Atossa Therapeutics, Inc. announced that it has reached full enrollment in the Company?s Karisma-Endoxifen clinical trial, the 240-person Phase 2 study investigating (Z)-endoxifen in premenopausal women with measurable mammographic breast density (MBD). Participants have been randomized to placebo, 1 mg, and 2 mg daily doses of (Z)-endoxifen and will be treated for six months, over the course of which mammograms are conducted to measure reduction in MBD. MBD change is used as a proxy for therapy response.

Between 40% and 50% of all women are estimated to have mammographically dense breasts, which makes mammography less sensitive and mammograms more difficult to interpret, since cancer and dense breast tissue both appear white on a mammogram. In women with the highest density, approximately 50% of all breast cancers are missed on a mammogram and diagnosed in the interval between two screening rounds. Because of this, interval cancers are often larger, more advanced, and more difficult to treat.

Women with the highest density are also four to six times more likely to develop breast cancer in their lifetime compared to women with the least dense breasts.