Atossa Therapeutics Inc (NASDAQ:ATOS)'s selective estrogen receptor modulator (Z)-endoxifen is being evaluated in a Phase 2 study aimed at preventing the progression of ductal carcinoma in situ (DCIS), the presence of abnormal cells inside a milk duct in the breast, to breast cancer.
The Phase 2 platform study, titled “Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS),” has been initiated by Quantum Leap Healthcare Collaborative (QLHC), a charitable organization established in 2005 as a collaboration between medical researchers at the University of California, San Francisco and Silicon Valley entrepreneurs.
In addition to evaluating Atossa’s (Z)-endoxifen, the study will also evaluate Havah Therapeutics’ proprietary combination of testosterone and anastrozole HAVAH T+Ai and Menarini Group subsidiary Stemline Therapeutics’ Food and Drug Administration (FDA)-approved oral selective estrogen receptor degrader ORSERDU.
QLHC on Monday launched enrollment for the trial, which will enroll more than 300 patients across 40 sites in the United States.
Atossa Therapeutics, Havah Therapeutics, and Stemline Therapeutics are all developing alternatives for DCIS patients and are providing their respective agents for assessment in the trial.
To date Atossa’s (Z)-endoxifen has demonstrated promising results in the treatment of breast cancer and for the treatment of other solid tumors.
QLHC’s study will offer patients with DCIS up to six months of endocrine therapy with the intent to forgo surgery and instead be monitored via long-term active surveillance, QLHC said.
The current standard of care for DCIS is surgery, however many patients never progress to breast cancer meaning that some are often over-treated with invasive procedures, it noted.
"DCIS indicates the very earliest, non-invasive stage of the disease, that's why it is important for us to seek out alternative therapies for DCIS patients and find ways to reduce toxicity and unnecessary surgeries,” lead investigator and QLHC founder Dr. Laura Esserman said in a statement.
“We are excited to partner with three innovative companies to explore new treatments for this large and often over-treated patient population.”
Atossa is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer.
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