Atossa Therapeutics Teams Up with Quantum Leap for New Clinical Trial
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has partnered with Quantum Leap Healthcare Collaborative™ (QLHC) to launch a clinical trial that will explore the use of Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO). This trial is specifically aimed at high-risk women diagnosed with Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
Overview of the Clinical Trial
This trial is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which focuses on patients whose tumors are expected to respond to endocrine therapy but may not gain benefits from chemotherapy. These patients often face a significant risk of cancer recurrence and are in need of more effective and tolerable treatment alternatives.
Study Design and Participant Groups
The study plans to enroll around 80 participants, divided into two groups of 40 women each. Each participant will take 80 mg of (Z)-endoxifen daily, alongside 150 mg of abemaciclib twice daily, for a period of 24 weeks before undergoing surgery. Additionally, premenopausal women in the second group will receive ovarian function suppression (OFS) to assess its impact in conjunction with the treatment.
Timeline and Anticipated Results
The results from this trial are expected to be available in 2026, and they aim to provide further evidence regarding the safety and effectiveness of (Z)-endoxifen for both premenopausal and postmenopausal breast cancer patients.
Insights from the Company and Future Plans
Dr. Steven Quay, Atossa’s President and CEO, expressed his enthusiasm about the milestone of administering the first dose to a patient. He emphasized the promise of this innovative combination therapy to improve the treatment experience for women battling invasive breast cancer. This trial underscores Atossa's dedication to creating patient-friendly treatment options.
Expert Perspectives on the Trial's Significance
Dr. Jo Chien, a Professor of Medicine at UCSF, shared her excitement regarding the trial's launch, highlighting the urgent need for enhanced treatment options for patients with HR+ tumors that are at a high clinical risk.
Understanding (Z)-Endoxifen
(Z)-endoxifen is known for its strong inhibitory effects on estrogen receptors and its ability to degrade these receptors. This investigational drug shows promise for patients who are resistant to other hormonal therapies while maintaining a favorable safety profile compared to standard treatments.
About Atossa Therapeutics
Atossa is committed to advancing oncology and is particularly focused on leveraging (Z)-endoxifen for the prevention and treatment of breast cancer. For additional information, please reach out to the company's public relations team.
Contact Information
Michael Parks, VP Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
Media Contact at Quantum Leap Healthcare Collaborative:
Jacqueline Murray
Director, Marketing and Communications
(415) 839-8082
j.murray@quantumleaphealth.org
Frequently Asked Questions
What is the purpose of the clinical trial?
The clinical trial aims to evaluate the effectiveness of (Z)-endoxifen in combination with abemaciclib for treating high-risk ER+/HER2- breast cancer.
How many participants will be enrolled in the trial?
Approximately 80 participants will be enrolled across two cohorts.
What is (Z)-endoxifen?
(Z)-endoxifen is a selective estrogen receptor modulator with potential benefits for patients resistant to other treatments.
What are the expected outcomes of the trial?
The trial aims to validate the safety and efficacy of the combination therapy and improve treatment options for breast cancer patients.
Who is conducting the trial?
The trial is a collaboration between Atossa Therapeutics and Quantum Leap Healthcare Collaborative.
