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GeoVax Expands Gedeptin® Clinical Research for Advanced Head and Neck Cancers
Phase 1/2 Trial Now Active at Stanford, Emory, and Thomas Jefferson Universities ATLANTA, GA, Feb. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax
About this update from Geovax Labs, Inc.
[{"type":"text","content":"Phase 1/2 Trial Now Active at Stanford, Emory, and Thomas Jefferson Universities ATLANTA, GA, Feb. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today its clinical trial of Gedeptin® for patients with recurrent head and neck cancers is now actively enrolling patients at three major research centers -- Stanford University, Emory University and Thomas Jefferson University. The Phase 1/2 trial (NCT03754933) is evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol entails up to five treatment cycles, each consisting of three intra-tumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. A Phase 1 dose-ranging study, evaluating the safety of a single cycle of Gedeptin therapy, found the therapy to be well-tolerated, with evidence of a reduction in tumor size in patients with solid tumors. David Dodd, GeoVax President and CEO, commented, “The support of the FDA and collaborations with Stanford, Emory and Jefferson enable us to evaluate Gedeptin rapidly in 10 patients, with the potential to subsequently expand the trial to 25 patients. A successful outcome may lead to labeling discussions with the FDA and initiation of further Gedeptin investigations, including in combination with immune checkpoint inhibitors, for additional cancerous and non-cancerous tumor indications.” The study is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities. About GeoVaxGeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 cli...