SEATTLE - Atossa Therapeutics, Inc. (NASDAQ: ATOS), a developer of innovative medicines in oncology, particularly for breast cancer, has announced the initiation of a Phase 2 trial involving a non-surgical approach for treating Ductal Carcinoma In Situ (DCIS). The first patient received a dose of Atossa's proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, as part of the RECAST DCIS study, which aims to assess the possibility of long-term active surveillance of DCIS without surgery.
DCIS, considered the earliest form of breast cancer, is typically treated with surgery, followed by radiation and hormone therapy. However, Atossa's President and CEO, Dr. Steven Quay, suggests that this standard of care may be overly aggressive, noting that most DCIS cases do not progress to invasive breast cancer if left untreated. The RECAST DCIS trial, sponsored by Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative, seeks to enroll up to 110 patients to evaluate the efficacy of (Z)-endoxifen in potentially replacing the current treatment approach.
The study will focus on assessing imaging and molecular-based biomarkers to identify patients with low-risk lesions who could avoid surgery. This aligns with the broader goal of reducing overtreatment in DCIS cases. (Z)-endoxifen, a metabolite of the FDA-approved SERM tamoxifen, has shown promise in prior Phase 1 and small Phase 2 studies for its tolerability and concentration-dependent therapeutic effects.
The RECAST DCIS trial is one of four ongoing Phase 2 trials involving (Z)-endoxifen, including studies on women with measurable breast density and ER+/HER2- breast cancer. The compound is protected by three issued U.S. patents and numerous pending applications.
This news is based on a press release statement from Atossa Therapeutics, Inc. The company's efforts to develop a non-surgical treatment for DCIS could potentially offer a less invasive option for patients diagnosed with this type of breast cancer.
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