Breast cancer continues to be a significant global health concern, particularly among pre-menopausal women with Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. Atossa Therapeutics, a clinical stage biopharmaceutical company, is working towards addressing this unmet medical need through its Phase 2 EVANGELINE clinical trial. The trial aims to evaluate the efficacy and safety of Atossa’s patented Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, in combination with exemestane and goserelin as a neoadjuvant treatment for this specific patient population.
Enrollment of 80mg Pharmacokinetic Run-In Cohort
Atossa Therapeutics recently announced the successful completion of enrollment for the 80mg pharmacokinetic (PK) run-in cohort of the EVANGELINE study. This represents a major milestone for the company, as the trial progresses towards assessing the effectiveness of (Z)-endoxifen as a potential neoadjuvant treatment option.
The EVANGELINE Study
EVANGELINE is a randomized non-inferiority trial that aims to compare the efficacy and safety of (Z)-endoxifen in combination with exemestane and goserelin against the standard of care for pre-menopausal women with Grade 1 or 2 ER+ / HER2- breast cancer. Neoadjuvant therapy, which is administered before surgery, has shown promise in improving outcomes and increasing the possibility of breast-conserving surgery. Atossa’s unique approach of combining a SERM with exemestane and goserelin holds potential to enhance treatment outcomes in this patient population.
The Role of (Z)-Endoxifen
(Z)-endoxifen, Atossa’s proprietary SERM, is being investigated due to its potential to inhibit estrogen activity in breast tissue, thereby reducing the growth of ER+ breast cancer. This novel approach aims to target the specific biological characteristics of the tumor, leading to improved treatment outcomes and reducing the need for more aggressive treatment options.
Progressing Towards Better Breast Cancer Care
By fully enrolling the 80mg PK run-in cohort, Atossa Therapeutics demonstrates its commitment to advancing breast cancer care. The completion of this phase brings the company closer to gathering crucial data regarding the safety and efficacy of (Z)-endoxifen in combination with exemestane and goserelin. If successful, this treatment could potentially improve the neoadjuvant therapy landscape for pre-menopausal women with ER+ / HER2- breast cancer.
Conclusion:
Atossa Therapeutics’ Phase 2 EVANGELINE trial represents a significant step forward in the development of innovative treatment options for pre-menopausal women with ER+ / HER2- breast cancer. The enrollment of the 80mg PK run-in cohort is a notable accomplishment, bringing us closer to understanding the potential of (Z)-endoxifen as a neoadjuvant treatment. This trial holds promise to improve treatment outcomes, reduce the necessity for more invasive surgical options, and ultimately provide hope for patients facing this challenging disease.
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