Atossa Therapeutics Commemorates Breast Cancer Awareness Month, Highlighting the Need for Innovation Across the Breast Cancer Treatment Continuum
Atossa Therapeutics (Nasdaq: ATOS) is recognizing Breast Cancer Awareness Month this October, emphasizing the need for innovation in breast cancer treatment. The company highlights the importance of education, early detection, and research in combating this disease that affects approximately one in eight women.
Atossa, a clinical-stage biopharmaceutical company, is currently evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 clinical trials. The Karisma-Endoxifen study is investigating its potential to reduce mammographic breast density in premenopausal women, with data expected in Q4 2024.
The company is also supporting the SMART study, a phase 2 trial validating an AI-driven breast cancer risk assessment model. This model could potentially serve as the foundation for a future phase 3 trial of (Z)-endoxifen in breast cancer prevention.
Atossa's efforts align with the FDA's recent implementation of updated mammography rules, which now require healthcare providers to notify women of their breast density results, a known risk factor for breast cancer.
Atossa Therapeutics (Nasdaq: ATOS) sta riconoscendo il Mese della Consapevolezza sul Cancro al Seno questo ottobre, sottolineando la necessità di innovazione nel trattamento del cancro al seno. L'azienda evidenzia l'importanza dell'istruzione, della diagnosi precoce e della ricerca nella lotta contro questa malattia che colpisce circa una donna su otto.
Atossa, un'azienda biofarmaceutica in fase clinica, sta attualmente valutando il suo principale asset, (Z)-endoxifen, in più studi clinici di fase 2. Lo studio Karisma-Endoxifen sta indagando il suo potenziale per ridurre la densità mammografica nelle donne in premenopausa, con dati attesi nel quarto trimestre del 2024.
L'azienda sta anche supportando lo studio SMART, un trial di fase 2 che valida un modello di valutazione del rischio di cancro al seno guidato dall'IA. Questo modello potrebbe potenzialmente servire come base per un futuro trial di fase 3 di (Z)-endoxifen nella prevenzione del cancro al seno.
Gli sforzi di Atossa sono in linea con la recente attuazione da parte della FDA di regole aggiornate sulla mammografia, che ora richiedono ai fornitori di assistenza sanitaria di notificare alle donne i risultati della loro densità mammaria, un noto fattore di rischio per il cancro al seno.
Atossa Therapeutics (Nasdaq: ATOS) está reconociendo el Mes de Concientización sobre el Cáncer de Mama este octubre, enfatizando la necesidad de innovación en el tratamiento del cáncer de mama. La empresa destaca la importancia de la educación, la detección temprana y la investigación en la lucha contra esta enfermedad que afecta aproximadamente a una de cada ocho mujeres.
Atossa, una compañía biofarmacéutica en etapa clínica, está evaluando actualmente su activo principal, (Z)-endoxifeno, en múltiples ensayos clínicos de fase 2. El estudio Karisma-Endoxifeno está investigando su potencial para reducir la densidad mamográfica en mujeres premenopáusicas, con datos esperados en el cuarto trimestre de 2024.
La empresa también está apoyando el estudio SMART, un ensayo de fase 2 que valida un modelo de evaluación de riesgo de cáncer de mama impulsado por IA. Este modelo podría servir potencialmente como la base para un futuro ensayo de fase 3 de (Z)-endoxifeno en la prevención del cáncer de mama.
Los esfuerzos de Atossa se alinean con la reciente implementación por parte de la FDA de reglas actualizadas sobre mamografías, que ahora requieren que los proveedores de atención médica notifiquen a las mujeres los resultados de su densidad mamaria, un conocido factor de riesgo para el cáncer de mama.
아토사 테라퓨틱스 (Nasdaq: ATOS)는 이 10월 유방암 인식의 달을 맞아 유방암 치료의 혁신 필요성을 강조하고 있습니다. 이 회사는 약 8명 중 1명에게 영향을 미치는 이 질병과의 싸움에서 교육, 조기 발견 및 연구의 중요성을 강조하고 있습니다.
아토사는 임상 단계의 생명공학 회사로 현재 주요 자산인 (Z)-엔독시펜을 여러 2상 임상 시험에서 평가하고 있습니다. 카리즘-엔독시펜 연구는 폐경 전 여성의 유방 밀도를 줄이는 잠재력을 조사하고 있으며, 데이터는 2024년 4분기에 예상됩니다.
회사는 또한 인공지능 기반의 유방암 위험 평가 모델을 검증하는 2상 임상 시험인 SMART 연구를 지원하고 있습니다. 이 모델은 유방암 예방을 위한 (Z)-엔독시펜의 향후 3상 시험의 기초가 될 수 있습니다.
아토사의 노력은 최근 FDA의 업데이트된 유방촬영술 규칙 시행과 일치하며, 이 규칙은 이제 의료 제공자가 여성에게 유방 밀도 결과를 통지하도록 요구합니다. 유방 밀도는 유방암의 알려진 위험 요소입니다.
Atossa Therapeutics (Nasdaq: ATOS) reconnaît ce mois d'octobre le Mois de la Sensibilisation au Cancer du Sein, en mettant l'accent sur la nécessité d'innovation dans le traitement du cancer du sein. L'entreprise souligne l'importance de l'éducation, du dépistage précoce et de la recherche dans la lutte contre cette maladie qui touche environ une femme sur huit.
Atossa, une entreprise biopharmaceutique en phase clinique, évalue actuellement son principal actif, (Z)-endoxifène, dans plusieurs essais cliniques de phase 2. L'étude Karisma-Endoxifène examine son potentiel à réduire la densité mammaire sur la mammographie chez les femmes en préménopause, avec des données attendues pour le quatrième trimestre 2024.
L'entreprise soutient également l'étude SMART, un essai de phase 2 validant un modèle d'évaluation du risque de cancer du sein basé sur l'IA. Ce modèle pourrait potentiellement servir de base pour un futur essai de phase 3 de (Z)-endoxifène dans la prévention du cancer du sein.
Les efforts d'Atossa s'alignent sur la récente mise en œuvre par la FDA de règles de mammographie mises à jour, qui exigent désormais que les prestataires de soins de santé informent les femmes de leurs résultats de densité mammaire, un facteur de risque connu pour le cancer du sein.
Atossa Therapeutics (Nasdaq: ATOS) erkennt diesen Oktober den Brustkrebsmonats an und betont die Notwendigkeit von Innovationen in der Brustkrebsbehandlung. Das Unternehmen hebt die Bedeutung von Bildung, Früherkennung und Forschung im Kampf gegen diese Erkrankung hervor, die etwa jede achte Frau betrifft.
Atossa, ein biopharmazeutisches Unternehmen in der klinischen Phase, bewertet derzeit sein Hauptprodukt, (Z)-Endoxifen, in mehreren Phase-2-Studien. Die Karisma-Endoxifen-Studie untersucht das Potenzial zur Reduzierung der mammografischen Brustdichte bei prämenopausalen Frauen, mit Daten, die im vierten Quartal 2024 erwartet werden.
Das Unternehmen unterstützt auch die SMART-Studie, eine Phase-2-Studie zur Validierung eines KI-gesteuerten Risikobewertungsmodells für Brustkrebs. Dieses Modell könnte potenziell als Grundlage für eine zukünftige Phase-3-Studie von (Z)-Endoxifen zur Brustkrebsprävention dienen.
Die Bemühungen von Atossa stimmen mit den jüngsten Aktualisierungen der Mammographie-Vorschriften der FDA überein, die nun verlangen, dass Gesundheitsdienstleister Frauen über ihre Ergebnisse zur Brustdichte informieren, die ein bekannter Risikofaktor für Brustkrebs sind.
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SEATTLE, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), today announced its recognition and support of Breast Cancer Awareness Month this October; highlighting the importance of increasing awareness, advancing research, and driving progress toward innovative treatments for breast cancer. Approximately one in eight women will be diagnosed with breast cancer in their lifetime, so this annual campaign serves as a powerful reminder of the ongoing need for education, early detection, prevention, and access to effective treatment options. Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer.
This year’s Breast Cancer Awareness Month takes on added significance with the recent implementation of the U.S. Food and Drug Administration’s (FDA) updated rule under the Mammography Quality Standards Act (MQSA). The new rule, which became effective on September 10, 2024, requires healthcare providers to notify women of their breast density results following a mammogram. Dense breast tissue is a known risk factor for breast cancer, and women with this condition are encouraged to consult with their healthcare providers about additional screening options to ensure earlier detection.
“As we honor Breast Cancer Awareness Month, it’s essential to reflect on the importance of education and early detection in the fight against breast cancer,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “While significant progress has been made, continued research is critical to improve outcomes for the millions of women impacted by breast cancer every year. At Atossa, we are dedicated to advancing innovative treatments and increasing awareness of risk factors, such as dense breast tissue, that can contribute to missed diagnoses.”
Atossa is currently evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 clinical trials, including the Karisma-Endoxifen study, which is investigating the potential for (Z)-endoxifen to reduce mammographic breast density in premenopausal women with measurable density. Data from this trial is expected in the fourth quarter of 2024. Currently, there are no approved treatments available to reduce breast density, a condition that can obscure tumors during mammograms and increase the risk of undiagnosed cancer.
Atossa is also supporting the SMART (Stockholm MAmmography Risk stratified Trial) study, a recently announced phase 2 study designed to validate an innovative, artificial intelligence driven, breast cancer risk assessment model. The 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.
About (Z)-Endoxifen
(Z)-endoxifen is one of the most potent Selective Estrogen Receptor Modulators (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/tissue 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 five 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 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
Michael Parks, VP Investor and Public Relations
484-356-7105
michael.parks@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, such as data related to the (Z)-endoxifen program, 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.
FAQ
What is Atossa Therapeutics (ATOS) doing for Breast Cancer Awareness Month in October 2024?
What clinical trials is Atossa Therapeutics (ATOS) currently conducting for breast cancer treatment?
How is Atossa Therapeutics (ATOS) involved in the SMART study for breast cancer?
What recent FDA rule change is relevant to Atossa Therapeutics' (ATOS) breast cancer awareness efforts?
When does Atossa Therapeutics (ATOS) expect to release data from the Karisma-Endoxifen study?
