Atossa Therapeutics Announces First Patient Dosing of (Z)-Endoxifen in the Ongoing RECAST DCIS Study

SEATTLE, Feb. 22, 2024 (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 focus on breast cancer, today announced that the first patient has been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, in the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS) study. RECAST DCIS is an ongoing Phase 2 platform study designed to offer women diagnosed with DCIS six months of neoadjuvant endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.

A short 'explainer' video about Ductal Carcinoma In Situ and the RECAST DCIS study can be found here: DCIS Video Explainer.

“Ductal Carcinoma In Situ is pre-invasive cancer, but the current standard of care is to treat it like early-stage invasive breast cancer, which for most patients involves surgery, followed by radiation treatment for three to four weeks and finally hormone therapy for five years,” Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “This is an overly aggressive treatment approach, especially when you consider most DCIS cases will not progress to invasive breast cancer if left untreated. We feel treatment with (Z)-endoxifen has the potential to replace the current standard of care, which would spare a significant percentage of patients diagnosed with DCIS from undergoing aggressive, invasive, unnecessary treatment.”

The RECAST DCIS trial is sponsored and operated by Quantum Leap Healthcare Collaborative, which was established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Participants in the study will be treated with up to six months of endocrine therapy with the intent to forego surgery and instead be monitored via long-term active surveillance. A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery. RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting. The (Z)-endoxifen study arm is expected to enroll up to 110 patients.