GeoVax Expands Gedeptin® Clinical Research for Advanced Head and Neck Cancers
February 07 2023 - 9:00AM
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 GeoVaxGeoVax 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
Turett914-434-0311nmturett@geovax.com
Investor Relations Contact:Rich CockrellCG
Capital404-736-3838govx@cg.capital
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