Atossa, Quantum Leap dose six patients in (Z)-endoxifen arm of I-SPY 2 trial

Atossa Therapeutics and Quantum Leap Healthcare Collaborative announced that six patients have been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator, (Z)-endoxifen, in the ongoing Phase 2 I-SPY 2 clinical trial. (Z)-endoxifen is being evaluated as a neoadjuvant treatment for 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. 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 Cancer Biomarkers Consortium. The (Z)-endoxifen treatment arm, which is expected to enroll approximately 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol. Patients will receive 10 mg of (Z)-endoxifen daily for up to 24 weeks prior to surgery. Currently, there are 41 I-SPY 2 sites, all of which have the EOP program open.