GeoVax Labs, Inc. announced the closure of patient enrollment for the Phase 1/2 clinical study evaluating Gedeptin®? in patients suffering from advanced head and neck cancer. The protocol entails up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days.

A completed Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors. A previously reported interim data review demonstrated: No dose limiting toxicities or serious adverse events (SAEs) are definitively attributable to treatment. Impairment of tumor growth (i.e., "stable disease" using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study.

The current 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 intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.