Atossa and Quantum Leap Collaborate on Breast Cancer Trial
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Atossa Therapeutics Partners with Quantum Leap for Clinical Trial
Atossa Therapeutics, Inc. (Nasdaq: ATOS) and Quantum Leap Healthcare Collaborative™ (QLHC) have announced the initiation of their clinical trial involving Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO), aimed at treating high-risk women diagnosed with Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
Details of the Clinical Trial
The trial is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), focusing on patients whose tumors are predicted to respond to endocrine therapy but may not benefit from chemotherapy. These patients often face a high risk of recurrence and require more effective and tolerable treatment options.
Study Design and Cohort
The combination study will enroll approximately 80 participants across two cohorts of 40 women each. Participants will receive 80 mg of (Z)-endoxifen daily along with 150 mg of abemaciclib twice daily for a duration of 24 weeks prior to surgery. Premenopausal women in the second cohort will also undergo ovarian function suppression (OFS) to evaluate its effects alongside the treatment.
Study Timeline and Expectations
The data from this trial, expected in 2026, aims to further substantiate the evidence surrounding the safety and efficacy of (Z)-endoxifen for both premenopausal and postmenopausal breast cancer patients.
Company Insights and Future Directions
Dr. Steven Quay, Atossa’s President and CEO, remarked on the milestone achievement of dosing the first patient, highlighting the potential of this innovative combination therapy to enhance treatment experiences for women with invasive breast cancer. The trial reflects Atossa's commitment to developing patient-friendly treatment solutions.
Expert Opinions on the Trial's Importance
Dr. Jo Chien, Professor of Medicine at UCSF, expressed excitement over the trial's commencement, emphasizing the necessity for improved treatment options for patients with HR+ tumors that exhibit high clinical risk.
About (Z)-Endoxifen
(Z)-endoxifen is recognized for its potent inhibitory effects on estrogen receptors and its role in degrading these receptors. This investigational drug presents efficacy for patients resistant to other hormonal therapies while maintaining a favorable safety profile compared to conventional treatments.
Atossa Therapeutics Overview
Atossa is dedicated to innovating in oncology and is particularly focused on utilizing (Z)-endoxifen for breast cancer prevention and treatment. For more information, please contact the company's public relations team.
Contact Information
Michael Parks, VP Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
Quantum Leap Healthcare Collaborative Media Contact:
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.
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