Genprex Initiates Site Recruitment for Acclaim-1 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer
November 30 2020 - 2:05PM
Business Wire
Acclaim-1 trial combines REQORSA™ immunogene
therapy drug with AstraZeneca’s Tagrisso®
Company expects to recruit approximately 10
sites across the United States
Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a
clinical-stage gene therapy company focused on developing
life-changing therapies for patients with cancer and diabetes, is
pleased to announce it has commenced clinical trial site
recruitment for its upcoming Acclaim-1 clinical trial for the
treatment of non-small cell lung cancer (NSCLC). As planned, the
timing of the patient recruitment and enrollment puts the Company
on track for its Acclaim-1 clinical trial to commence in the
first-half of 2021.
Acclaim-1 is an open-label, multi-center Phase 1/2 clinical
trial that combines Genprex’s lead drug candidate, REQORSA™
immunogene therapy with AstraZeneca PLC’s Tagrisso in patients with
late stage NSCLC with mutated epidermal growth factor receptors
(EGFRs), whose disease progressed after treatment with Tagrisso.
Genprex received U.S. Food and Drug Administration (FDA) Fast Track
Designation for its Acclaim-1 patient population in January of
2020.
“Our clinical team is engaging with prestigious cancer centers
and research institutions across the U.S. to ensure we select
optimal study sites, which play an important role in the success of
a clinical trial,” said Rodney Varner, President and Chief
Executive Officer of Genprex. “We look forward to working with
leading clinical investigators who will help drive our mission to
bring forth a treatment for advanced lung cancer patients.”
The Company plans to conduct the Acclaim-1 clinical trial in
approximately 10 U.S. sites with about 100 patients (9-18 patients
in the Phase 1 component and 82 patients in the Phase 2 component).
An interim analysis will be performed after 53 events (i.e.,
progression of disease or death).
Additional information on the Acclaim-1 clinical trial can be
found by visiting ClinicalTrials.gov.
About Genprex, Inc. Genprex, Inc. is a clinical-stage
gene therapy company focused on developing life-changing therapies
for patients with cancer and diabetes. Genprex’s technologies are
designed to administer disease-fighting genes to provide new
therapies for large patient populations with cancer and diabetes
who currently have limited treatment options. Genprex works with
world-class institutions and collaborators to develop drug
candidates to further its pipeline of gene therapies in order to
provide novel treatment approaches. The Company’s lead product
candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated
as a treatment for non-small cell lung cancer (NSCLC). REQORSA has
a multimodal mechanism of action that has been shown to interrupt
cell signaling pathways that cause replication and proliferation of
cancer cells; re-establish pathways for apoptosis, or programmed
cell death, in cancer cells; and modulate the immune response
against cancer cells. REQORSA has also been shown to block
mechanisms that create drug resistance. In January 2020, the U.S.
Food and Drug Administration granted Fast Track Designation for
REQORSA for NSCLC in combination therapy with osimertinib
(AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose
tumors progressed after treatment with osimertinib alone.
For more information, please visit the Company’s web site at
www.genprex.com or follow Genprex on Twitter, Facebook and
LinkedIn.
Forward-Looking Statements Statements contained in this
press release regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Because such statements
are subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Such statements include, but are not limited to,
statements regarding the effect of Genprex’s product candidates,
alone and in combination with other therapies, on cancer and
diabetes, regarding potential, current and planned clinical trials,
regarding the Company’s future growth and financial status and
regarding our commercial partnerships and intellectual property
licenses. Risks that contribute to the uncertain nature of the
forward-looking statements include the presence and level of the
effect of our product candidates, alone and in combination with
other therapies, on cancer; the timing and success of our clinical
trials and planned clinical trials of REQORSA™ immunogene therapy
drug, alone and in combination with targeted therapies and/or
immunotherapies, and whether our other potential product
candidates, including GPX-002, our gene therapy in diabetes,
advance into clinical trials; the success of our strategic
partnerships, including those relating to manufacturing of our
product candidates; the timing and success at all of obtaining FDA
approval of REQORSA and our other potential product candidates
including whether we receive or benefit from fast track or similar
regulatory designations; costs associated with developing our
product candidates, whether we identify and succeed in acquiring
other technologies and whether patents will ever be issued under
patent applications that are the subject of our license agreements
or otherwise. These and other risks and uncertainties are described
more fully under the caption “Risk Factors” and elsewhere in our
filings and reports with the United States Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were made. We
undertake no obligation to update such statements to reflect events
that occur or circumstances that exist after the date on which they
were made.
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Genprex, Inc. (877) 774-GNPX (4679)
Investor Relations GNPX Investor Relations (877) 774-GNPX
(4679) ext. #2 investors@genprex.com
Media Contact Genprex Media Relations Kalyn Dabbs (877)
774-GNPX (4679) ext. #3 media@genprex.com
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