Atossa Therapeutics Selects PSI as Contract Research Organization for Pivotal Dose-Ranging Study of (Z)-Endoxifen in Metastatic Breast Cancer
Atossa Therapeutics (NASDAQ: ATOS) has selected PSI as its Contract Research Organization (CRO) for a pivotal Phase 2 dose-ranging study of (Z)-endoxifen in metastatic breast cancer. The study, designed with FDA guidance, will evaluate the drug's safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity.
The company plans to file an Investigational New Drug (IND) application in Q4 2025, with patient enrollment following thereafter and topline data expected in 2026. The study aims to inform a subsequent Phase 3 trial. The market opportunity includes approximately 170,000 women living with metastatic breast cancer in the United States.
PSI, selected for its expertise in oncology trials, achieved a 93% on-time or ahead-of-schedule enrollment rate in 2024. Atossa is also advancing additional Phase 2 studies of (Z)-endoxifen in various breast cancer settings, with multiple clinical readouts expected in the coming months.
Atossa Therapeutics (NASDAQ: ATOS) ha selezionato PSI come Contract Research Organization (CRO) per uno studio pivotale di Fase 2 con dosi variabili di (Z)-endoxifen nel carcinoma mammario metastatico. Lo studio, sviluppato seguendo le indicazioni della FDA, valuterà la sicurezza del farmaco, la farmacocinetica/farmacodinamica e i primi segnali di attività antitumorale.
L'azienda prevede di presentare un IND (Investigational New Drug) nel IV trimestre 2025, con successiva arruolamento dei pazienti e dati topline attesi nel 2026. Lo studio mira a fornire elementi utili per un successivo trial di Fase 3. Il mercato potenziale comprende circa 170.000 donne con carcinoma mammario metastatico negli Stati Uniti.
PSI è stata scelta per la sua esperienza negli studi oncologici e nel 2024 ha registrato un tasso di arruolamento del 93% in tempo o in anticipo rispetto ai programmi. Atossa sta inoltre portando avanti ulteriori studi di Fase 2 su (Z)-endoxifen in diversi contesti di carcinoma mammario, con molteplici letture cliniche previste nei prossimi mesi.
Atossa Therapeutics (NASDAQ: ATOS) ha seleccionado a PSI como su Contract Research Organization (CRO) para un estudio pivotal de Fase 2 de dosificación de (Z)-endoxifen en cáncer de mama metastásico. El estudio, diseñado con la orientación de la FDA, evaluará la seguridad del fármaco, su farmacocinética/farmacodinámica y la actividad antitumoral preliminar.
La compañía planea presentar un IND (Investigational New Drug) en el 4T de 2025, con posterior inicio del reclutamiento de pacientes y datos topline esperados en 2026. El estudio tiene como objetivo aportar información para un posterior ensayo de Fase 3. La oportunidad de mercado incluye aproximadamente 170.000 mujeres con cáncer de mama metastásico en Estados Unidos.
PSI fue seleccionada por su experiencia en ensayos oncológicos y alcanzó un índice de reclutamiento del 93% a tiempo o antes de lo previsto en 2024. Atossa también está avanzando otros estudios de Fase 2 de (Z)-endoxifen en distintos escenarios del cáncer de mama, con múltiples resultados clínicos esperados en los próximos meses.
Atossa Therapeutics (NASDAQ: ATOS)는 전이성 유방암에서 (Z)-엔독시펜의 용량 탐색을 위한 중대한 2상 시험의 수탁시험기관(CRO)으로 PSI를 선정했습니다. 해당 시험은 FDA 지침에 따라 설계되었으며 약물의 안전성, 약동학/약력학 및 초기 항종양 활성을 평가합니다.
회사는 2025년 4분기에 IND(임상시험 승인) 신청을 계획하고 있으며 이후 환자 등록을 진행하고 2026년에 톱라인 데이터 도출 예정입니다. 이 연구는 이후 3상 시험 설계에 관한 근거를 제공하는 것을 목표로 합니다. 미국 내 전이성 유방암으로 생활 중인 여성은 약 17만 명으로 추산됩니다.
PSI는 암 임상시험 경험을 인정받아 선정되었으며 2024년에 등록을 93% 정시 또는 계획보다 앞서 완료하는 성과를 냈습니다. Atossa는 또한 (Z)-엔독시펜의 추가 2상 연구들을 다양한 유방암 상황에서 진행 중이며, 향후 몇 달 내 여러 임상 결과가 발표될 예정입니다.
Atossa Therapeutics (NASDAQ: ATOS) a choisi PSI comme Contract Research Organization (CRO) pour une étude pivot de Phase 2 à plusieurs doses de (Z)-endoxifen dans le cancer du sein métastatique. L'étude, conçue avec les recommandations de la FDA, évaluera la sécurité du médicament, sa pharmacocinétique/pharmacodynamie et son activité antitumorale préliminaire.
La société prévoit de déposer un IND (Investigational New Drug) au T4 2025, puis de commencer le recrutement des patients, avec des données topline attendues en 2026. L'étude vise à fournir des éléments pour un essai de Phase 3 ultérieur. Le marché potentiel inclut environ 170 000 femmes vivant avec un cancer du sein métastatique aux États‑Unis.
PSI, retenue pour son expertise en essais oncologiques, a atteint un taux d'inclusion de 93 % à l'heure ou en avance en 2024. Atossa mène par ailleurs d'autres études de Phase 2 sur le (Z)-endoxifen dans différents contextes du cancer du sein, avec plusieurs résultats cliniques attendus dans les mois à venir.
Atossa Therapeutics (NASDAQ: ATOS) hat PSI als Contract Research Organization (CRO) für eine maßgebliche Phase‑2‑Dosisfindungsstudie mit (Z)-Endoxifen bei metastasiertem Brustkrebs ausgewählt. Die Studie wurde unter Berücksichtigung der FDA‑Leitlinien entworfen und wird Sicherheit, Pharmakokinetik/Pharmakodynamik sowie erste antitumorale Wirkungen prüfen.
Das Unternehmen plant, im 4. Quartal 2025 einen IND-Antrag einzureichen, anschließend Patienten zu rekrutieren und Topline‑Daten für 2026 zu erwarten. Ziel der Studie ist es, Daten für eine anschließende Phase‑3‑Studie zu liefern. Der Markt umfasst in den USA schätzungsweise etwa 170.000 Frauen mit metastasiertem Brustkrebs.
PSI wurde wegen seiner Expertise in onkologischen Studien ausgewählt und erzielte 2024 eine Einschlussquote von 93 % termingerecht oder früher. Atossa treibt zudem weitere Phase‑2‑Studien zu (Z)-Endoxifen in verschiedenen Brustkrebs‑Settings voran; mehrere klinische Auswertungen werden in den kommenden Monaten erwartet.
- Partnership with PSI, a CRO with 93% on-time enrollment rate in clinical trials
- Potential to address a large market of 170,000 metastatic breast cancer patients in the US
- (Z)-endoxifen shows activity in tumors resistant to existing therapies
- Multiple Phase 2 studies advancing in parallel with readouts expected soon
- IND filing and trial initiation still pending for Q4 2025
- Topline results not expected until 2026
- Success in Phase 2 required before advancing to Phase 3 trials
Insights
Atossa advances (Z)-endoxifen to pivotal Phase 2 study in metastatic breast cancer with FDA guidance, positioning for Phase 3 development.
Atossa's selection of PSI as their CRO for the dose-ranging study of (Z)-endoxifen represents a significant advancement in their clinical development program. This FDA-guided Phase 2 study is strategically designed to transition directly into Phase 3 trials, with an IND filing expected in Q4 2025 and topline results anticipated in 2026.
The clinical positioning of (Z)-endoxifen is particularly noteworthy. Unlike existing endocrine therapies, the compound has demonstrated activity against tumors that have developed resistance to current standard treatments like aromatase inhibitors and fulvestrant. This differentiation is crucial in metastatic breast cancer, where treatment resistance remains a major challenge.
From a market perspective, Atossa is targeting a substantial unmet need. Approximately
The selection of PSI appears strategic, with their
Beyond this metastatic breast cancer program, Atossa is advancing multiple Phase 2 studies of (Z)-endoxifen in early-stage settings, including monotherapy, combination therapy with abemaciclib, and treatment for DCIS. This pipeline diversity provides multiple potential paths to market.
Monotherapy Phase 2 study designed with FDA input; IND expected in Q4 2025
Topline results anticipated in 2026
Positions Atossa for transition into registrational Phase 3 development
The global Phase 2, multi-center dose-ranging study is designed to evaluate (Z)-endoxifen monotherapy for safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity. Patient enrollment is expected to follow the Investigational New Drug (IND) filing in Q4 2025, with topline data anticipated in 2026.
"This is a defining milestone for Atossa," said Dr. Steven Quay, Chairman and Chief Executive Officer of Atossa. "With PSI as our partner, we are advancing (Z)-endoxifen into its final steps before Phase 3. Unlike existing endocrine therapies, (Z)-endoxifen has demonstrated clinical activity even in tumors resistant to aromatase inhibitors and fulvestrant. If successful, this program could reshape the standard of care in breast cancer treatment, including in the metastatic setting, and deliver hope to patients who currently face limited options."
PSI is widely recognized for excellence in global oncology trial execution with the ability to move swiftly from Phase 2 into Phase 3 trials. In 2024, 93 percent of PSI-managed studies enrolled on time or ahead of schedule, leveraging its proprietary machine-learning feasibility platform, VISIONAL™. Atossa selected PSI, following a highly competitive process, for its proven ability to:
- Deliver regulatory-grade data through rigorous quality and compliance systems.
- Consistently achieve on-time enrollment across diverse geographies.
- Seamlessly scale programs into Phase 3 and pivotal studies, often reducing operational risk and accelerating timelines.
"We are excited to partner with Atossa on this pivotal study of (Z)-endoxifen. Based on our assessment, the program is designed to transition seamlessly into Phase 3, and we are allocating significant global resources to accelerate its execution. We believe this is a high-priority program with the potential to reshape the standard of care in metastatic breast cancer." — said Nick Sinackevich, PSI's President.
Market Opportunity
Each year, approximately 5.6 percent of newly diagnosed invasive breast cancers in women in the
Pipeline Momentum
In addition to the upcoming metastatic dose-ranging trial, Atossa is advancing additional Phase 2 studies in the ER+/HER2- neoadjuvant breast cancer setting (i.e., before definitive surgery), including studies of monotherapy of (Z)-endoxifen in early stage breast cancer; combination therapy with abemaciclib in women with early stage breast cancer at high risk of recurrence; and monotherapy in women with a biopsy-proven diagnosis of ductal carcinoma in situ (DCIS). Multiple clinical readouts are anticipated in the coming months.
About (Z)-Endoxifen
(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator/ Degrader (SERM/D) with dual mechanisms of action:
- Estrogen receptor inhibition and degradation, including in tumors resistant to other endocrine therapies.
- Direct inhibition of protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels.
Preclinical and clinical studies suggest (Z)-endoxifen may deliver superior bone-protective effects relative to tamoxifen, while maintaining a favorable safety profile. Across more than 700 subjects dosed up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, underscoring its potential for broad dose exploration. Clinical studies with tamoxifen demonstrate an inverse correlation between endoxifen blood concentration and hot flash severity score following adjustment for age, BMI, and menopausal status, suggesting it may deliver a better tolerance profile.
Atossa's proprietary oral, enteric-coated formulation is designed to preserve the active (Z)-isomer and promote optimal bioavailability, overcoming limitations of prior formulations.
About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment and prevention through innovative science and patient-focused solutions. The Company's lead product candidate, (Z)-endoxifen, is being developed as a therapy across the breast cancer spectrum, including prevention and treatment settings. For more information, please visit www.atossatherapeutics.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," "design," "predict," "future," or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding the Company's development strategy and related milestones, data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, including the potential IND submission, Phase 3 trial and related timing, the expected timing of releasing data; benefits of the Company's strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, the Company's progress across its pipeline, the strength of the Company's patent portfolio and expectations regarding related litigation, and the potential market and growth opportunities for the Company, are forward-looking statements. 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, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; any variation between interim or preliminary and final clinical results or analysis; 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 regain compliance or maintain compliance 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-selects-psi-as-contract-research-organization-for-pivotal-dose-ranging-study-of-z-endoxifen-in-metastatic-breast-cancer-302534234.html
SOURCE Atossa Therapeutics Inc
FAQ
When will Atossa Therapeutics (ATOS) begin its Phase 2 trial for (Z)-endoxifen?
What is the market size for Atossa's (ATOS) metastatic breast cancer treatment?
Why did Atossa Therapeutics choose PSI as their Contract Research Organization?
What other clinical trials is Atossa Therapeutics (ATOS) conducting for (Z)-endoxifen?
How does Atossa's (Z)-endoxifen differ from existing breast cancer treatments?
