Atossa Genetics opens enrollment in Phase 2 study of oral Endoxifen
Atossa Genetics announced that it has opened a Phase 2 study of its proprietary oral Endoxifen to treat breast cancer in the "window of opportunity" setting, which is the period between diagnosis of breast cancer and surgery. The Pilot Phase of the study will initially enroll up to eight newly-diagnosed patients with Estrogen Receptor Positive and HER2 negative stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients will receive Atossa's proprietary oral Endoxifen for at least 21 days from the time of diagnosis up to the day of surgery. Provided tumor activity reduction is demonstrated in at least two patients, an additional 17 patients will be enrolled for a total of 25. The U.S. FDA has provided a guidance document on "window of opportunity" or neoadjuvant studies entitled "Guidance for Industry Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval." The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67, which is a marker of cellular proliferation. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored.