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Atossa Therapeutics Announces Positive Interim Phase 2 Data from Endoxifen Breast Cancer Treatment
SEATTLE, May 07, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"SEATTLE, May 07, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced positive interim results from its Phase 2 study of oral Endoxifen to treat breast cancer in the window of opportunity between diagnosis of breast cancer and surgery. A statistically significant (p = 0.031) reduction of about 74% in tumor cell proliferation was achieved over the 22 days of dosing. Proliferation was measured by Ki-67, a recognized standard measurement of breast cancer cell proliferation.\n Window of Opportunity Phase 2 Study Interim Results The purpose of this study is to determine if Atossa’s oral Endoxifen reduces breast cancer tumor cell proliferation as measured by several biomarkers, including Ki-67. The open-label study was designed to permit an interim analysis of the Ki-67 change. The requirement was to achieve a meaningful Ki-67 change in at least two of eight patients. All patients (N=6) experienced a significant reduction in Ki-67. A summary of these results includes: Ki-67 was reduced by more than 50% in every patient in the window of opportunity between initial biopsy and surgery, with an overall reduction of 74%.All six patients had a Ki-67 below 25% after treatment. In a paper entitled, “Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients,” Ki-67 was an independent prognostic value for predicting overall survival in ER+ breast cancer patients. Ki-67 levels below 25% were associated with the lowest risk of death in this systematic review and meta-analysis. Treatment ranged from 16-40 days with an average of 22 days.There were no safety or tolerability issues, including vasomotor symptoms such as hot flashes and night sweats, which are often a tolerability challenge for patients on tamoxifen. “These are the most significant and exciting results achieved in any of our Endoxifen clinical studies to date,” commented Steven C. Quay, Ph.D., M.D., Atossa’s CEO and President. “In designing the study, we had hoped that we could reduce tumor cell proliferation in at least two out of the first eight patients. The results surpassed our expectations wit...