Business
Atossa Therapeutics Announces First Quarter 2023 Financial Results and Provides Corporate Update
Two Phase 2 trials investigating (Z)-endoxifen in neoadjuvant setting initiated and are enrolling patientsFull enrollment of Phase 2 KARISMA mammographic
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"Two Phase 2 trials investigating (Z)-endoxifen in neoadjuvant setting initiated and are enrolling patientsFull enrollment of Phase 2 KARISMA mammographic breast density study expected by end of 2023Ended first quarter 2023 with $103.9 million of cash and cash equivalents and no debt SEATTLE, May 15, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a current focus on breast cancer, today announces financial results for the fiscal quarter ended March 31, 2023, and provides an update on recent company developments. Key developments from Q1 2023 and year to date include: Initiation of and First Patient Dosed in Phase 2 EVANGELINE Study – EVANGELINE (Endoxifen Versus exemestANe GosEreLIn), is a Phase 2 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. Participants receive neoadjuvant treatment for up to 24 weeks, followed by surgery.Initiation of New Study Arm in the Ongoing Phase 2 I-SPY 2 Clinical Trial – I-SPY 2 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. Approximately 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery.Additional Intellectual Property Protection for (Z)-endoxifen – The United States Patent and Trademark Office granted a new patent (No. 11,572,334) directed to (Z)-endoxifen encapsulated in an enteric capsule. Enteric capsules have an acid resistant coating to prevent them from dissolving when they pass through the stomach. Enteric capsules are dissolved when they pass through an alkaline environment, which is usually when they reach the small intestine. Delivering oral (Z)-endoxifen via an enteric capsule prevents breakdown of the (Z)-endoxifen in the stomach.Poster Presentation at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting – A Trial in Progress poster for the Phase 2 clinical study of (Z)-endoxifen in premenopausal women with early stag...