Atossa Doses First Patient in Phase 2 Neoadjuvant Clinical Study of (Z)-Endoxifen in Premenopausal Women with ER+/HER2- Breast Cancer

About this update from Atossa Therapeutics, Inc.

[{"type":"text","content":"SEATTLE, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet need in cancer, today announces that the first patient has been dosed in the Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study. EVANGELINE is a randomized non-inferiority trial of Atossa’s patented Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, and exemestane plus goserelin as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. Participants will receive neoadjuvant treatment for up to six months, followed by surgery. The study is expected to enroll approximately 175 patients at up to 25 sites across the United States. The primary objective of the EVANGELINE study is to evaluate the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen compared to treatment with current standard of care, exemestane plus goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, also called ovarian function suppression (OFS). In premenopausal women, OFS is associated with significant morbidity and inadequate compliance, which compromises efficacy and increases the risk of mortality. (Z)-endoxifen is the most active anti-estrogen metabolite of tamoxifen that potently blocks ERa and binds to and disrupts protein kinase C beta one function (PKCb1, a known oncogenic protein). In an earlier Phase 2 study, treatment with (Z)-endoxifen resulted in a 65.1% reduction in Ki-67. This is potentially clinically meaningful because numerous studies by other groups have shown that reducing Ki-67 is prognostic for 5-year disease free survival. (Z)-endoxifen administered as monotherapy may also obviate the need for OFS in premenopausal women and potentially reduce breast cancer cell proliferation. “We are excited to kick-off this important trial, a significant achievement in our development strategy,” said Dr. Steven Quay, Atossa’s President and Chief Executive Of...

More updates from Atossa Therapeutics, Inc.