CARLSBAD, Calif., Dec. 15, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company
focused on developing novel therapeutics for the treatment of
cancer and infectious diseases, today announced that the United
States Patent and Trademark Office has issued a patent entitled
"Anti-Nucleolin Agent-Conjugated Nanoparticles as Radio-Sensitizers
and/or MRI Contrast Agents" regarding the Company's ALAN
(Aptamer-Linked Anti-Nucleolin) technology. This patent
issued to the University of Louisville
(UofL) protects the ALAN technology for use with cancer radiation
therapy and for imaging tumors utilizing magnetic resonance imaging
(MRI). The novel ALAN technology has several other potential
applications, including its use as a monotherapy for the treatment
of cancer and as a vehicle to deliver other anticancer compounds
directly to tumors. In 2018, Qualigen obtained exclusive worldwide
rights from the UofL for the use of the ALAN technology.
The gold nanoparticle component of ALAN is believed to enhance
radiation therapy by "magnifying" the effects of radiation on the
targeted tumor cells with the potential to justify lower radiation
exposure and, in turn, decrease side effects. ALAN may also
potentially be used in combination with MRIs to provide
higher-resolution images of solid tumors and tumor cells as special
imaging dyes attach to the gold nanoparticle compound.
"With the issuance of this patent, we continue to build our
intellectual property portfolio as a key component to protect our
technologies under development," stated Michael Poirier, Qualigen's Chairman, Chief
Executive Officer and President. "ALAN is a valuable therapeutic
platform technology that may be applied in numerous indications.
Currently, we are evaluating strategic options on how to develop
and monetize these additional applications while we continue to
advance ALAN in our development pipeline against acute myeloid
leukemia."
ALAN is a DNA aptamer-based anticancer drug candidate that
combines the DNA aptamer AS1411 with a gold nanoparticle to
dramatically increase its potency. This drug candidate has the
potential to target and destroy tumor cells in a wide variety of
cancer types with minimal side effects. The Company plans to
commence Phase 1 human trials with ALAN in 2021 in patients with
acute myeloid leukemia, its lead indication.
"The issuance of this patent for ALAN further protects this
technology's potential broad applicability as a treatment for
cancer," added Paula Bates, PhD,
Professor of Medicine at UofL. "We look forward to our continued
collaboration with Qualigen as we plan to enter this drug candidate
into clinical trials as a therapeutic next year. We believe ALAN
has the potential to be more targeted than available cancer
treatments with the ability not to harm normal healthy cells
resulting in less side effects for the patient."
Qualigen currently has 58 issued and pending patents and has
in-licensed rights to a further 42 issued and pending patents.
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 prospects
for ALAN, and the timing of the Company's proposed Phase 1 clinical
trial of ALAN against acute myeloid leukemia. 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 (or ALAN for imaging); that preclinical or clinical
development of the Company's drugs or therapeutic devices (or
ALAN for imaging) 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 (or ALAN for imaging) 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 (or ALAN
for imaging); that the Company will be able to maintain or expand
market demand and/or market share for the Company's FastPack
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.