Theriva Secures IDMC Recommendation For Enrollment in Phase 2b Trial

Theriva Biologics, a broadened clinical-stage organization creating therapeutics intended to treat malignant growth and related sicknesses in areas of high neglected need, declared that the Free Information Observing Panel (IDMC) suggested the continuation of enlistment as arranged into VIRAGE, a global, stage 2b, randomized, open-mark, controlled clinical preliminary assessing VCN-01 in mix with standard-of-care chemotherapy (gemcitabine/grab paclitaxel) as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

According to the IDMC's comprehensive assessment of clinical data from patients enrolled across 6 sites open in the US and 9 sites open in Spain, the ongoing phase 2b trial will continue without any changes to the protocol. No safety concerns were raised based on the evaluation of data presented at the IDMC meeting. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials. 

Most importantly, patients who received a second dose of VCN-01 experienced no additional side effects, providing the first clinical evidence of the viability of repeated systemic dosing. VIRAGE is still on schedule to finish enrolling students in the first half of 2024.

"The positive IDMC review of VCN-01 safety following repeated systemic dosing marks a significant step forward for our lead program. VCN-01 is a highly differentiated, systemic, selective, stroma-degrading oncolytic adenovirus," said Steven A. Shallcross, chief executive officer of Theriva Biologics, a biotechnology company. “With the IDMC’s recommendation, we will continue to drive forward the VIRAGE study and explore the potential of VCN-01 to improve outcomes in first-line metastatic PDAC patients treated with standard-of-care chemotherapy. We have shown that repeated systemic dosing of VCN-01 is feasible from a safety perspective, and can now focus on whether the repeated-dose VCN-01 regimen may lead to improved clinical outcomes for patients with PDAC and other solid cancers.”