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Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company") today announced its support of new guidelines released by the U.S. Preventive Services Task Force (USPSTF) recommending that women begin breast cancer screening starting at age 40. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
The updated guidelines recommend women undergo biennial mammography screening beginning at the age of 40 until the age of 74. The change to the recommended age comes in response to rising breast cancer rates among younger women and racial disparities in breast cancer diagnosis and mortality. The announced changes from USPSTF also come in advance of a September 2024 deadline mandated by U.S. FDA requiring mammogram facilities to provide women with detailed information regarding their breast density, as part of routine mammograms. Breast density is a significant independent risk factor for the development of breast cancer and can also decrease the effectiveness of mammograms in detecting cancerous lesions. Atossa Therapeutics recognizes the significance of these improved guidelines in empowering both healthcare providers and patients to make informed decisions regarding breast cancer screening and treatment.
Atossa is currently evaluating its lead asset, (Z)-endoxifen, in five Phase 2 clinical trials. One of those trials, the Karisma-Endoxifen study, is investigating (Z)-endoxifen's ability to reduce mammographic breast density in premenopausal women with measurable density. The trial fully enrolled in November 2023 and data is expected in the second half of 2024. Currently, there are no approved treatments to reduce breast density.
"The new guidelines will undoubtedly improve timely access to patient care and save lives by enabling earlier diagnosis and treatment of breast cancer," said Steven Quay, M.D., Ph.D., Atossa's President and Chief Executive Officer. "However, a bigger opportunity to help women is by developing therapies to prevent breast cancer from ever occurring. Half the women in the world over the age of 40 have dense breast tissue and women with very dense breasts are five-times more likely to get breast cancer than women with fatty breasts. Reducing breast density would not only make mammograms more effective, but more importantly, it could significantly reduce the likelihood that these women ever develop breast cancer."
About (Z)-Endoxifen
(Z)-endoxifen is the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and also causes estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.
Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach, as acidic conditions in the stomach convert a significant proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa's (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. (Z)-endoxifen is currently being studied in four Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa's (Z)-endoxifen is protected by three issued U.S. patents and numerous pending patent applications.
Posted In: ATOS
