Atossa Therapeutics Announces Support of Final Rule from FDA Requiring Patient Notification of Breast Density, a Critical Step in Addressing a Known Risk Factor for Breast Cancer
Atossa Therapeutics (Nasdaq: ATOS) supports the FDA's final rule update to mammography regulations, effective Sept. 10, 2024. The rule requires mammography facilities to provide patients with a breast density assessment in patient-friendly terms. This is important as breast density is a known risk factor for breast cancer and can obscure tumor detection. The regulation aims to improve early breast cancer detection by empowering women with dense breast tissue to discuss supplemental screening options with healthcare providers.
Atossa, focusing on breast cancer therapies, is evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 trials. The Karisma-Endoxifen study investigates its potential to reduce mammographic breast density in premenopausal women, with data expected by year-end 2024. Atossa also supports the SMART study, testing an AI-driven breast cancer risk assessment model, which could form the basis for a future phase 3 trial of (Z)-endoxifen in breast cancer prevention.
Atossa Therapeutics (Nasdaq: ATOS) sostiene l'aggiornamento finale della normativa sulla mammografia da parte della FDA, che entrerà in vigore il 10 settembre 2024. La norma prevede che le strutture di mammografia forniscano ai pazienti una valutazione della densità mammaria in termini comprensibili. Questo è importante poiché la densità mammaria è un noto fattore di rischio per il cancro al seno e può ostacolare la rilevazione dei tumori. La regolamentazione mira a migliorare la diagnosi precoce del cancro al seno dando potere alle donne con tessuto mammario denso di discutere le opzioni di screening supplementari con i fornitori di assistenza sanitaria.
Atossa, che si concentra sulle terapie per il cancro al seno, sta valutando il suo principale asset, (Z)-endoxifene, in diversi studi di fase 2. Lo studio Karisma-Endoxifene indaga il suo potenziale di ridurre la densità mammaria mammografica nelle donne in età premenopausale, con dati attesi entro la fine del 2024. Atossa supporta anche lo studio SMART, che testa un modello di valutazione del rischio di cancro al seno guidato dall'IA, che potrebbe costituire la base per un futuro studio di fase 3 su (Z)-endoxifene nella prevenzione del cancro al seno.
Atossa Therapeutics (Nasdaq: ATOS) apoya la actualización final de las normas de mamografía de la FDA, que entrará en vigor el 10 de septiembre de 2024. La norma requiere que las instalaciones de mamografía proporcionen a los pacientes una evaluación de la densidad mamaria en términos accesibles. Esto es importante ya que la densidad mamaria es un conocido factor de riesgo para el cáncer de mama y puede dificultar la detección de tumores. La regulación tiene como objetivo mejorar la detección temprana del cáncer de mama empoderando a las mujeres con tejido mamario denso para que discutan las opciones de detección suplementarias con los proveedores de atención médica.
Atossa, centrada en las terapias para el cáncer de mama, está evaluando su principal activo, (Z)-endoxifeno, en múltiples ensayos de fase 2. El estudio Karisma-Endoxifeno investiga su potencial para reducir la densidad mamográfica en mujeres premenopáusicas, con datos esperados para finales de 2024. Atossa también apoya el estudio SMART, que evalúa un modelo de evaluación de riesgo de cáncer de mama impulsado por IA, que podría formar la base para un futuro ensayo de fase 3 sobre (Z)-endoxifeno en la prevención del cáncer de mama.
Atossa Therapeutics (Nasdaq: ATOS)는 2024년 9월 10일부터 시행되는 FDA의 최종 규정 업데이트를 지원합니다. 이 규정은 유방 촬영시설이 환자에게 유방 밀도 평가를 이해하기 쉽게 제공해야 한다고 요구합니다. 유방 밀도는 유방암의 알려진 위험 요소이며 종양 탐지를 방해할 수 있기 때문에 중요합니다. 이 규정은 유방 밀도가 높은 여성들이 의료 제공자와 보조 검사 옵션에 대해 논의할 수 있도록 하여 유방암 조기 발견을 개선하는 것을 목표로 하고 있습니다.
유방암 치료에 집중하는 Atossa는 여러 개의 2상 시험에서 주요 자산인 (Z)-엔도이프렌을 평가하고 있습니다. Karisma-Endoxifen 연구는 생리 중인 여성의 유방 촬영 밀도를 줄이는 잠재력을 조사하며, 2024년 연말까지 데이터가 예상됩니다. Atossa는 또한 AI 기반의 유방암 위험 평가 모델을 테스트하는 SMART 연구를 지원하고 있으며, 이는 (Z)-endoxifen을 유방암 예방의 미래 3상 시험의 기초가 될 수 있습니다.
Atossa Therapeutics (Nasdaq: ATOS) soutient la mise à jour finale des règles de mammographie de la FDA, qui entrera en vigueur le 10 septembre 2024. Cette règle exige que les établissements de mammographie fournissent aux patients une évaluation de la densité mammaire dans des termes accessibles. Cela est important car la densité mammaire est un facteur de risque connu de cancer du sein et peut obscurcir la détection des tumeurs. La réglementation vise à améliorer la détection précoce du cancer du sein en permettant aux femmes ayant un tissu mammaire dense de discuter des options de dépistage supplémentaires avec les fournisseurs de soins de santé.
Atossa, axée sur les thérapies contre le cancer du sein, évalue son principal actif, (Z)-endoxifène, dans plusieurs essais de phase 2. L'étude Karisma-Endoxifène examine son potentiel à réduire la densité mammaire mammographique chez les femmes en pré-ménopause, avec des données attendues d'ici la fin de 2024. Atossa soutient également l'étude SMART, qui teste un modèle d'évaluation des risques de cancer du sein guidé par l'IA, qui pourrait constituer la base d'un futur essai de phase 3 sur (Z)-endoxifène dans la prévention du cancer du sein.
Atossa Therapeutics (Nasdaq: ATOS) unterstützt das endgültige Regelupdate der FDA zu Mammographie-Vorschriften, das am 10. September 2024 in Kraft tritt. Die Regel verlangt von Mammographie-Einrichtungen, dass sie den Patienten eine Bewertung der Brustdichte in verständlichen Begriffen zur Verfügung stellen. Dies ist wichtig, da die Brustdichte ein bekannter Risikofaktor für Brustkrebs ist und die Tumorerkennung behindern kann. Die Verordnung zielt darauf ab, die frühzeitige Erkennung von Brustkrebs zu verbessern, indem sie Frauen mit dichterem Brustgewebe in die Lage versetzt, zusätzliche Screening-Optionen mit den Gesundheitsdienstleistern zu besprechen.
Atossa, das sich auf Therapien gegen Brustkrebs konzentriert, bewertet ihr Hauptmittel, (Z)-Endoxifen, in mehreren Phase-2-Studien. Die Karisma-Endoxifen-Studie untersucht dessen Potenzial zur Verringerung der mammographischen Brustdichte bei prämenopausalen Frauen, wobei Daten bis Ende 2024 erwartet werden. Atossa unterstützt auch die SMART-Studie, die ein KI-gestütztes Modell zur Risikobewertung von Brustkrebs testet, das die Grundlage für eine zukünftige Phase-3-Studie von (Z)-Endoxifen zur Brustkrebsprävention bilden könnte.
- FDA's new rule aligns with Atossa's mission, potentially increasing demand for their breast cancer detection and prevention solutions
- Atossa's (Z)-endoxifen is in multiple phase 2 trials, including one for reducing mammographic breast density
- Data from the Karisma-Endoxifen study is expected by year-end 2024
- Atossa is supporting the SMART study, which could lead to a phase 3 trial for (Z)-endoxifen in breast cancer prevention
- Currently, there are no approved treatments to reduce breast density
- Results from ongoing clinical trials are still pending, creating uncertainty about the efficacy of Atossa's treatments
The FDA's final rule on breast density notification is a significant development in breast cancer screening. This mandate addresses a important gap in patient awareness, potentially leading to improved early detection rates. For Atossa Therapeutics, this regulatory change aligns perfectly with their ongoing research, particularly the Karisma-Endoxifen study.
The timing is opportune, as Atossa expects data from this trial by year-end 2024. If (Z)-endoxifen demonstrates efficacy in reducing mammographic breast density, it could position Atossa as a pioneer in this newly highlighted area of need. The lack of approved treatments for reducing breast density presents a substantial market opportunity.
Moreover, Atossa's involvement in the SMART study, using AI for risk assessment, shows foresight in combining regulatory changes with cutting-edge technology. This proactive approach could give Atossa a competitive edge in the evolving landscape of breast cancer prevention and early detection.
This regulatory update could have positive implications for Atossa Therapeutics' market position and potential revenue streams. The FDA's mandate creates a new market demand for solutions addressing breast density, aligning with Atossa's research focus.
Investors should note that while this news doesn't directly impact Atossa's financials, it enhances the company's strategic positioning. The potential success of (Z)-endoxifen in reducing breast density could lead to significant market opportunities, especially given the lack of approved treatments in this area.
However, it's important to remember that Atossa is still in the clinical stage, with no approved products. The company's
The FDA's final rule on breast density notification is a game-changer for breast cancer screening and risk assessment. As an oncologist, I can attest to the challenges dense breast tissue poses in mammography interpretation. This mandate will likely lead to increased demand for supplemental screening methods like ultrasound and MRI, potentially improving early detection rates.
Atossa's focus on (Z)-endoxifen for reducing mammographic breast density is particularly intriguing. If successful, it could offer a pharmacological solution to a problem that currently lacks approved treatments. This approach could revolutionize breast cancer prevention strategies, especially for high-risk patients.
The SMART study's AI-driven risk assessment model is another exciting development. If validated, it could significantly enhance our ability to identify high-risk individuals, potentially leading to more targeted and effective prevention strategies.
FDA Update to Mammography Regulations in MQSA Final Rule is Effective Today
SEATTLE, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), today announced its support of the U.S. Food and Drug Administration (FDA) for issuing a final rule to update the mammography regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which becomes effective today. Among the updates, the final rule requires mammography facilities to provide patients with an assessment of breast density in patient friendly terms. 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.
Implementation of the FDA’s final rule marks a significant step forward in the ongoing effort to improve breast cancer detection and patient outcomes. Breast density is a known, independent risk factor for developing breast cancer and can obscure the detection of tumors during mammography. This regulation is expected to significantly improve early breast cancer detection by ensuring that women with dense breast tissue are notified, empowering them to have informed discussions with their healthcare providers about supplemental screening options such as ultrasound or MRI, which may detect cancers that mammograms might miss.
“The implementation of the breast density notification rule is commendable and paves the way for better detection and diagnosis,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “The new requirements lay the groundwork for guiding patients and physicians in managing dense breast tissue, especially concerning Estrogen Receptor-positive (ER+) breast cancers, where density plays a critical role in risk assessment.”
Atossa recognizes the significance of this rule as it aligns with the Company's mission to advance the early detection and prevention of breast cancer. 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 the trial is expected prior to year-end 2024. Currently, there are no approved treatments to reduce breast density.
Atossa is also proudly 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 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/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 the new FDA rule regarding breast density that Atossa Therapeutics (ATOS) supports?
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