Researchers from GeoVax Labs have unveiled encouraging clinical data for Gedeptin®, a groundbreaking gene-directed enzyme prodrug therapy designed to target solid tumors, at the American Association for Cancer Research (AACR) Annual Meeting in Chicago.
The Phase 1/2 clinical trial focused on patients with advanced head and neck cancers, evaluating the safety and efficacy of a unique therapeutic approach that combines intratumoral Gedeptin® injections with intravenous fludarabine administration. The study enrolled eight heavily pretreated patients who had undergone a median of four prior systemic therapy lines, indicating the challenging nature of their cancer progression.
Key findings from the trial demonstrated notable clinical potential. Patients participating in the study achieved stable disease despite extensive prior treatments, with median progression-free and overall survival periods of 7.0 months. Critically, the treatment showed minimal toxicity, with no dose-limiting adverse events and only mild side effects such as injection site pain.
The innovative therapy works by using a non-replicating adenoviral vector encoding a bacterial enzyme that selectively converts a prodrug into a cytotoxic compound, effectively targeting cancer cells while minimizing damage to healthy tissue. This precise mechanism allows for potentially more effective treatment of challenging solid tumors.
Following these promising results, GeoVax is preparing to launch a Phase 2 clinical trial exploring Gedeptin® in combination with pembrolizumab, an immunotherapy drug. Preclinical research suggests this combination could enhance immune system response against tumors, representing a significant advancement in cancer treatment strategies.
The research highlights the potential of targeted gene therapies in oncology, offering hope for patients with advanced cancers that have proven resistant to conventional treatments. By focusing on precise molecular mechanisms, Gedeptin® represents an innovative approach to cancer therapy that could potentially improve patient outcomes and quality of life.
