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Atossa Genetics Announces Phase 2 Study Contract for Oral Endoxifen to Reduce Mammographic Breast Density in Women
SEATTLE, Dec. 19, 2019 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"SEATTLE, Dec. 19, 2019 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced that it has contracted with Stockholm South General Hospital in Sweden to conduct a Phase 2 study of Atossa’s proprietary oral Endoxifen to reduce mammographic breast density (MBD) in women. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. MBD is an emerging public health issue, as studies conducted by others have shown that MBD increases the risk of developing breast cancer and that reducing MBD can reduce the incidence of breast cancer.\n “Atossa’s primary strategic objective is to develop oral Endoxifen to reduce MBD and this Phase 2 study is a major milestone in advancing this objective,” commented Steve Quay, M.D., Ph.D., President and CEO of Atossa. “Dr. Hall and his clinic are uniquely qualified to lead this study as they recently successfully completed the Phase 2 study of our topical Endoxifen, which demonstrated MBD reduction and they have conducted numerous studies using tamoxifen in both the treatment and prevention setting.” The primary endpoint of the new Phase 2 study is to determine whether oral Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of treatment. The secondary endpoints are safety and tolerability. Assuming the institutional review board (IRB) approves the study, enrollment is expected to open in the first quarter of 2020. Significant progress has been made with Atossa’s lead Endoxifen program: Atossa has completed multiple Phase 1 clinical studies using both a topical and oral (capsule and modified-release tablet) formulations of Endoxifen, the results of which indicated that oral Endoxifen was safe and well tolerated.Atossa’s recently completed Phase 2 study of topical Endoxifen found that, despite study participants reporting skin rashes and irritation, a statistically significant reduction in MBD was achieved in women taking the higher dose form of topical Endoxifen in as little as three months of dosing.In an FDA-approved, single patient, expanded access (or “compassionate use”) study, a b...