CARLSBAD, Calif., Aug. 31, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN) announced today it has signed
a contract with IRISYS LLC for the production of AS1411, Qualigen's
lead drug candidate for the treatment of viral diseases including
COVID-19. Preclinical studies at the University of Louisville's (UofL) prestigious
Center for Infectious Disease have demonstrated the ability of
AS1411 to protect cells from the damaging effects of the novel
coronavirus by binding to the nucleolin protein.
"This manufacturing contract represents a key step in our
development of AS1411 as an antiviral therapeutic and ensures the
availability of this drug beyond our IND-enabling studies for the
treatment of COVID-19," said Michael
Poirier, President, Chief Executive Officer and Chairman of
Qualigen. "Although we're still in the preclinical stage in
this indication, we know AS1411 is safe in humans as it has been
administered in Phase 1 and Phase 2 trials to more than 100
patients with advanced cancers. It was well tolerated with no
evidence of severe side effects, and the maximum tolerated dose of
the drug was never reached. We look forward to advancing AS1411
toward and in the clinic for COVID-19, and in the future
investigating other applications due to the potential ability of
AS1411 to be effective as a broad antiviral therapeutic."
AS1411 targets and binds to a protein called nucleolin, which
plays a role in how viruses attack and utilize cells for
replication. In June 2020,
Qualigen signed an exclusive license agreement with UofL for the
U.S. patent rights covering the treatment of COVID-19 with AS1411.
Qualigen intends to work with the UofL to complete investigational
new drug (IND)-enabling studies 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 early next year.
About IRISYS LLC
IRISYS was founded in 1996 to provide
contract pharmaceutical product development and manufacturing
services, specializing in formulation development, cGMP
manufacturing of clinical trial materials and commercial
pharmaceutical products on a global basis. Its headquarters,
including laboratories and state-of- the-art manufacturing
facility, is located in San Diego,
California.
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 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 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 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.