GeoVax Retains CATO SMS to Manage Gedeptin® Phase 1/2 Clinical Trial
January 13 2022 - 9:00AM
via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: 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.”
About CATO SMS
CATO SMS is a global provider of clinical research solutions,
including strategic consulting, full-service clinical trial
operations, biometrics, and clinical pharmacology. With more than
30 years of experience focusing on the needs of small and emerging
biopharmaceutical companies, CATO SMS effectively designs and
executes studies — from strategy to approval — in complex
indications and modalities across a variety of therapeutic areas
with a proven center of excellence in oncology. CATO SMS’
regulatory, therapeutic and operational expertise enables the
company to meet goals and exceed expectations.
Visit CATO-SMS.com for more information.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company
developing human vaccines and immunotherapies against infectious
diseases and cancer using novel proprietary platforms. GeoVax’s
product pipeline includes two ongoing Phase 2 clinical trials of
GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster
vaccine to mRNA vaccines authorized by the U.S. Food and Drug
Administration (FDA) and as a primary vaccine for use in
immunocompromised patients. In addition to GEO-CM04S1 for COVID-19,
GeoVax is developing GEO-CM02 as a pan-coronavirus vaccine. The
Company is also conducting a Phase 1/2 clinical trial of Gedeptin®
for treatment of head and neck cancer. Gedeptin® has been granted
orphan drug status by the FDA. Additional research and development
programs include preventive vaccines against Zika Virus,
hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and
malaria, as well as immunotherapies for multiple solid tumors. The
Company’s portfolio of wholly owned, co-owned, and in-licensed
intellectual property stands at over 70 granted or pending patent
applications spread over 20 patent families.
For additional information about GeoVax, 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 preventive 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 preventive vaccines
with the desired characteristics in a timely manner, GeoVax’s
immuno-oncology products and preventive vaccines will be safe for
human use, GeoVax’s vaccines will effectively prevent targeted
infections in humans, GeoVax’s immuno-oncology products and
preventive 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
registration statement on Form S-3 and the 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 U.S. federal securities
law.
GeoVax Labs, Inc. 6783847220 investor@geovax.com
GeoVax Labs (NASDAQ:GOVXW)
Historical Stock Chart
From Jun 2024 to Jul 2024
GeoVax Labs (NASDAQ:GOVXW)
Historical Stock Chart
From Jul 2023 to Jul 2024