Theriva Biologics Announces It Receives FDA's General Agreement For Phase 3 Clinical Study Of VCN-01 To Treat Metastatic Pancreatic Adenocarcinoma

Theriva Biologics (NYSE American: TOVX) has received general agreement from the FDA for the design of a Phase 3 clinical study of its lead candidate VCN-01, aimed at treating metastatic pancreatic adenocarcinoma in combination with standard chemotherapy. This Phase 3 trial design closely follows the successful VIRAGE Phase 2 trial, which demonstrated improved overall survival and progression-free survival for patients receiving VCN-01. The upcoming trial will incorporate repeat dosing and an adaptive design to enhance outcomes and timelines.