Theriva™ Biologics, Inc. (NYSE American: TOVX), a clinical-stage company developing therapies to treat cancer and related diseases, has announced that it has achieved its patient enrollment goal in its Phase 2b clinical trial, VIRAGE. This trial evaluates VCN-01, an oncolytic adenovirus, in combination with standard chemotherapy (gemcitabine/nab-paclitaxel) as first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
In the trial, a total of 92 evaluable patients were enrolled, evenly distributed in the control and VCN-01 treatment arms, in 15 centers in Spain and the United States within a 21-month period. The FDA has granted VCN-01 orphan drug and fast track designation for the treatment of PDAC.
“We are delighted to have achieved enrollment goal for our Phase 2b VIRAGE trial for metastatic PDAC,” said Steven A. Shallcross, CEO of Theriva Biologics. Shallcross emphasized the interest of physicians and the urgent need for an effective treatment for this disease.
PDAC represents more than 90% of pancreatic tumors and is generally diagnosed in advanced stages when surgical and curative options are limited. This underscores the importance of developing effective treatments like VCN-01, which has a unique mode of action allowing it to target tumor cells, enhance the effectiveness of co-administered chemotherapy, and expose tumors to the patient’s immune system.
The VIRAGE clinical trial is being conducted in 16 centers in the US and Europe, with patients receiving standard chemotherapy in 28-day cycles. Patients in the treatment arm also receive intravenous doses of VCN-01 before certain chemotherapy cycles. Evaluation criteria include overall survival, safety and tolerability of VCN-01, as well as other measures related to viral replication and immune response.
Theriva Biologics is committed to developing innovative therapies and has expanded the use of VCN-01 to over 80 patients in various Phase 1 clinical trials and investigator-sponsored studies for other types of cancer. The company states that advancements from their clinical trials, like VIRAGE, could lead to improved outcomes in PDAC treatment and potentially other cancers.
As for the company, Theriva™ Biologics specializes in developing oncolytic adenoviruses designed for safe and effective administration, with multiple antitumor effects. In addition to VCN-01, the product portfolio includes SYN-004 and SYN-020 for various indications.
This advancement highlights the potential of new therapies in the fight against cancer and reflects the company’s dedication to addressing urgent and unmet medical needs. The company will continue to report on the progress and results of the trial as new information becomes available.
Referrer: MiMub in Spanish
