Atossa Therapeutics Presents Data from 40mg Cohort of Phase 2 EVANGELINE Clinical Trial Showing 100% Disease Control Rate After 24-Weeks of Treatment with (Z)-Endoxifen - Seite 2

“The 40mg EVANGELINE data is extremely encouraging as it shows that (Z)-endoxifen can not only stop ER+ breast cancer from growing, but it can also shrink or eliminate the tumor, as measured by MRI imaging,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “The depth of response at 40mg may even improve in the next phase of the study where we are now treating women with 80mg of (Z)-endoxifen daily. We expect this dose to deliver the optimal steady-state plasma concentrations required to fully target PKCβ1 inhibition and further enhance (Z)-endoxifen’s antitumor efficacy.”

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.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast cancer is estrogen receptor positive (ER+). Ovarian function suppression (OFS), when combined with either tamoxifen or an aromatase inhibitor, is the current standard of care for the endocrine management of stage 2 and 3 premenopausal ER+/HER2- breast cancer.