Business
Atossa Completes Enrollment of Pharmacokinetic Run-In Cohort in Phase 2 EVANGELINE Clinical Trial Evaluating (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer
SEATTLE, June 12, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"SEATTLE, June 12, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a focus on breast cancer, today announces that the pharmacokinetic (PK) run-in cohort of the Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study has fully enrolled. 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. The PK run-in cohort consists of six patients, all of whom will be treated with (Z)-endoxifen at 40mg/day for four weeks. The goal of the PK run-in cohort is to determine if the 40mg dose delivers steady-state plasma concentrations (Css) between 500 - 1000 ng/mL, which are optimal to target PKCβ1 inhibition and enhance (Z)-endoxifen’s antitumor mechanism of action. Once the optimal dose of (Z)-endoxifen is determined, the Treatment Cohort will commence. Participants in the treatment cohort 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. \"We are excited to fully enroll the EVANGELINE PK run-in cohort and look forward to seeing data in Q3 of this year,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “The data will show us if the 40mg dose delivers the steady-state plasma concentrations required to effectively target PKCβ1 inhibition and enhance (Z)-endoxifen’s antitumor mechanism of action, or if we need to further optimize the dose. Identifying the optimal dose is an important milestone as it will allow us to activate additional sites in the US and advance plans to open sites outside of the US, which will increase the speed of recruitment for the EVANGELINE treatment cohort.” About Premenopausal Women with ER+ / HER2- Breast CancerBreast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast canc...