Atossa Therapeutics Announces Support of Clinical Study Testing New, Artificial Intelligence, Breast Cancer Risk Assessment Model
May 28 2024 - 8:30AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”), today announced support for a new Phase 2 study
designed to validate an innovative, artificial intelligence driven,
breast cancer risk assessment model. The SMART (Stockholm
MAmmography Risk stratified Trial) study will test an
individualized, imaging-based screening model designed to identify
women with the highest risk of developing breast cancer in the next
two years. If the model is validated for therapeutic use, it could
serve as the foundation for a future, Phase 3, trial investigating
(Z)-endoxifen in the breast cancer prevention setting. 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.
A short 'explainer' video about the SMART study can be found
here: SMART Study Video Explainer.
The SMART study is expected to enroll 70,000 women who will join
following their regularly scheduled bi-annual mammogram, the cost
of which is covered by the nationalized healthcare system in
Sweden. Mammogram results and additional assessment data will be
analyzed by a proprietary algorithm known as the Profound
Artificial Intelligence (AI) Risk Assessment Model (“Profound AI
Model”), which will determine each participant’s risk of developing
breast cancer in the next two years. The approximately 20% of women
who have the highest risk of developing breast cancer in the next
two years will be randomized into two arms. In the intervention
arm, the approximately 7,000 women at highest risk will have a
contrast enhanced mammogram (CEM). CEM has proven to better
identify cancers that were missed on the regular mammogram because
of dense breast tissue. Participants in the control arm will screen
according to current guidelines, that is, return in two years for
their next regularly scheduled mammogram. The study will measure
how many women across both arms (the “high risk” population)
develop breast cancer over the next two years, which will determine
the predictive power of the proprietary algorithm.
“The SMART study will be the largest prospective clinical trial
in the history of medicine that is intended to test if
individualized, risk-based breast cancer screening is superior to
current practice,” said Dr. Per Hall, Professor of Epidemiology at
the Department of Medical Epidemiology and Biostatistics at
Karolinska Institutet, Stockholm, Sweden, and Principal
Investigator of the SMART clinical trial. “The breast cancer risk
models that are widely used today are simply not effective, in
large part because they fail to consider the individual woman. Our
model includes imaging and other patient specific risk factors,
which we think will allow us to predict, with a much higher degree
of certainty, the risk a woman faces of developing breast cancer in
the next two years.”
The Profound AI Model is based on an artificial intelligence
algorithm that was educated by imputing the “normal” baseline
mammograms from about 1,700 women who developed an interval breast
cancer and comparing that to approximately 9,000 women not
diagnosed with breast cancer. An interval cancer is one that is
diagnosed before or at the next two-year screening mammogram. The
algorithm was run to find the features on the two sets of
mammograms that were most different and to assign mathematical
factors to the collected features that made the algorithm most
predictive. The algorithm has been validated in diverse and
independent populations.
Microcalcifications, artificial intelligence generated
mammographic features, the asymmetry of the left and right breast,
and other factors rose to the top of importance by this process.
These are factors that are currently not included in the widely
used Breast Cancer Risk Assessment Tool (BCRAT), also known as The
Gail Model. This model, which estimate a woman's risk of developing
invasive breast cancer over the next five years and up to age 90
(lifetime risk), only considers a woman's personal medical and
reproductive history and the history of breast cancer among her
first-degree relatives. The Profound AI Model takes a much more
individualized approach by first considering mammography features
and then factoring in additional risk factors including body mass
index, whether the woman has taken hormone replacement therapy,
family history and alcohol and tobacco use.
"Atossa is proud to help sponsor this groundbreaking study,”
said Steven Quay, M.D., Ph.D., Atossa’s President and Chief
Executive Officer. "Validating the Profound AI Risk model for
therapeutic purposes will allow us to leverage the algorithm for
the planned SMART 2 study, which would run concurrently with the
SMART trial. In SMART 2, we would use the Profound AI Risk Model to
identify women at the highest risk of developing breast cancer in
the next two years and randomize them into two cohorts, a treatment
group who will be treated with daily (Z)-endoxifen and a control
group, who will take a placebo. We can then look at the number of
women who develop breast cancer over that two-year period and
determine if treatment with (Z)-endoxifen prevents 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.
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