GeoVax Expands Gedeptin® Clinical Research for Advanced Head and Neck Cancers

Rhea-AI Summary

GeoVax Labs (Nasdaq: GOVX) has announced that its Phase 1/2 clinical trial for Gedeptin®, aimed at treating recurrent head and neck cancers, is now actively enrolling patients at Stanford, Emory, and Thomas Jefferson Universities. The trial evaluates the safety and efficacy of Gedeptin with up to five treatment cycles involving intra-tumoral injections. Preliminary results from a prior study indicated that Gedeptin was well-tolerated and showed tumor size reduction. The FDA has granted Gedeptin orphan drug status, which may facilitate further investigations and collaboration in cancer treatment.

Positive

• Phase 1/2 trial for Gedeptin actively enrolling patients at major research centers.
• Previous studies indicated Gedeptin therapy was well-tolerated with evidence of tumor size reduction.
• FDA granted Gedeptin orphan drug status, enhancing its potential marketability.

Negative

• None.

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 GeoVax
GeoVax 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 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a single-dose COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who has driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Media Relations Contact:
Nancy Turett
914-434-0311
nmturett@geovax.com

Investor Relations Contact:
Rich Cockrell
CG Capital
404-736-3838
govx@cg.capital

FAQ

What is the purpose of the Gedeptin trial by GeoVax?

The trial aims to evaluate the safety and efficacy of Gedeptin in patients with recurrent head and neck squamous cell carcinoma.

When does the GeoVax Gedeptin trial start?

The trial is now actively enrolling patients, as of February 7, 2023.

Where is the Gedeptin trial being conducted?

The trial is being conducted at Stanford University, Emory University, and Thomas Jefferson University.

What is the significance of Gedeptin's orphan drug status?

Orphan drug status from the FDA may expedite the development and market approval process for Gedeptin.

What were the results of the previous studies on Gedeptin?

Previous studies showed Gedeptin was well-tolerated and resulted in a reduction of tumor size in some patients.