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FAQ: GeoVax's Gedeptin® Clinical Trial Results for Recurrent Head & Neck Cancer
TL;DR
GeoVax's Gedeptin therapy offers a potential edge in treating recurrent head and neck cancers with its repeat-dosing feasibility and tumor-agnostic mechanism for broader application.
Gedeptin uses an adenoviral vector to deliver the PNP gene into tumors, converting systemic fludarabine into a cytotoxic metabolite that kills cancer cells locally.
This therapy provides hope for patients with end-stage head and neck cancer by demonstrating disease stability and a favorable safety profile when other treatments have failed.
Gedeptin's bystander effect allows it to kill neighboring cancer cells even when only a small fraction of the tumor is directly treated.
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GeoVax announced the publication of peer-reviewed results from a Phase 1/2 clinical trial evaluating Gedeptin®, a gene-directed enzyme prodrug therapy, for treating recurrent head and neck cancer, showing favorable safety and evidence of disease stability.
Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) that involves intratumoral injection of the therapy followed by systemic administration of fludarabine phosphate, with tumor biopsies confirming successful tumor transduction and expression of the therapeutic E. coli PNP transgene.
The trial demonstrated an acceptable safety profile with no new safety signals, clinical evidence of disease stability in 37.5% of patients, and successful tumor transduction with PNP transgene expression in all evaluable patients.
These results are significant because they show promise in a highly refractory patient population who had exhausted all standard treatment options, supporting continued development in earlier-stage disease and combination strategies that could improve outcomes.
GeoVax Labs conducted this multi-center clinical trial, and the results were published in JCO Oncology Advances, the American Society of Clinical Oncology's open-access journal.
The trial enrolled patients with recurrent head and neck cancers who had exhausted all standard treatment options and had undergone a median of four prior lines of systemic therapy.
GeoVax plans to advance Gedeptin® into neoadjuvant studies for surgically resectable recurrent head and neck cancers and explore combination strategies, particularly with immune checkpoint inhibitors, to amplify therapeutic benefit.
Gedeptin® represents a novel gene-directed enzyme prodrug therapy approach that showed safety and disease stability in patients who had already failed multiple prior treatments, offering a targeted mechanism with repeat-dosing feasibility.
According to the study, earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy with immune checkpoint inhibitors may further increase efficacy, with preclinical findings showing Gedeptin may sensitize tumors to checkpoint inhibitors.
Curated from NewMediaWire
