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Atossa Therapeutics Receives Approval from Health Canada to Conduct Phase 2 EVANGELINE Clinical Trial in Canada
SEATTLE, July 20, 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, July 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that Health Canada has issued a “No Objection Letter” following the Company’s Clinical Trial Application for its Phase 2 EVANGELINE study. This means Atossa can open sites and enroll patients in their Phase 2 EVANGELINE study throughout Canada. The ongoing Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study 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 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. The study is expected to enroll approximately 175 patients at sites across the United States and Canada. \"The authorization of our Clinical Trial Application in Canada will increase the geographic scope of our enrollment efforts for EVANGELINE and broaden the network of breast cancer specialists familiar with (Z)-endoxifen in the neoadjuvant setting,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. \"In the coming weeks, we will have data from the pharmacokinetic run-in cohort, which is designed to identify the optimal dose for the treatment arm. Once the dose is confirmed, we expect the pace of enrollment to increase as we activate additional sites in the United Sates and Canada.” 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 cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtyp...