Atossa Therapeutics Granted Additional Patent Protection for Endoxifen
August 28 2024 - 8:30AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”), today announced that the United States Patent and
Trademark Office (USPTO) has granted a new patent (U.S. Patent No.
12,071,391) directed to compositions comprising endoxifen (in free
base or salt forms) and an enteric material in which at least 90
percent of the endoxifen is (Z)-endoxifen. The patent also covers
methods of administering those compositions to patients. Atossa is
a clinical stage biopharmaceutical company developing innovative
medicines in areas of significant unmet medical need in oncology
with a focus on breast cancer.
“This fourth issued patent by the United States Patent and
Trademark Office expands Atossa’s protection to include
(Z)-endoxifen salt compositions and methods of using those,” said
Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive
Officer. “The broader protection provided by this new patent will
create long-term stockholder value as it further validates and
expands Atossa’s patent protection beyond our previously issued
composition of matter patents, including U.S. Patent No.
11,572,334.”
About (Z)-Endoxifen(Z)-endoxifen is the most
potent Selective Estrogen Receptor Modulator (SERM) for estrogen
receptor inhibition and also causes estrogen receptor degradation.
It has also been shown to have efficacy in the setting of patients
with tumor resistance to other hormonal treatments. In addition to
its potent anti-estrogen effects, (Z)-endoxifen has been shown to
target PKCβ1, a known oncogenic protein, at clinically attainable
blood concentrations. Finally, (Z)-endoxifen appears to deliver
similar or even greater bone agonistic effects while resulting in
little or no endometrial proliferative effects compared with
standard treatments, like tamoxifen.
Atossa is developing a proprietary oral formulation of
(Z)-endoxifen that does not require liver metabolism to achieve
therapeutic concentrations and is encapsulated to bypass the
stomach, as acidic conditions in the stomach convert a significant
proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s
(Z)-endoxifen has been shown to be well tolerated in Phase 1
studies and in a small Phase 2 study of women with breast cancer.
(Z)-endoxifen is currently being studied in four Phase 2 trials:
one in healthy women with measurable breast density, one in women
diagnosed with ductal carcinoma in situ, and two other studies
including the EVANGELINE study in women with ER+/HER2- breast
cancer. Atossa’s (Z)-endoxifen is protected by four issued U.S.
patents and numerous pending patent applications.
About Atossa TherapeuticsAtossa Therapeutics,
Inc. is a clinical-stage biopharmaceutical company developing
innovative medicines in areas of significant unmet medical need in
oncology with a focus on using (Z)-endoxifen to prevent and treat
breast cancer. For more information, please visit
www.atossatherapeutics.com.
ContactMichael ParksVP, Investor and Public
Relations484-356-7105michael.parks@atossainc.com
FORWARD LOOKING STATEMENTSThis press release
contains certain information that may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. We may identify these forward-looking
statements by the use of words such as “expect,” “potential,”
“continue,” “may,” “will,” “should,” “could,” “would,” “seek,”
“intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or
other comparable words. Forward-looking statements in this press
release are subject to risks and uncertainties that may cause
actual results, outcomes, or the timing of actual results or
outcomes, such as data related to the (Z)-endoxifen program and the
potential of (Z)-endoxifen as a breast cancer prevention and
treatment agent, and potential milestones and growth opportunities
for the Company, to differ materially from those projected or
anticipated, including risks and uncertainties associated with:
macroeconomic conditions and increasing geopolitical instability;
the expected timing of releasing data; any variation between
interim and final clinical results; actions and inactions by the
FDA and foreign regulatory bodies; the outcome or timing of
regulatory approvals needed by Atossa, including those needed to
continue our planned (Z)-endoxifen trials; our ability to satisfy
regulatory requirements; our ability to remain compliant with the
continued listing requirements of the Nasdaq Stock Market; our
ability to successfully develop and commercialize new therapeutics;
the success, costs and timing of our development activities,
including our ability to successfully initiate or complete our
clinical trials, including our (Z)-endoxifen trials; our
anticipated rate of patient enrollment; our ability to contract
with third-parties and their ability to perform adequately; our
estimates on the size and characteristics of our potential markets;
our ability to successfully defend litigation and other similar
complaints and to establish and maintain intellectual property
rights covering our products; whether we can successfully complete
our clinical trial of oral (Z)-endoxifen in women with mammographic
breast density and our trials of (Z)-endoxifen in women with breast
cancer, and whether the studies will meet their objectives; our
expectations as to future financial performance, expense levels and
capital sources, including our ability to raise capital; our
ability to attract and retain key personnel; our anticipated
working capital needs and expectations around the sufficiency of
our cash reserves; and other risks and uncertainties detailed from
time to time in Atossa’s filings with the Securities and Exchange
Commission, including without limitation its Annual Reports on Form
10-K and Quarterly Reports on 10-Q. Forward-looking statements are
presented as of the date of this press release. Except as required
by law, we do not intend to update any forward-looking statements,
whether as a result of new information, future events or
circumstances or otherwise.
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