Genprex Announces Centralized Institutional Review Board Approval for Acclaim-1 Clinical Trial in Non-Small Cell Lung Cancer
May 05 2021 - 8:55AM
Business Wire
Company achieves another milestone relating to
its clinical trial strategy
Acclaim-1 clinical trial to treat late-stage
NSCLC patients whose disease progressed on Tagrisso®
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, today announced that the Company has received centralized
Institutional Review Board (IRB) approval of the clinical trial
protocol for its upcoming Acclaim-1 clinical trial in non-small
cell lung cancer (NSCLC). Acclaim-1 is an open-label, multi-center
Phase 1/2 clinical trial that combines the Company’s lead drug
candidate, REQORSA™ immunogene therapy, with AstraZeneca’s
Tagrisso® (osimertinib) in patients with late-stage NSCLC with
mutated epidermal growth factor receptors (EGFRs), whose disease
progressed after treatment with Tagrisso.
“The purpose of IRB review is to assure that appropriate steps
are taken to protect the rights and welfare of individuals
participating as subjects in clinical research,” said Rodney
Varner, President and Chief Executive Officer of Genprex. “With
this centralized IRB approval, we have achieved another significant
clinical milestone. We remain focused on completing our
preparations for the Acclaim-1 clinical trial, and look forward to
its commencement.”
An IRB is a U.S. Food and Drug Administration (FDA) registered
constituted group of medical professionals that are responsible for
reviewing and monitoring biomedical research involving human
subjects. In accordance with FDA regulations, an IRB has the
authority to approve, require modifications (to secure approval),
or disapprove research. IRB group review serves an important role
in the protection of the rights, safety and welfare of human
research subjects.
A centralized IRB review process involves an agreement under
which multiple study sites in a multicenter trial can rely on the
review of a centralized IRB, other than the IRB affiliated with
each individual research site. The goal of the centralized process
is to increase efficiency and decrease duplicative efforts, while
enabling the central IRB to take responsibility for all aspects of
IRB review at each site participating in the centralized review
process.
In January 2020, the Company received FDA Fast Track Designation
for its Acclaim-1 patient population. Genprex has recently
completed the manufacturing and scaled-up clinical grade production
of REQORSA to supply drug product for its upcoming Acclaim clinical
trials.
The Company expects to conduct the Acclaim-1 clinical trial at
approximately 15 U.S. clinical sites with participation of
approximately 92 patients (with up to 18 patients in the Phase 1
component and up to 74 patients in the Phase 2 component). An
interim analysis will be performed after 25 clinical events (i.e.,
disease progression 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
AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR
mutations whose tumors progressed after treatment with Tagrisso
alone.
For more information, please visit the Company’s web site at
www.genprex.com or follow Genprex on Twitter, Facebook and
LinkedIn.
Cautionary Language Concerning 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. These forward-looking statements are made on the basis of
the current beliefs, expectations and assumptions of management,
are not guarantees of performance and are subject to significant
risks and uncertainty. These forward-looking statements should,
therefore, be considered in light of various important factors,
including those set forth in Genprex’s reports that it files from
time to time with the Securities and Exchange Commission and which
you should review, including those statements under “Item 1A – Risk
Factors” in Genprex’s Annual Report on Form 10-K.
Because forward-looking 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 timing and success of Genprex’s clinical trials and regulatory
approvals; the effect of Genprex’s product candidates, alone and in
combination with other therapies, on cancer and diabetes; Genprex’s
future growth and financial status; Genprex’s commercial and
strategic partnerships including the scale up of the manufacture of
its product candidates; and Genprex’s intellectual property and
licenses.
These forward-looking statements should not be relied upon as
predictions of future events and Genprex cannot assure you that the
events or circumstances discussed or reflected in these statements
will be achieved or will occur. If such forward-looking statements
prove to be inaccurate, the inaccuracy may be material. You should
not regard these statements as a representation or warranty by
Genprex or any other person that Genprex will achieve its
objectives and plans in any specified timeframe, or at all. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Genprex disclaims any obligation to publicly update or release any
revisions to these forward-looking statements, whether as a result
of new information, future events or otherwise, after the date of
this press release or to reflect the occurrence of unanticipated
events, except as required by law.
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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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