Atossa Therapeutics (ATOS) released positive topline data from the KARISMA-Endoxifen Phase 2 study of z-endoxifen in premenopausal women with mammographic breast density, or MBD. The study, which was conducted through the Karolinska Institute in Stockholm, Sweden, demonstrated that low doses of Z-endoxifen significantly reduced MBD and was generally well tolerated. Study Highlights include: The Atossa sponsored ATOS-016R prevention trial included healthy women, randomized to daily placebo and 1 and 2 mg of Z-endoxifen. There were 80 women in each study arm and the study lasted six months; Mammographic breast density decrease was used as a proxy for therapy response. Measurements at six months or early terminations were compared to baseline density; No important differences in age, BMI or other background factors between randomization arms were seen; The relative significant density change was -19.3% and -26.5% for the 1 and 2 mg arms, respectively, using the placebo arm as a reference. No significant difference was seen comparing the 1 and 2 mg arms; In a 2011 study, women with a breast density decrease of 10 percent or greater after taking tamoxifen for one year had a 62 percent reduction in breast cancer incidence after 5 years; No changes in hematological safety tests or vital signs were noted during the trial period.
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