Theriva™ Biologics Hits Milestone in Cancer Trial with VCN-01
Successful Patient Enrollment in VIRAGE Phase 2b Trial
Theriva™ Biologics, Inc. (NYSE American: TOVX), a clinical-stage company focused on developing innovative cancer therapies, has announced a significant milestone: the successful enrollment of patients in their VIRAGE Phase 2b trial. With a target of 92 evaluable patients—divided evenly between control and treatment groups—Theriva achieved this goal across 15 sites in the USA and Europe within a swift 21 months. This clinical trial is assessing the efficacy of VCN-01 in combination with gemcitabine/nab-paclitaxel, a standard chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (PDAC).
Understanding the Role of VCN-01
At the heart of this trial is VCN-01, an oncolytic adenovirus engineered to selectively target and destroy cancer cells while also breaking down the stroma around tumors—this dense tissue can inhibit treatment effectiveness. VCN-01 possesses Orphan Drug and Fast Track Designations from the FDA, underlining its potential as a groundbreaking treatment for a cancer type with drastically limited options.
Statements from Leadership
Steven A. Shallcross, CEO of Theriva Biologics, shared his enthusiasm regarding the trial's progress. "Achieving our target enrollment showcases not only the interest from the medical community but also highlights an urgent need for effective therapeutic options against metastatic PDAC. We are eager to engage with regulatory bodies to outline the next steps for VCN-01's clinical development, particularly regarding the potential for interim data analysis,” he stated.
Insights into Metastatic Pancreatic Cancer
Pancreatic cancer is notoriously aggressive and often diagnosed at advanced stages, making treatment particularly challenging. The majority of patients present with either advanced local or metastatic disease, compromising surgical options and typical treatment outcomes. The prognosis remains grim, with only a small fraction of patients being eligible for resection upon diagnosis. With the high rate of metastasis, often to the liver and other organs, innovative treatments like VCN-01 are essential to improve survival rates and quality of life for affected individuals.
The VIRAGE Trial's Structure and Objectives
The VIRAGE study is meticulously designed to assess the safety and efficacy of VCN-01 when combined with standard chemotherapy for newly diagnosed metastatic PDAC patients. Participants receive treatment in a controlled manner: the chemotherapy regimen is administered every 28 days, while the experimental arm receives additional doses of VCN-01. Key to the trial’s success will be evaluating overall survival and safety, alongside progression-free survival and response rates—crucial metrics for any prospective therapy in oncology.
Previous Clinical Experiences with VCN-01
Before this trial, VCN-01 was tested in various cancer types, showcasing promise in Phase 1 studies involving over 80 participants. Its dual action—infecting tumor cells while enhancing chemotherapy delivery—offers a unique approach within cancer therapy, spotlighting the need for further exploration in future oncology protocols.
About Theriva™ Biologics, Inc.
As a leader in cutting-edge cancer therapeutics, Theriva™ Biologics maintains a robust pipeline aimed at addressing significant unmet medical needs. Their dedication involves both oncolytic virus methodologies and novel treatment combinations to foster patient responses against numerous cancer types. Their leading candidates, including VCN-01, aspire to create meaningful advancements in patient care, leveraging innovative processes to ensure enhanced outcomes.
Frequently Asked Questions
What is the VIRAGE Phase 2b Trial about?
The VIRAGE trial evaluates VCN-01 combined with chemotherapy for metastatic pancreatic cancer, aiming for significant treatment advancements.
How does VCN-01 work?
VCN-01 is an oncolytic adenovirus that selectively infects tumor cells and degrades surrounding stroma, enhancing treatment efficacy.
What challenges does pancreatic cancer present?
Pancreatic cancer is often diagnosed late, limiting surgical options, and leads to metastasis quickly; new treatments are urgently needed.
What are the key endpoints of the VIRAGE trial?
Primary endpoints include overall survival rates and safety of VCN-01, with additional measures assessing progression-free survival and immune response.
What does Theriva Biologics focus on?
Theriva Biologics specializes in developing therapies for high unmet medical needs, particularly in oncology, utilizing innovative drug platforms.
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