Atossa Therapeutics completes enrollment of 80mg PK run-in cohort

Atossa Therapeutics announced that the 12-patient 80mg pharmacokinetic, PK, run-in cohort of the Phase 2 EVANGELINE study has fully enrolled. EVANGELINE is a randomized non-inferiority trial of Atossa’s patented Selective Estrogen Receptor Modulator, SERM, (Z)-endoxifen, and exemestane plus goserelin as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive / Human Epidermal Growth Factor Receptor 2 negative breast cancer. 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 80mg PK run-in cohort consists of 12 pre-menopausal women, all of whom will be treated with (Z)-endoxifen at 80mg/day for four weeks. After four weeks of treatment, participants with Ki-67 levels below 10% will continue on study drug for five additional months, followed by surgery. Ki-67 is a cellular marker for proliferation that indicates how fast the tumor is growing. Once the optimal dose of (Z)-endoxifen is determined, the treatment cohort will commence. The study is expected to enroll approximately 175 patients at up to 25 sites across the United States.