Atossa Therapeutics President & CEO Dr. Steven Quay joins Natalie Stoberman from the Proactive studios to discuss the latest progress in its Phase 2 I-SPY 2 clinical trial where six patients have been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, achieving a 30 percent enrollment rate within two months of the trial commencing.
Dr. Quay says 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 is expected to enroll approximately 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP). 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.