Atossa Therapeutics Completes Enrollment of 80mg Pharmacokinetic Run-In Cohort in Phase 2 EVANGELINE Clinical Trial Evaluating (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer

Core Insights - Atossa Therapeutics has fully enrolled the 12-patient 80mg pharmacokinetic run-in cohort of the Phase 2 EVANGELINE study, which is a randomized non-inferiority trial comparing (Z)-endoxifen to exemestane plus goserelin for treating pre-menopausal women with ER+/HER2- breast cancer [1][5] Group 1: Study Details - The 80mg PK run-in cohort consists of 12 pre-menopausal women treated with (Z)-endoxifen at 80mg/day for four weeks, with further treatment based on Ki-67 levels [2] - The study aims to enroll approximately 175 patients across up to 25 sites in the U.S. [2] - The primary objective is to evaluate the endocrine sensitive disease rate, measured by Ki-67, after four weeks of treatment with (Z)-endoxifen compared to the standard care [5] Group 2: Efficacy and Safety - Data from the previous 40mg PK run-in cohort showed a 92% average reduction in Ki-67 and a 37% average decrease in target lesions after 24 weeks of treatment [3] - The 80mg dose is expected to enhance (Z)-endoxifen's antitumor efficacy by fully targeting PKCβ1 inhibition [3][4] Group 3: Drug Profile - (Z)-endoxifen is noted for its potent estrogen receptor inhibition and ability to degrade estrogen receptors, showing efficacy in patients resistant to other hormonal treatments [6] - The drug is designed to bypass liver metabolism and stomach acidity, ensuring therapeutic concentrations [7] - Atossa's (Z)-endoxifen is protected by three issued U.S. patents and is currently being studied in multiple Phase 2 trials [8]