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Atossa Therapeutics Announces Full Results from Phase 2 KARISMA-Endoxifen Study Demonstrating Statistically Significant Reductions in Mammographic Breast Density
Wednesday, 11th December at 8:15 am
1 MG Dose (Z)-Endoxifen Shows Potential as a Well-Tolerated, Preventative Therapy for Premenopausal Women at Risk of Developing Breast Cancer
Data to be Presented in a Poster Spotlight Session During the 2024 San Antonio Breast Cancer Symposium
SEATTLE, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ: ATOS) ("Atossa" or the "Company"), today announced full results from its Phase 2 KARISMA-Endoxifen trial conducted at the Karolinska Institute in Stockholm, Sweden. The data, which will be presented during a Poster Spotlight Session at the 2024 San Antonio Breast Cancer Symposium, highlight the potential of low-dose (Z)-endoxifen to significantly reduce mammographic breast density (MBD), a key risk factor for breast cancer, while demonstrating a favorable safety profile. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
The randomized, double-blind, placebo-controlled study enrolled 240 premenopausal women aged 40-55, randomized to one of three arms: placebo, 1 mg, or 2 mg of daily oral (Z)-endoxifen for six months. The study aimed to evaluate reductions in MBD and assess safety and tolerability.
Results showed that the 1 mg dose of (Z)-endoxifen reduced MBD by 17.3 percentage points (p<0.01), while the 2 mg dose achieved a reduction of 23.5 percentage points (p<0.01), compared to a minimal change in the placebo group of 0.27 percentage points. Plasma concentrations for (Z)-endoxifen were measured at 4.8 ng/mL and 9.7 ng/mL for the 1 mg and 2 mg arms, respectively, highlighting the effectiveness of the lower dose in achieving significant reductions.
Importantly, no significant differences in adverse events were observed between the 1 mg dose and placebo. The 2 mg dose was associated with higher rates of hot flashes, night sweats and vaginal discharge.
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