Approximately one in eight women will be diagnosed with breast cancer during their lifetime. Every two minutes an American woman is diagnosed with breast cancer; 40,000 die each year. Tamoxifen has been widely used for over 30 years for breast cancer. Additional research has shown that it is the metabolites of tamoxifen, of which endoxifen is the most active, that have potential therapeutic value.
Atossa is the only company in the WORLD attempting to conquer breast cancer in the manner that they have stated: “The best way to treat a disease is to prevent it in the first place.” They are developing a topical drug, a lotion applied to each breast, to treat a condition known as high breast density. Third-party studies have shown that high breast density increases the risk of developing breast cancer in some women. Breast density is diagnosed by mammography and approximately 10 million women have high density in the U.S. Tamoxifen has been demonstrated to reduce density and the incidence of breast cancer. However, tamoxifen can have serious side effects because, as a drug taken orally, it is delivered “systemically” meaning it travels throughout the body to other areas the drug is not needed. The goal of their topical endoxifen program is to treat high breast density with a local, topical drug.
Atossa is also developing a new way to deliver pharmaceuticals – through microcatheters (small tubes that can be inserted with anesthetic, through the nipple) so that pharmaceuticals can be targeted to the tissue where breast cancer actually grows.
About Atossa's Proprietary Endoxifen in Breast Cancer
Endoxifen is a cytochrome P450 mediated, active metabolite of tamoxifen, an FDA-approved drug to prevent new as well as recurrent disease in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Studies by others have shown that breast cancer patients with endoxifen levels of 30 nM and above have a lower risk for developing future breast cancer. Up to half of the patients taking tamoxifen do not produce therapeutic levels of endoxifen, frequently because of limited liver metabolism capability.
Studies by others indicate that endoxifen's molecular mechanisms of action are concentration dependent and different than that of other anti-estrogens, including fulvestrant. Pathway analysis of differentially regulated genes revealed substantial differences related to endoxifen concentrations including significant induction of cell cycle arrest and markers of apoptosis following treatment with high, but not low, concentrations of endoxifen.
Many patients taking tamoxifen eventually stop responding, becoming tamoxifen refractory. In a small study by others of oral endoxifen use by tamoxifen-refractory patients, endoxifen provided an acceptable safety profile and promising antitumor activity. Another class of drugs called aromatase inhibitors are also frequently used to treat breast cancer; however, they are not FDA-approved for use in pre-menopausal women and can only be given to pre-menopausal women in conjunction with drugs for ovarian suppression/oblation, which can cause cardiovascular and other toxicities. Additionally, 20-30% of those taking aromatase inhibitors may experience fractures, bone pain or osteoporosis.
Because of these potential advantages, Atossa is developing oral and topical forms of Endoxifen.
About Atossa's Phase 2 Study of Preoperative Systemic Oral Endoxifen
Atossa is currently conducting a Phase 2 study of its oral Endoxifen in Australia in the "window of opportunity" between diagnosis of breast cancer and surgery. "Once a patient is diagnosed with breast cancer, there is a window of time, typically a few weeks, before surgery is performed," commented Dr. Quay. "Our goal with this study is to show that our proprietary oral Endoxifen can modify the cancer activity in ER+ breast cancer during this 'window of opportunity.' Because our Phase 1 study indicated that our oral Endoxifen reaches therapeutic levels within 8 hours and therapeutic steady-state levels in only seven days, we are optimistic we can achieve a valuable treatment effect," added Dr. Quay.
The Pilot Phase of the study will initially enroll up to eight newly-diagnosed patients with ER+ and HER2 negative (HER2-) 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 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. The Phase 2 study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. CPR Pharma recently completed the successful Phase 1 study of Atossa's oral and topical Endoxifen in women.
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