TYME Granted U.S. Patent Claims Covering Use of TYME-19 to Treat COVID-19 Infections
February 03 2021 - 8:00AM
Business Wire
Tyme Technologies, Inc. (NASDAQ: TYME), an emerging
biotechnology company developing cancer metabolism-based therapies
(CMBTs™), announced that it has received notification that the
United States Patent and Trademark Office has granted additional
patent claims related to the Company’s metabolomic technology
platform. The patent, U.S. Patent No. 10,905,698, is directed to
methods for treating COVID-19.
Unlike immune therapies that depend upon the structure of the
external virus coat of COVID-19 where the therapy directs its
attack, we believe TYME-19 is agnostic to this structure and any
mutations to the viral coat. Like other TYME agents, TYME-19
affects cellular metabolism. It constrains viral replication after
a virus has inserted its genetic blueprint into an infected cell by
inhibiting the ability of the virus to use the cells synthetic
apparatus to make viral proteins and lipids. As a result, we
believe that TYME-19 diminishes the ability of COVID-19 to hijack
an infected cell. TYME intends to initiate the appropriate clinical
trials to substantiate the safety and efficacy of TYME-19.
TYME-19 is an investigational compound that is not approved in
the U.S. for any disease indication.
About TYME-19
TYME-19 is an oral synthetic member of the bile acid family that
the Company also uses in its anticancer compound, TYME-18. Because
of its expertise in metabolic therapies, the Company was able to
identify TYME-19 as a potent, well characterized antiviral bile
acid and has performed preclinical experiments establishing
effectiveness against COVID-19. Bile acids have primarily been used
for liver disease; however, like all steroids, they are messenger
molecules that modulate a number of diverse critical cellular
regulators. Bile acids modulate lipid and glucose metabolism and
can remediate dysregulated protein folding, with potentially
therapeutic effects on cardiovascular, neurologic, immune, and
other metabolic systems. Some agents in this class also have
antiviral properties. In preclinical testing, TYME-19 repeatedly
prevented COVID-19 viral replication without attributable
cytotoxicity to the treated cells. Previous preclinical research
has also shown select bile acids like TYME-19 have had broad
antiviral activity.
About Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company
developing cancer therapeutics that are intended to be broadly
effective across tumor types and have low toxicity profiles. Unlike
targeted therapies that attempt to regulate specific mutations
within cancer, the Company’s therapeutic approach is designed to
take advantage of a cancer cell’s innate metabolic weaknesses to
compromise its defenses, leading to cell death through oxidative
stress and exposure to the body’s natural immune system.
With the development of TYME-18 and TYME-19, the Company
believes that it is also emerging as a leader in the development of
bile acids as potential therapies for cancer and COVID-19. For more
information, visit www.tymeinc.com. Follow us on social media:
Facebook, LinkedIn, Twitter, YouTube and Instagram.
Forward-Looking Statements/Disclosure Notice
In addition to historical information, this press release
contains forward-looking statements under the Private Securities
Litigation Reform Act that involve substantial risks and
uncertainties. Such forward-looking statements within this press
release include, without limitation, statements regarding our drug
candidates (including SM-88 and TYME- 18) and their clinical
potential and non-toxic safety profiles, our drug development plans
and strategies, ongoing and planned preclinical or clinical trials,
including the proposed TYME-19 proof-of-concept study, preliminary
data results and the therapeutic design and mechanisms of our drug
candidates. The words “believes,” “expects,” “hopes,” “may,”
“will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,”
“continue,” “seeks,” “anticipates,” and similar expressions
(including their use in the negative) are intended to identify
forward-looking statements. Forward-looking statements can also be
identified by discussions of future matters such as: the effect of
the novel coronavirus (COVID-19) pandemic and the associated
economic downturn and impacts on the Company's ongoing clinical
trials and ability to analyze data from those trials; the cost of
development and potential commercialization of our lead drug
candidate and of other new products; expected releases of interim
or final data from our clinical trials; possible collaborations;
and the timing, scope, status, objectives and strategy of our
ongoing and planned trials; the success of management transitions;
and other statements that are not historical. The forward-looking
statements contained in this press release are based on
management’s current expectations and projections which are subject
to uncertainty, risks and changes in circumstances that are
difficult to predict and many of which are outside of our control.
These statements involve known and unknown risks, uncertainties and
other factors which may cause the Company’s actual results,
performance or achievements to be materially different from any
historical results and future results, performance or achievements
expressed or implied by the forward-looking statements. These risks
and uncertainties include but are not limited to: the severity,
duration, and economic and operational impact of the COVID-19
pandemic; that the information is of a preliminary nature and may
be subject to change; uncertainties inherent in the cost and
outcomes of research and development, including the cost and
availability of acceptable-quality clinical supply, and in the
ability to achieve adequate start and completion dates, as well as
uncertainties in clinical trial design and patient enrollment,
dropout or discontinuation rates; the possibility of unfavorable
study results, including unfavorable new clinical data and
additional analyses of existing data; risks associated with early,
initial data, including the risk that the final data from any
clinical trials may differ from prior or preliminary study data;
final results of additional clinical trials that may be different
from the preliminary data analysis and may not support further
clinical development; that past reported data are not necessarily
predictive of future patient or clinical data outcomes; whether and
when any applications or other submissions for SM-88 may be filed
with regulatory authorities; whether and when regulatory
authorities may approve any applications or submissions; decisions
by regulatory authorities regarding labeling and other matters that
could affect commercial availability of SM-88; the ability of TYME
and its collaborators to develop and realize collaborative
synergies; competitive developments; and the factors described in
the section captioned “Risk Factors” of TYME’s Annual Report on
Form 10-K filed with the U.S. Securities and Exchange Commission on
May 22, 2020, as well as subsequent reports we file from time to
time with the U.S. Securities and Exchange Commission available at
www.sec.gov.
The information contained in this press release is as of its
release date and TYME assumes no obligation to update
forward-looking statements contained in this release as a result of
future events or developments.
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