Atossa Therapeutics Partners with PSI for Crucial Trial of (Z)-Endoxifen in Advanced Breast Cancer
Atossa Therapeutics, Inc., a biopharmaceutical company focused on innovative breast cancer treatments, has made significant strides in its clinical development by choosing PSI as its contract research organization (CRO) for an upcoming pivotal dose-ranging study of (Z)-endoxifen in women with metastatic breast cancer (mBC). This decision is seen as a pivotal step in the development process of (Z)-endoxifen, particularly given the FDA's guidance that has shaped the design of the study.
Scheduled to take place as a global Phase 2, multi-center trial, the study aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of (Z)-endoxifen monotherapy. The enrollment of patients is expected to kick off following the submission of an Investigational New Drug (IND) application in Q4 2025, with results anticipated in 2026. Dr. Steven Quay, Chairman and CEO of Atossa, highlighted the significance of this collaboration: 'With PSI as our partner, we are advancing (Z)-endoxifen into its final steps before Phase 3.'
Atossa's approach is different from existing endocrine therapies, as (Z)-endoxifen has shown clinical effectiveness even against tumors that are resistant to traditional treatments like aromatase inhibitors and fulvestrant. This is crucial as resistance to current therapies often leaves patients with limited options, making a successful program like (Z)-endoxifen even more essential. If clinical trials demonstrate its efficacy, (Z)-endoxifen could have a transformative impact on breast cancer treatment strategies, especially for patients dealing with advanced stages of the disease.
PSI is known for its experience and expertise in oncology trials, successfully executing various studies and achieving timely patient enrollment across diverse locales. In 2024, PSI reported that 93% of the studies they managed met or exceeded enrollment timelines, aided by their utilization of a machine-learning feasibility platform called VISIONAL™. These capabilities aligned with Atossa's quality and compliance standards were major factors in selecting PSI amidst stiff competition.
The market implications for (Z)-endoxifen are substantial. In the U.S., around 5.6% of newly diagnosed invasive breast cancers are metastatic at the point of diagnosis, equating to approximately 13,000 cases annually. With an estimated 170,000 women living with metastatic breast cancer in the country, the need for effective therapies has never been more pressing. Atossa aims for (Z)-endoxifen to establish itself as a first-in-class option within this multi-billion dollar market.
In addition to the upcoming pivotal dose-ranging trial for metastatic breast cancer, Atossa is pursuing further Phase 2 studies targeting various aspects of breast cancer treatment. These include evaluating (Z)-endoxifen as a monotherapy in early-stage disease and in combination therapies that feature an established cancer medication, abemaciclib. As such trials progress, Atossa anticipates multiple clinical readouts that could shape the way breast cancer is treated moving forward.
(Z)-endoxifen is identified as a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D). Through dual mechanisms affecting estrogen receptor activity, it showcases promise even in tumors that resist other treatments. Furthermore, by directly targeting oncogenic proteins like protein kinase C beta 1 (PKCβ1) at clinically relevant levels, (Z)-endoxifen may offer superior bone-protective effects compared to existing therapies, while also enjoying a favorable safety profile. Its formulation is designed to maximize bioavailability, addressing shortcomings associated with previous treatments.
About Atossa Therapeutics, Inc.: Atossa is firmly committed to innovating breast cancer treatments and prevention strategies through dedicated research and patient-first solutions. (Z)-endoxifen remains a cornerstone of their strategy as they work to redefine standards in breast cancer care. For ongoing updates and information, please visit Atossa's official website.
Scheduled to take place as a global Phase 2, multi-center trial, the study aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of (Z)-endoxifen monotherapy. The enrollment of patients is expected to kick off following the submission of an Investigational New Drug (IND) application in Q4 2025, with results anticipated in 2026. Dr. Steven Quay, Chairman and CEO of Atossa, highlighted the significance of this collaboration: 'With PSI as our partner, we are advancing (Z)-endoxifen into its final steps before Phase 3.'
Atossa's approach is different from existing endocrine therapies, as (Z)-endoxifen has shown clinical effectiveness even against tumors that are resistant to traditional treatments like aromatase inhibitors and fulvestrant. This is crucial as resistance to current therapies often leaves patients with limited options, making a successful program like (Z)-endoxifen even more essential. If clinical trials demonstrate its efficacy, (Z)-endoxifen could have a transformative impact on breast cancer treatment strategies, especially for patients dealing with advanced stages of the disease.
PSI is known for its experience and expertise in oncology trials, successfully executing various studies and achieving timely patient enrollment across diverse locales. In 2024, PSI reported that 93% of the studies they managed met or exceeded enrollment timelines, aided by their utilization of a machine-learning feasibility platform called VISIONAL™. These capabilities aligned with Atossa's quality and compliance standards were major factors in selecting PSI amidst stiff competition.
The market implications for (Z)-endoxifen are substantial. In the U.S., around 5.6% of newly diagnosed invasive breast cancers are metastatic at the point of diagnosis, equating to approximately 13,000 cases annually. With an estimated 170,000 women living with metastatic breast cancer in the country, the need for effective therapies has never been more pressing. Atossa aims for (Z)-endoxifen to establish itself as a first-in-class option within this multi-billion dollar market.
In addition to the upcoming pivotal dose-ranging trial for metastatic breast cancer, Atossa is pursuing further Phase 2 studies targeting various aspects of breast cancer treatment. These include evaluating (Z)-endoxifen as a monotherapy in early-stage disease and in combination therapies that feature an established cancer medication, abemaciclib. As such trials progress, Atossa anticipates multiple clinical readouts that could shape the way breast cancer is treated moving forward.
(Z)-endoxifen is identified as a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D). Through dual mechanisms affecting estrogen receptor activity, it showcases promise even in tumors that resist other treatments. Furthermore, by directly targeting oncogenic proteins like protein kinase C beta 1 (PKCβ1) at clinically relevant levels, (Z)-endoxifen may offer superior bone-protective effects compared to existing therapies, while also enjoying a favorable safety profile. Its formulation is designed to maximize bioavailability, addressing shortcomings associated with previous treatments.
About Atossa Therapeutics, Inc.: Atossa is firmly committed to innovating breast cancer treatments and prevention strategies through dedicated research and patient-first solutions. (Z)-endoxifen remains a cornerstone of their strategy as they work to redefine standards in breast cancer care. For ongoing updates and information, please visit Atossa's official website.
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