Atossa Therapeutics, Inc has announced that it will present a Trial in Progress poster for the Phase 2 clinical study of (Z)-endoxifen in premenopausal women with early stage ER+ / HER2- breast cancer (EVANGELINE) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be taking place from June 2-6, 2023, in Chicago.
The clinical-stage biopharmaceutical company said the session, which will be presented by Dr Matthew Goetz of the Mayo Clinic, will take place on Sunday, June 4, 2023, from 8 AM to 11 AM Central Time.
“The EVANGELINE study is one of two ongoing Phase 2 trials investigating our proprietary (Z)-endoxifen as a neoadjuvant treatment for women with estrogen receptor positive breast cancer,” Atossa Therapeutics CEO Steven Quay said in a statement.
“We look forward to sharing more about this novel compound as we further our work to address unmet clinical needs across the continuum of breast cancer prevention and treatment,” Quay added.
Atossa noted the full abstract will become public at 5 PM EDT on May 25, 2023.
The primary objective of the EVANGELINE study is to determine whether the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen is non-inferior to the ESD rate following treatment with current standard of care, exemestane plus goserelin, according to the company.
Atossa added that it 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 greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen.
The company stated that it is currently studying (Z)-endoxifen in three Phase 2 studies: one in healthy women with measurable breast density and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer.
Atossa said its (Z)-endoxifen is protected by two issued US patents and numerous pending patent applications.
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer.
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