Atossa Therapeutics Inc (NASDAQ:ATOS) announced that the first patient has been dosed with its proprietary selected estrogen receptor modulator (Z)-endoxifen in its Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS) Phase 2 study.
DCIS is considered the earliest form of breast cancer, usually found during breast cancer screening. It is non-invasive and has a low risk of becoming invasive. The current standard of care treatments include surgery, radiation therapy and/or hormone therapy.
Atossa highlighted that its study is designed to offer women diagnosed with DCIS up to six months of neoadjuvant endocrine therapy to determine their suitability for long-term active surveillance without surgery. It aims to enroll up to 110 patients.
“DCIS 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,” Atossa CEO Dr Steven Quay explained.
Quay said this was an “overly aggressive treatment approach,” especially when considering that 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,” he said.
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.