Atossa Therapeutics, Inc. announced that the (Z)-endoxifen arm of the ongoing Phase 2 I-SPY 2 clinical trial has fully enrolled. In the study, (Z)-endoxIFen, Atossa's proprietary Selective Estrogen Receptor Modulator (SERM), is being evaluated as a neoadjuvant treatment for newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer. This would transform the treatment paradigm for the hundreds of thousands of women diagnosed with ER-positive breast cancer every year.

The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. The (Z)-endoxifEN treatment arm, which enrolled 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP). Patients receive 10 mg of (Z)-endoxifan daily for up to 24 weeks prior to surgery.

About (Z)-endoxifin (Z)-endoxif En En En En Enrollment of (Z)-endox Ifen is the most active metabolite of the FDA approved Selective Estrogen Re receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifens. Atossa's (Z)-endoxifening is protected by three issued U.S. patents and numerous pending patent applications.