Atossa Therapeutics doses first patient in Phase 2 EVANGELINE study

Atossa Therapeutics announces that the first patient has been dosed in the Phase 2 EVANGELINE study. EVANGELINE is a randomized non-inferiority trial of Atossa’s patented Selective Estrogen Receptor Modulator, (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. Participants will receive neoadjuvant treatment for up to six months, followed by surgery. The study is expected to enroll approximately 175 patients at up to 25 sites across the United States. The primary objective of the EVANGELINE study is to evaluate the endocrine sensitive disease rate, measured by Ki-67, after four weeks of treatment with (Z)-endoxifen compared to treatment with current standard of care, exemestane plus goserelin. "We are excited to kick-off this important trial, a significant achievement in our development strategy," said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. "Approximately 78% of breast cancers are ER+ / HER2- and premenopausal women diagnosed with this disease need more effective and tolerable treatment options; specifically new treatments that do not require ovarian function suppression. We feel (Z)-endoxifen has the potential to change the treatment paradigm for these patients."