Atossa Therapeutics Inc (NASDAQ:ATOS) announced that it has fully enrolled the (Z)-endoxifen arm of its ongoing Phase 2 I-SPY 2 clinical trial targeting breast cancer.
The study is evaluating Atossa’s selective estrogen receptor modulator (Z)-endoxifen as a neoadjuvant treatment for newly diagnosed estrogen receptor-positive invasive breast cancer.
The (Z)-endoxifen arm enrolled 20 patients who will receive 10 milligrams of the therapeutic daily for up to 24 weeks before surgery.
Data from the study – a collaboration between major cancer research centers across the US, Quantum Leap Healthcare, the US Food and Drug Administration, and the Foundation for the National Institutes of Health Cancer Biomarkers Consortium - is expected in the second half of 2024.
“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,” Atossa CEO Steven Quay said in a statement.
He believes that Atossa’s therapy could transform the treatment paradigm for the hundreds of thousands of women diagnosed with estrogen receptor-positive breast cancer every year.
“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,” he said.
Shares of Atossa moved higher on the news, up 4.9% at $0.94 before Wednesday’s opening bell in New York.
Atossa is a clinical-stage biopharmaceutical company developing innovative medicines in areas of unmet medical need in oncology with a focus on breast cancer.