CARLSBAD, Calif., Oct. 28, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN) today announced receipt of
written feedback to its Type B Pre-IND (Pre-Investigational New
Drug application) meeting request from the U.S. Food and Drug
Administration (FDA) that is in general agreement with the
Company's planned clinical development of AS1411, a
nucleolin-targeting DNA aptamer drug candidate, for the treatment
of COVID-19.
The FDA's response solidifies Qualigen's intention to
reprioritize its clinical development program and to first advance
AS1411 into clinical trials (for treatment of COVID-19) in the
first half of calendar 2021, to be followed next by seeking to
advance ALAN into clinical trials against acute myeloid
leukemia. ALAN is AS1411 attached to a gold nanoparticle.
"We are delighted with the FDA's thoughtful and thorough
response to our Pre-IND meeting request which provides a pathway
for us to move forward with filing the IND application and
initiation of a clinical trial in the first half of calendar 2021,"
stated Michael Poirier, President,
Chief Executive Officer and Chairman of Qualigen. "We are in
agreement with the FDA's additional recommendations and believe
their responses provided the clarity needed to move forward to get
AS1411 into clinical trials for the treatment of hospitalized
patients with COVID-19. In addition, we look forward to
further investigating the potential use of AS1411 as a broader
spectrum antiviral therapeutic."
In its Pre-IND meeting request, the Company requested regulatory
guidance on its planned randomized, multicenter study to evaluate
the safety and efficacy of AS1411 in hospitalized patients with
COVID-19. The FDA's recommendation is to commence with a
Phase 2a proof-of-concept study to evaluate safety and initial
efficacy in determining the appropriate dose with outcomes assessed
at Day 28. The Company and the FDA agree that a Phase 1 clinical
trial is not needed here, because in a previous clinical trial
against cancer AS1411 has already been shown to meet Phase 1 safety
requirements.
"There continues to be a need for novel treatments for
COVID-19," stated Paula Bates, PhD,
Professor of Medicine at the University of
Louisville, who co-invented the technology. "We know that
nucleolin plays an important role in the infectivity of viruses and
were able to demonstrate in our AS1411 preclinical studies, the
aptamer was effective against the SARS-CoV-2 virus at doses
indicated to be safe in humans by previous research. As a result,
we believe AS1411 has the potential to be a promising therapeutic
for COVID-19, as well as for other viral infections."
Extensive preclinical research conducted at the University of Louisville has demonstrated that
AS1411 has potent anti-viral activity against SARS-CoV-2 infection,
the novel coronavirus responsible for COVID-19. Qualigen has held
an exclusive license to AS1411 since 2018, and in June 2020 Qualigen entered into an exclusive
license agreement for the University of
Louisville's pending U.S. patent for the use of AS1411 for
inhibiting or treating COVID-19.
About Qualigen Therapeutics, Inc.
Qualigen
Therapeutics, Inc. is a biotechnology company focused on developing
novel therapeutics for the treatment of cancer and infectious
diseases, as well as maintaining and expanding its core
FDA-approved FastPackĀ® System, which has been used successfully in
diagnostics for almost 20 years. The Company's cancer therapeutics
pipeline includes ALAN (AS1411-GNP), RAS-F and STARSā¢. ALAN
(AS1411-GNP) is a DNA coated gold nanoparticle cancer drug
candidate that has the potential to target various types of cancer
with minimal side effects. The foundational aptamer of ALAN,
AS1411, is also being studied for use in treating or even
preventing viral-based infectious diseases, including
COVID-19. RAS-F is a family of RAS oncogene
protein-protein interaction inhibitor small molecules for
preventing mutated RAS genes' proteins from binding to their
effector proteins; preventing this binding could stop tumor growth,
especially in pancreatic, colorectal and lung cancers. STARS is a
DNA/RNA-based treatment device candidate for removal from
circulating blood of precisely targeted tumor-produced and viral
compounds. Because Qualigen's therapeutic candidates are still in
the development stage, Qualigen's only products that are currently
commercially available are FastPack System diagnostic instruments
and test kits, used in physician offices, clinics and small
hospitals around the world. The FastPack System menu includes rapid
point-of-care diagnostic tests for cancer, men's health, hormone
function, vitamin D status and antibodies against SARS-CoV-2.
Qualigen's facility in Carlsbad,
California is FDA and ISO Certified and its FastPack product
line is sold worldwide by its commercial partner Sekisui
Diagnostics, LLC. For more information on Qualigen Therapeutics,
Inc., please visit https://www.qualigeninc.com/.
Forward-Looking Statements
This news release contains
forward-looking statements by the Company that involve risks and
uncertainties and reflect the Company's judgment as of the date of
this release. These statements include those related to the timing
of the filing and (if any) acceptance of an IND application for
AS1411 as a therapy against COVID-19 and the timing of the related
clinical trials (if any), and the possible effectiveness of AS1411
against COVID-19 or other viral infections. Actual events or
results may differ from the Company's expectations. For example,
there can be no assurance that clinical trials will be approved to
begin by or will proceed as contemplated by any projected timeline;
that the Company will successfully develop any drugs or therapeutic
devices; that preclinical or clinical development of the Company's
drugs or therapeutic devices will be successful; that future
clinical trial data will be favorable or that such trials will
confirm any improvements over other products or lack negative
impacts; that any drugs or therapeutic devices will receive
required regulatory approvals or that they will be commercially
successful; that patents will issue on the Company's owned and
in-licensed patent applications; that such patents, if any, and the
Company's current owned and in-licensed patents would prevent
competition; that the Company will be able to procure or earn
sufficient working capital to complete the development, testing and
launch of the Company's prospective therapeutic products; that the
Company will be able to maintain or expand market demand and/or
market share for the Company's diagnostic products generally,
particularly in view of COVID-19-related deferral of
patients' physician-office visits and FastPack reimbursement
pricing challenges; that adoption and placement of FastPack PRO
System instruments (which are the only FastPack instruments on
which the Company's SARS-CoV-2 IgG test kits can be run) will
be widespread; that the Company will be able to manufacture the
FastPack PRO System instruments and SARS-CoV-2 IgG test kits
successfully; that any commercialization of the FastPack PRO System
instruments and SARS-CoV-2 IgG test kits will be profitable;
or that the FDA will ultimately approve an Emergency Use
Authorization for the Company's SARS-CoV-2 IgG test. The
Company's stock price could be harmed if any of the events or
trends contemplated by the forward-looking statements fails to
occur or is delayed or if any actual future event otherwise differs
from expectations. Additional information concerning these and
other risk factors affecting the Company's business (including
events beyond the Company's control, such as epidemics and
resulting changes) can be found in the Company's prior filings with
the Securities and Exchange Commission, available
at www.sec.gov. The Company disclaims any intent or
obligation to update these forward-looking statements beyond the
date of this news release, except as required by law. This caution
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
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SOURCE Qualigen, Inc.