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# Theriva’s Pancreatic Cancer Drug Hits Endpoints
- URL: https://www.fdaweb.com/therivas-pancreatic-cancer-drug-hits-endpoints/
- Published: 2025-05-07T12:00:00.000Z
- Updated: 2026-09-14T15:11:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159132

Theriva Biologics says its VCN-01 (zabilugene almadenorepvec) hit its endpoints in the VIRAGE Phase 2b trial using VCN-01 and standard of care (gemcitabine/nab-paclitaxel) as first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma. A company [statement](https://therivabio.com/press%5Freleases/theriva-biologics-announces-primary-endpoints-for-efficacy-and-safety-achieved-in-virage-phase-2b-clinical-trial-of-vcn-01-with-gemcitabine-nab-paclitaxel-in-newly-diagnosed-metastatic-pancre/?ref=fdaweb.com) says 48 patients treated with at least one dose of gemcitabine/nab-paclitaxel had a median overall survival of 8.6 months, while 48 patients who received that chemotherapy plus VCN-01 had a median overall survival of 10.8 months.

The improvements in overall survival in the VCN-01 treatment arm were reflected in increased progression-free survival, the company says. Further, the median duration of response doubled in the treatment arm.

The increase in overall survival was greater for patients who received two doses of VCN-01 and four or more cycles of standard of care chemotherapy, Theriva says.

The company says it will work on developing a Phase 3 trial, having received recent advice from FDA and the European Medicines Agency.

VCN-01 is described as a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. It has received FDA orphan drug and fast-track designations.