Qualigen Therapeutics, Inc. Announces Submission of Investigational New Drug (IND) Application for QN-165, for the Treatment ...
July 14 2021 - 7:30AM
Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company
focused on developing novel therapeutics for the treatment of
cancer and viral diseases, announced today the submission of an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA) for Qualigen's QN-165 with an initial
target indication for the treatment of COVID-19 in hospitalized
patients. QN-165, a DNA aptamer, is a broad-based antiviral drug
candidate that has exhibited antiviral activity in multiple in
vitro assays against different viruses.
“We are excited to have reached this important
milestone of submitting our first IND application to the FDA on our
most advanced therapeutics program. This submission of the IND
application for Phase 1b/2a clinical trials for QN-165 represents
another step in our evolution from a globally patented and
commercially successful diagnostics company to a clinical-stage
therapeutics company with multiple programs,” stated Michael
Poirier, Chairman and Chief Executive Officer at Qualigen
Therapeutics.
Poirier added, “QN-165 is a unique drug
candidate that has a completely different approach to attacking a
virus, which we think will enable it to work against all virus
strains and variants. QN-165 is a piece of synthetic DNA that does
not attack the coronavirus directly. Instead, it targets and binds
to the nucleolin protein and can enter cells that overexpress
nucleolin. Viruses such as SARS-CoV-2 exploit nucleolin to gain
access to a cell and manipulate it for its own viral replication
purposes. We believe that QN-165, by tying up nucleolin, blocks
that mechanism and prevents the virus replication process.
Therefore, even if the virus mutates, we do not expect this to
decrease the effectiveness of QN-165. The reason is that QN-165
targets nucleolin instead of the virus itself. We believe that this
approach will set QN-165 apart and has the potential for QN-165 to
be proven effective against a multitude of viral mutations,
including all of the strains and variants of the novel
coronavirus.”
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. Our cancer
therapeutics pipeline includes QN-247, RAS-F, and STARS™. QN-247
(formerly referred to as ALAN) is a DNA coated gold nanoparticle
cancer drug candidate that has the potential to target various
types of cancer with minimal side effects; the nanoparticle coating
technology is similar to the core nanoparticle coating technology
used in our blood-testing diagnostic products. The foundational
aptamer of QN-247, QN-165, is also a drug candidate for treating
COVID-19 and other viral-based infectious diseases; we currently
plan that our first therapeutics clinical trial would be the trial
of QN-165 for treatment of COVID-19 in hospitalized patients.
(QN-165 was formerly referred to as AS1411.) 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.
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 Company's prospects
and strategy for the development of therapeutic drug candidates and
the potential focused and general effectiveness of QN-165 against
viruses. Actual events or results may differ from the Company's
expectations. For example, there can be no assurance that the FDA
will approve the Company’s IND application, soon or at all; that
clinical trials (including the contemplated QN-165 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 QN-165 will be demonstrated to be safe and
effective against either the initial version of SARS-CoV-2 or of
any other virus, or against any strains or variants thereof; 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; or that
the Company will be able to maintain or expand market demand and/or
market share for the Company's diagnostic products. 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 can be found in the
Company's prior filings with the Securities and Exchange
Commission, including its most recent Form 10-K, all of which
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.
Investor Relations:For further
information: David KugelmanAtlanta Capital Partners, LLC(404)
856-9157 or (866) 692-6847 Toll Free - U.S. &
Canadadk@atlcp.com
Tony SchorInvestor Awareness, Inc.(847)
971-0922tony@investorawareness.com
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