Atossa Therapeutics Announces Support of New Breast Cancer Screening Guidelines
2024年5月7日 - 9:30PM
Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”) today announced its support of new guidelines released
by the U.S. Preventive Services Task Force (USPSTF) recommending
that women begin breast cancer screening starting at age 40. 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.
The updated guidelines recommend women undergo biennial
mammography screening beginning at the age of 40 until the age of
74. The change to the recommended age comes in response to rising
breast cancer rates among younger women and racial disparities in
breast cancer diagnosis and mortality. The announced changes from
USPSTF also come in advance of a September 2024 deadline mandated
by U.S. FDA requiring mammogram facilities to provide women with
detailed information regarding their breast density, as part of
routine mammograms. Breast density is a significant independent
risk factor for the development of breast cancer and can also
decrease the effectiveness of mammograms in detecting cancerous
lesions. Atossa Therapeutics recognizes the significance of these
improved guidelines in empowering both healthcare providers and
patients to make informed decisions regarding breast cancer
screening and treatment.
Atossa is currently evaluating its lead asset, (Z)-endoxifen, in
five Phase 2 clinical trials. One of those trials, the
Karisma-Endoxifen study, is investigating (Z)-endoxifen’s ability
to reduce mammographic breast density in premenopausal women with
measurable density. The trial fully enrolled in November 2023 and
data is expected in the second half of 2024. Currently, there are
no approved treatments to reduce breast density.
“The new guidelines will undoubtedly improve timely access to
patient care and save lives by enabling earlier diagnosis and
treatment of breast cancer,” said Steven Quay, M.D., Ph.D.,
Atossa’s President and Chief Executive Officer. “However, a bigger
opportunity to help women is by developing therapies to prevent
breast cancer from ever occurring. Half the women in the world over
the age of 40 have dense breast tissue and women with very dense
breasts are five-times more likely to get breast cancer than women
with fatty breasts. Reducing breast density would not only make
mammograms more effective, but more importantly, it could
significantly reduce the likelihood that these women ever develop
breast cancer.”
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 three 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.
Contact:Eric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@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, including the timing of data related to the (Z)-endoxifen
program, the potential of (Z)-endoxifen as a breast cancer
prevention and treatment agent, and the potential safety and
tolerability profile of (Z)-endoxifen, 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 comply 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.
Atossa Therapeutics (NASDAQ:ATOS)
過去 株価チャート
から 5 2024 まで 6 2024
Atossa Therapeutics (NASDAQ:ATOS)
過去 株価チャート
から 6 2023 まで 6 2024