CARLSBAD, Calif., Dec. 2, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN) announces that it has
completed the recertification of its supply of AS1411, and has
begun final formulation and filling for use in the Company's
proposed Phase 2a efficacy trials of AS1411 for the treatment of
patients with COVID-19. Qualigen plans to seek U.S. Food and
Drug Administration (FDA) approval for and to begin these trials in
the first half of calendar 2021.
Qualigen's lead compound AS1411 is a nucleolin-targeting DNA
aptamer drug candidate for the treatment of COVID-19 and other
viruses. Preclinical studies at the University
of Louisville's (UofL) Center for Infectious Disease have
demonstrated the ability of AS1411 to protect cells from the
damaging effects of the novel coronavirus. In addition, AS1411
holds potential as a broad antiviral therapeutic agent, which could
expand its applications and market potential.
"Even with the roll-out of COVID-19 vaccines, we see this virus
being around for many years to come in different forms. The
mechanism by which AS1411 is believed to work, by blocking the
ability of viruses to replicate in the body, may make our
therapeutic effective against future mutations in COVID-19 as well
as against other dangerous viruses including the flu," stated
Michael Poirier, President, Chief
Executive Officer and Chairman of Qualigen.
Mr. Poirier added: "Recertification of our AS1411 inventory
represents another critical step in advancing our antiviral
development program in a cost-efficient manner. We continue
to move forward with our IND-enabling studies and are on track to
commence the efficacy stage of human trials in the first half of
next year, upon obtaining IND approval from the FDA. We believe
there is great potential for this drug to be an effective
therapeutic for COVID-19, in addition to other viral
infections."
In June 2020, Qualigen signed an
exclusive license agreement with UofL for U.S. patent rights
covering the treatment of COVID-19 with AS1411, adding to
Qualigen's other AS1411 license exclusivities. Qualigen intends to
work with UofL to complete investigational new drug (IND)-enabling
studies and plans to file an IND application with the FDA in early
calendar 2021. Qualigen's aim is to initiate a Phase 2a
clinical study in COVID-19 patients in the first half of calendar
2021.
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 FastPack® System, which has been used
successfully in diagnostics for 20 years. The Company's cancer
therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS™.
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 nucleolin-targeting DNA
aptamer of ALAN, AS1411, is also a drug candidate for use in
treating COVID-19 and other viral-based infectious
diseases. 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 potential
future development, testing, efficacy, approval, manufacturing and
commercialization of product candidates, including the possible
effectiveness of AS1411 against COVID-19 or other viral infections
and the approval and timing of clinical trials. 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.