Atossa Therapeutics Announces Support of Clinical Study Testing New, Artificial Intelligence, Breast Cancer Risk Assessment Model
Atossa Therapeutics has announced its support for a Phase 2 study aiming to validate an AI-driven breast cancer risk assessment model. The Stockholm Mammography Risk stratified Trial (SMART) will enroll 70,000 women post-mammogram to assess their risk of developing breast cancer over the next two years. The Profound AI Model will analyze mammogram data and other personal risk factors to identify high-risk individuals. Those at highest risk will undergo a contrast-enhanced mammogram (CEM). The study aims to determine the predictive power of the AI model, potentially paving the way for a Phase 3 trial focusing on (Z)-endoxifen for breast cancer prevention.
- Support for Phase 2 study on AI-driven breast cancer risk model.
- SMART study will enroll 70,000 women, enhancing data reliability.
- Profound AI Model uses comprehensive data for risk assessment.
- Potential to identify high-risk women more accurately than current methods.
- Possibility of a Phase 3 trial if model is validated.
- Financial dependency on successful validation of AI model.
- High costs associated with large-scale clinical trials.
- Risk of AI model not being significantly more effective than current methods.
Insights
The support from Atossa Therapeutics for the SMART study is notable as it's testing an innovative AI-driven breast cancer risk assessment model. This model aims to more accurately predict breast cancer risk by analyzing mammographic features combined with personal risk factors. The current widely used model, the Gail Model, lacks such individualized approaches, making this a potentially significant advancement in breast cancer screening.
If validated, the Profound AI Model could transform breast cancer prevention by enabling more personalized interventions. However, the success of this initiative hinges on the model’s ability to outperform existing risk assessment tools.
For retail investors, the short-term impact may be limited as this is a Phase 2 study with results expected further down the line. However, successful validation could lead to a Phase 3 trial and eventual commercial application, potentially increasing Atossa's market valuation significantly. Investors should monitor the trial's progress and interim results for any indications of the model's effectiveness.
From a financial standpoint, Atossa's support for this study represents a strategic investment in the future of breast cancer prevention. Clinical trials and validation of innovative medical technologies often lead to significant financial returns if successful. Atossa's involvement could also bring credibility and attention to their pipeline, which may attract further investment and partnerships.
The scope of the study, involving 70,000 women, underscores the ambitious nature of this initiative. Investors should be prepared for a prolonged timeline before seeing any substantial financial returns. The costs associated with such large-scale trials can be substantial, but the potential benefits in terms of successful commercialization and enhanced company reputation in the medical field might justify these expenditures.
The application of artificial intelligence in healthcare is advancing rapidly and Atossa’s support of the Profound AI Model exemplifies this trend. The model's development involved training algorithms on imaging data to identify subtle patterns and risk factors not currently considered by standard tools. If successful, this approach could revolutionize breast cancer screening by providing more accurate risk assessments, leading to earlier and more precise interventions.
For investors, this signifies Atossa's commitment to cutting-edge technology, which could differentiate them in the competitive biotech sector. As the model undergoes clinical validation, its performance in real-world settings will be critical. Investors should look for updates on the model’s predictive accuracy and any early success stories from the trial to gauge its potential impact on the market.
SEATTLE, May 28, 2024 (GLOBE NEWSWIRE) -- 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
“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 Therapeutics
Atossa 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 Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTS
This 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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