Theriva Biologics receives FDA guidance for Phase 3 study of VCN-01 in metastatic pancreatic cancer

Theriva Biologics, Inc.

FDA advised stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel; VIRAGE Phase 2b should not be expanded into Phase 3.
FDA generally agreed with Theriva's proposed Phase 3 design; no additional chemotherapy needed for PDAC.
VIRAGE Phase 2b enrollment completed; final patient follow-up is underway.
Additional FDA meeting planned after VIRAGE completion to discuss Phase 3 protocol details.

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