Atossa Therapeutics Announces Full Enrollment of (Z)-Endoxifen Arm of I-SPY 2 Clinical Trial

About this update from Atossa Therapeutics, Inc.

[{"type":"text","content":"SEATTLE, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today 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. “We are excited that the (Z)-endoxifen arm of the I-SPY 2 study has fully enrolled and look forward to seeing data from this study in the second half of 2024,” said Steven Quay, MD, PhD, Atossa’s President and Chief Executive Officer. “Estrogen receptor positive breast cancer accounts for over 80% of all breast cancer diagnoses and unfortunately, the current neoadjuvant treatment options for these patients are sub-optimal. Treatment with (Z)-endoxifen has the potential to down-stage the tumor, improve tumor resectability and reduce the incidence of breast cancer recurrence, all while demonstrating a far superior safety and tolerability profile compared to aromatase inhibitors and systemic chemotherapy. 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)-endoxifen daily for up to 24 weeks prior to surgery. About (Z)-Endoxifen(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein....

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