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Theriva™ Biologics, Inc. has announced the preliminary results of its Phase 2b clinical trial, VIRAGE, which evaluates the product candidate VCN-01 (zabilugene almadenorepvec) in combination with standard chemotherapy for patients with metastatic ductal pancreatic adenocarcinoma (PDAC). This novel treatment aims to provide an improved therapeutic alternative compared to the standard gemcitabine/nab-paclitaxel regimen.
The data obtained from the study reveal that patients treated with VCN-01, in combination with chemotherapy, showed a significant increase in overall survival, progression-free survival, and duration of response. In the primary analysis, the median overall survival for those receiving only standard chemotherapy was 8.6 months, while for those who also received VCN-01, this figure rose to 10.8 months. This result translates to a hazard ratio of 0.57, indicating a positive impact from the new treatment.
Furthermore, progression-free survival showed similarly favorable results, with a median of 7.0 months in the group receiving VCN-01 compared to 4.6 months in the control group. The duration of response was notable in the VCN-01 group, reaching 11.2 months, double the 5.4 months observed in the control group.
The analysis suggests that administering two doses of VCN-01, alongside four cycles of chemotherapy, resulted in an average survival of 14.8 months, indicating that this combination treatment could provide significant benefits for patients.
The side effects associated with the use of VCN-01 were generally transient and similar to those observed in previous treatments, suggesting an acceptable safety profile for the drug.
Theriva has also announced a scheduled virtual event on May 7, 2025, where these results will be discussed. This event will feature pancreatic oncology experts who will analyze the findings and the future of treatment for this aggressive disease.
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Source: MiMub in Spanish