Theriva Biologics (TOVX), Wednesday reported positive topline results from the VIRAGE Phase 2b study evaluating the company's lead drug candidate VCN-01 plus standard-of-care chemotherapy gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
The study met its primary safety endpoint as VCN-01 was well-tolerated, with transient and reversible adverse events. The company's shares were more than 45% up in pre-market.
In the study, 96 newly-diagnosed metastatic PDAC patients were randomized to receive either VCN-01 plus standard-of-care gemcitabine/nab-paclitaxel or gemcitabine/nab-paclitaxel alone.
Data from the study showed that 48 patients treated with at least one dose of gemcitabine/nab-paclitaxel had a median overall survival (OS) of 8.6 months, while the 48 patients treated with VCN-01 followed by at least one dose of gemcitabine/nab-paclitaxel SoC had a median OS of 10.8 months. Median progression free survival (PFS) was 7 months for the VCN-01+SoC treatment arm versus 7 months for SoC control arm. Further, the increase in OS was greater for patients who received 2 doses of VCN-01.
"These data, combined with recent advice from the U.S. FDA and the European Medical Agency, are expected to facilitate engagement with industry partners and enable the design of a Phase 3 confirmatory trial that, if successful, may deliver an important new therapeutic option for patients suffering this rapidly fatal disease," the company said in a statement.
VCN-01 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
Theriva Biologics stock had closed at $1.36, down 2.51% on Tuesday. It has traded in the range of $0.96 - $12.25 in the last 1 year.
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