Atossa Genetics is passionate about improving breast health and the overall well-being and health of women and men.
Our key objectives are to advance our pharmaceutical candidates through Phase 2 trials and then evaluate further development independently or with partners.
We believe our patented intraductal microcatheters may be useful in delivering a number of therapeutics directly to the breast tissue by the milk ducts. Doing so may provide a higher concentration of the therapeutic to the targeted tissue rather than distributing it throughout the body.
The initial drug we are studying using our microcatheters for intraductal delivery is fulvestrant. Fulvestrant is FDA-approved for metastatic breast cancer. It is administered as a monthly intramuscular injection of two injections, typically into the buttocks. We own one issued patent and several pending applications directed to the treatment of breast conditions, including cancer, by the intraductal administration of therapeutics, including fulvestrant.
To support this development program, we have successfully produced microcatheters for the fulvestrant Phase 2 clinical trial. In March 2016, we opened enrollment in the study ATOS-2015-007, which is being conducted by The Columbia University Medical Center Breast Cancer Program. This trial is a Phase 2 study in women with ductal carcinoma in situ (DCIS) or Stage 1 or 2 invasive ductal carcinoma scheduled for mastectomy or lumpectomy within 30 to 45 days. This study is assessing the safety, tolerability and distribution of fulvestrant when delivered directly into breast milk ducts of these patients compared to those who receive the same product intramuscularly. Of the 30 patients required for full enrollment, six will receive the standard intramuscular fulvestrant dose of 500 mg and 24 will receive up to 500 mg of fulvestrant by intraductal instillation utilizing our microcatheter device.
The primary endpoint of the clinical trial is to compare the safety, tolerability and distribution of fulvestrant between the two routes of administration (intramuscularly or intraductally). The secondary endpoint of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimens. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant.
In June 2016, we announced our oral endoxifen program intended for breast cancer patients who are refractory to tamoxifen. Tamoxifen is a “pro-drug”, meaning that it must be metabolized into active constituents, in order for it to be effective. It is an FDA approved drug for breast cancer patients to prevent recurrence as well as new breast cancer. Endoxifen is one of the most active tamoxifen metabolites. Of the estimated over one million patients annually in the United States who take tamoxifen, up to 50% of those patients are refractory, meaning they receive little or no benefit from the drug, 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.