GeoVax Retains CATO SMS To Manage Gedeptin Phase 1/2 Clinical Trial

GeoVax Labs, Inc. GOVX, a biotechnology company specializing in developing human vaccines and cancer immunotherapies, today announced the engagement of CATO SMS to manage GeoVax's ongoing Phase 1/2 trial, evaluating the safety and efficacy of repeat cycles of Gedeptin® therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC). Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a very toxic antitumor compound. A cycle of Gedeptin therapy consists of three intra-tumoral injections of Gedeptin over a two-day period 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. The Phase 1/2 trial, evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent HNSCC, with tumor(s) accessible for injection and no curable treatment options, is currently enrolling at Stanford University. Efforts are also advancing quickly to open at least two additional study sites in support of accelerated trial enrollment. The initial stage of the study is being funded 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. David Dodd, GeoVax President and CEO, commented, "We are excited to have engaged CATO SMS as our CRO partner for our Gedeptin program. We have been impressed by the breadth of oncology expertise and professionalism of the CATO SMS team and look forward to working with them to achieve our clinical milestones including the expansion of clinical sites and acceleration of patient enrollment and evaluation. We look forward to providing timely updates regarding the progress of the Gedeptin clinical program."