Atossa, Quantum Leap announce new study arm to evaluate z-Endoxifen

Atossa Therapeutics and Quantum Leap Healthcare Collaborative announce that Atossa’s proprietary Selective Estrogen Receptor Modulator, SERM, (Z)-endoxifen, will be evaluated in a new study arm of the ongoing I-SPY 2 clinical trial. The I-SPY 2 TRIAL evaluates neoadjuvant treatments for locally advanced breast cancer and 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 new study arm evaluating (Z)-endoxifen is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol, which targets patients with newly diagnosed estrogen receptor-positive invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. Atossa is currently evaluating (Z)-endoxifen in two ongoing Phase 2 studies: The EVANGELINE trial is a randomized non-inferiority study of (Z)-endoxifen compared to exemestane plus goserelin as a neoadjuvant treatment for premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer. The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density.