SEATTLE, April 09, 2024 - Atossa Therapeutics, a leading clinical stage biopharmaceutical company focused on breast cancer therapeutics, has unveiled encouraging results from its Phase 2 EVANGELINE clinical trial. The trial evaluated the neoadjuvant treatment, (Z)-endoxifen, in pre-menopausal women diagnosed with Grade 1 or 2 Estrogen Receptor positive (ER+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
The promising safety and efficacy data presented by Atossa Therapeutics have shown a remarkable 100% disease control rate after a 24-week treatment period with (Z)-endoxifen. This ground-breaking finding marks a significant milestone in the quest to combat breast cancer, which affects millions of women globally.
Neoadjuvant therapy involves administering treatments before surgery, with the primary goal of reducing tumor size and improving surgical outcomes. ER+ and HER2- breast cancers are commonly associated with a higher risk of relapse and poorer prognosis compared to other subtypes. Therefore, the successful development of a neoadjuvant treatment targeting this population presents a major advancement in breast cancer therapy.
Atossa’s EVANGELINE study focuses on evaluating (Z)-endoxifen, a novel treatment candidate with the potential to revolutionize pre-menopausal breast cancer therapy. The drug is designed to inhibit the growth of ER+ cancer cells while minimizing adverse effects commonly experienced with conventional therapies.
The Phase 2 EVANGELINE trial enrolled a cohort of pre-menopausal women with ER+/HER2- breast cancer and administered a 40mg dose of (Z)-endoxifen. The study’s primary was to assess disease control rate, a critical measure of treatment effectiveness. Achieving a 100% disease control rate is a significant outcome, indicating that (Z)-endoxifen may have the potential to deter disease progression effectively.
These highly encouraging results could potentially pave the way for (Z)-endoxifen’s approval as a neoadjuvant therapy for pre-menopausal women with ER+/HER2- breast cancer. If approved, the treatment could enhance patient outcomes by reducing tumor burden prior to surgery, ultimately improving long-term survival rates.
Atossa Therapeutics’ commitment to breast cancer research and development is evident in their focus on innovative medicines addressing significant unmet medical needs. The EVANGELINE trial’s exceptional results reinforce their dedication to revolutionizing breast cancer treatment for women worldwide.
In conclusion, the Phase 2 EVANGELINE trial has demonstrated the remarkable potential of (Z)-endoxifen as a neoadjuvant therapy for pre-menopausal women with ER+/HER2- breast cancer, achieving an unprecedented 100% disease control rate. These promising results offer hope for improved outcomes in the fight against breast cancer, and further studies are eagerly awaited to confirm the efficacy and safety of (Z)-endoxifen.
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