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GeoVax Announces Gedeptin Patient Enrollment Closure for Phase 1/2 Clinical Trial Among Advanced Head and Neck Cancer Patients
Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors Expanded Development for Monotherapy and Combination Therapy Anticipated ATLANTA, GA -
About this update from Geovax Labs, Inc.
[{"type":"text","content":"Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors\n \nExpanded Development for Monotherapy and Combination Therapy Anticipated\nATLANTA, GA - (NewMediaWire) - January 04, 2024 - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the closure of patient enrollment for the Phase 1/2 clinical study evaluating Gedeptin(R) in patients suffering from advanced head and neck cancer.\nKelly McKee, MD, MPH, GeoVax's Chief Medical Officer, stated, \"Completion of this trial will be a significant milestone in our Gedeptin clinical development program. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of this year. In the interim, we are in active discussions with advisors on protocol development in support of a follow-on Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal. Our intent is to discuss this follow-on protocol with the FDA, in conjunction with a complete review of the results of the current trial, to ensure alignment with the regulator's expectations. We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway.\"\nDr. McKee continued, \"Demonstrating the safety, tolerability, and stabilization or shrinkage of injected tumors in patients receiving multiple cycles of Gedeptin opens the door to advancing this promising therapeutic in additional patients with advanced head and neck cancer as well as in patients with other solid tumor types and at multiple points in their therapeutic journey.\"\nDavid Dodd, GeoVax's Chairman and CEO, commented, \"We believe that the successful completion of the current trial, in conjunction with earlier findings from the completed Phase 1 first-in-human trial and preclinical investigations, provide a sound rationale for proceeding with further Gedeptin investigations. These will include adjustments to the Gedeptin treatment regimen and combination with immune checkpoint inhibitors in advanced head and neck cancer as well as for additional cancerous and non-cancerous tumor indications. These advances represent a significant potential opportunity for GeoVax to ...