CARLSBAD, Calif., Sept. 17, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN) announces its and the
University of Louisville's joint filing
of a United States provisional
patent application, entitled "Methods of inhibiting or treating
coronavirus infection, and methods for delivering an anti-nucleolin
agent." The application was filed in conjunction with Drs.
Paula J. Bates and Kenneth E. Palmer from the University of Louisville, and covers methods for
using the antiviral drug candidate AS1411 to prevent SARS-CoV-2
(the virus that causes COVID-19) from entering the body through
mucous membranes in the nose, mouth and eyes.
As stated in the patent application, Qualigen believes that
AS1411 could be administered by means of inhalers, nose spray or
eye drops to individuals who have recently come in contact with
SARS-CoV-2, or are at high risk of contracting the virus. As
such, AS1411 could serve as a protective defense or prophylaxis
against this and possibly other viral-based diseases such as
seasonal influenza.
"This provisional patent application, if granted, would provide
Qualigen with additional intellectual property protection for an
expanded use of AS1411 and other nucleolin-binding DNA aptamers not
only to treat viral infections like COVID-19, but also to prevent
such diseases in the first place by stopping the viruses from
infecting and doing damage to the lungs and other vital areas of
the body," stated Michael Poirier,
President, Chief Executive Officer and Chairman of Qualigen. "While
this is still an early hypothesis, virus infection prevention
represents a very broad and exciting application for our
technology."
Qualigen intends to work with the University of Louisville to complete
investigational new drug (IND)-enabling studies of AS1411 as a
therapeutic against COVID-19 and plans to file an IND application
with the U.S. Food and Drug Administration in the fourth quarter of
2020. The intent is to commence Phase 1/2 clinical studies in
COVID-19 patients in early 2021. The Company plans to collaborate
with the University of Louisville to
further study the possible separate use of AS1411 for virus
infection prevention.
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 almost 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 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 possible effectiveness of AS1411 as a
prophylaxis against COVID-19 or other viral diseases, the
possibility of patent protection for such use, 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). 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.