CARLSBAD, Calif., Nov. 5, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN) announced today it has signed
a contract with STA Pharmaceutical Co., Ltd. (WuXi STA), a
subsidiary of WuXi AppTec, for GMP production of AS1411, Qualigen's
lead drug candidate for the treatment of COVID-19 and other viral
diseases, for potential clinical trials. Preclinical studies
at the University of Louisville's
(UofL) Center for Infectious Disease have demonstrated the ability
of AS1411, a novel aptamer-based molecule, to protect cells from
the damaging effects of the novel coronavirus.
"With its industry leading large-scale oligonucleotide
manufacturing capability, this new manufacturing contract with WuXi
STA will ensure we have adequate supply of AS1411 for our
anticipated clinical trials in patients with COVID-19.
Securing multisource manufacturing capacity is an integral
part of our planning for this potential broad antiviral
therapeutic," said Michael Poirier,
President, Chief Executive Officer and Chairman of Qualigen.
"Given the persistence of the pandemic, there continues to be a
need to develop treatments for COVID-19. We are encouraged by the
AS1411 preclinical data indicating potential effectiveness against
SARS-CoV-2, the novel coronavirus that causes COVID-19. Moreover,
AS1411 has a strong safety profile as it was previously
administered to more than 100 patients with advanced cancers and
was well tolerated with no evidence of severe side
effects."
In June 2020, Qualigen signed an
exclusive license agreement with UofL for U.S. patent rights
covering the treatment of COVID-19 with AS1411. Qualigen intends to
work with 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 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 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 nucleolin-targeting DNA
aptamer of ALAN, AS1411, is also being studied as 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 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), and the
availability and adequacy of supply of AS1411 for anticipated
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 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.