Business
Atossa Therapeutics, Inc. Receives Authorization from FDA to Initiate its Phase 2 Study of Neoadjuvant (Z)-endoxifen in Premenopausal Women with ER+/HER2- Breast Cancer
Atossa to begin Phase 2 Study of (Z)-endoxifen in 4th Quarter SEATTLE, Oct. 24, 2022 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"Atossa to begin Phase 2 Study of (Z)-endoxifen in 4th Quarter\nSEATTLE, Oct. 24, 2022 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer, announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and authorized initiation of its Phase 2 neoadjuvant clinical study of (Z)-endoxifen in premenopausal women with early-stage estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This is the first study of Atossa’s proprietary (Z)-endoxifen in the United States. At this time, Atossa also announced that it is discontinuing its COVID-19 program (AT-301) so that it can refocus resources on this critical study in breast cancer. “Continuing the development of our proprietary (Z)-endoxifen here in the United States has been a key goal which builds on the recent issuance of a U.S. patent for our proprietary (Z)-endoxifen and results from our Phase 2 “window-of-opportunity” study in Australia,” commented Steven Quay, M.D., Ph.D., Atossa’s CEO, Chairman and President. “We are excited to have engaged Dr. Matthew Goetz, the Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D. at Mayo Clinic and Director of the Mayo Clinic Breast Cancer SPORE, as the lead principal investigator for this multi-center study. We look forward to opening the study in the fourth quarter.” About the Study The study, “A Randomized Phase 2 Noninferiority Trial of (Z)-endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment in Premenopausal Women with ER+/HER2- Breast Cancer”, or also known as “EVANGELINE,” is an open-label, randomized, Phase 2 study designed to investigate (Z)-endoxifen for the neoadjuvant treatment of premenopausal women ages 18 and older with early stage (Grade 1 or 2) ER+/HER2- breast cancer. InClin Inc., a full-service Contract Research Organization, has been contracted to execute this study. This study is a multicenter (approximately 25 sites) study in United States and will enroll about 175 patients and is designed with two cohorts: a PK Run-In Cohort to investigate pharmacokinetics and identify a dose for the Treatment Cohort and a Treatm...