Senior Staff Writer
Therion Biologics Corp. is moving its lead vaccine candidate into Phase III work.
The Cambridge, Mass.-based company plans to begin this summer a trial evaluating Panvac-VF in metastatic pancreatic cancer patients who have failed treatment with gemcitabine. The FDA signed off on the study, which will be conducted under the agency's special protocol assessment (SPA) program. It ensures that if the trial successfully meets its primary endpoint - in this case, overall survival compared with best supportive care or palliative chemotherapy - the data will provide the basis for an efficacy claim in an eventual new drug application.