Atossa Genetics is a clinical-stage pharmaceutical company focused on the development of novel therapeutics and delivery methods for the treatment of breast cancer and other breast conditions.
Our leading program uses our patented intraductal microcatheters that deliver pharmaceuticals through the breast milk ducts. We initiated a Phase 2 clinical study in March 2016 using our microcatheters to deliver fulvestrant as a potential treatment of ductal carcinoma in-situ, or DCIS, and breast cancer. This study is being conducted by Columbia University Medical Center Breast Cancer Programs (New York). Oral endoxifen is our second development program. Endoxifen is an active metabolite of tamoxifen, an FDA approved drug for breast cancer patients to prevent recurrence as well as new breast cancer. We are developing oral endoxifen for breast cancer patients who are refractory to tamoxifen which means they get little or no benefit from the drug. It is estimated that over one million people take tamoxifen annually in the United States and that up to 50% of those patients are refractory for any number of reasons, including low levels of a liver enzyme. We expect to initiate a Phase 2 clinical study for this drug in 2017.
In late 2015, we completed a strategic assessment and restructuring aimed at focusing our resources on our pharmaceutical programs. On December 16, 2015 we sold approximately 81% of the capital stock of the The National Reference Laboratory for Breast Health Inc. (the “NRLBH”), which had historically provided various diagnostic tests including for specimens collected with our breast aspirator devices.