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Atossa Therapeutics Proposes Potentially Groundbreaking Study Aimed at Reducing Interval Breast Cancer in High-Risk Women at AACR 2025
SEATTLE, April 29, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"SEATTLE, April 29, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today outlined a framework for a pioneering Phase 3 clinical study titled SMART 2.0. The proposed trial would investigate the potential of oral (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition, to significantly reduce interval breast cancer in women identified as high-risk through advanced mammographic screening techniques. The proposed SMART 2.0 study was presented at the American Association for Cancer Research (AACR) Annual Meeting and represents a future research program and potential partnership opportunity to advance this critical initiative for women at high risk of breast cancer. Interval breast cancers, diagnosed between regular mammography screenings, are typically more aggressive and challenging to treat than screen-detected cancers. Mammographic density has been recognized as a critical, modifiable risk factor for breast cancer and can complicate early detection. Previous research indicates (Z)-endoxifen, like tamoxifen, effectively reduces breast density and potentially enhances mammogram sensitivity. However, the adverse effects associated with tamoxifen limit its widespread use. Atossa’s innovative approach utilizes low-dose (1mg) Z-endoxifen, which reduced mammographic density by nearly 20 percent at six months and systemic side effects that were not statistically different than placebo in the Phase 2 KARISMA trial - an important step toward lowering the risk of interval breast cancer. The proposed SMART 2.0 trial would randomize participants identified by leveraging an AI Risk model into treatment and placebo groups to evaluate the effectiveness of (Z)-endoxifen over two years. The primary endpoint would measure the relative reduction in interval breast cancer incidence and tolerability compared to placebo over a two-year period of time. \"The SMART 2.0 study proposal represents a significant step forward for the advancement of breast cancer prevention,\" said Steven C. Quay, CEO of Atossa Therapeutics. \"By targeting mammographic density with Z-endoxifen, we hope to establish a safer, more effective preventive therapy for women at high risk.\" The company...