Atossa Therapeutics, a clinical-stage biopharmaceutical company focused on breast cancer treatment, has announced protocol changes for a clinical trial evaluating the combination of their proprietary drug, (Z)-endoxifen, and abemaciclib (VERZENIO). The study aims to investigate the neoadjuvant treatment potential of this combination for women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. This development follows the initiation of a separate study and the successful completion of a five-year (Z)-endoxifen treatment program under FDA-approved expanded access for a pre-menopausal patient.
Atossa Therapeutics, in collaboration with Quantum Leap Healthcare Collaborative, has initiated a new study to evaluate the efficacy of (Z)-endoxifen in combination with abemaciclib (VERZENIO). Abemaciclib is a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company. This trial targets women with ER+/HER2- breast cancer, with a focus on neoadjuvant treatment.
The recently updated protocol for this ongoing study aims to explore the potential benefits and synergistic effects of combining (Z)-endoxifen and abemaciclib. By inhibiting CDK 4/6, abemaciclib can potentially slow or halt the growth of ER+ breast cancer cells, while (Z)-endoxifen has shown promise in improving treatment response rates. The study’s is to assess the safety and efficacy of this combination therapy prior to surgery.
Prior to this announcement, Atossa Therapeutics had successfully completed a five-year (Z)-endoxifen treatment program under an FDA-approved expanded access program for a pre-menopausal patient. This patient, diagnosed with ER+/HER2- breast cancer, experienced no significant safety or tolerability issues throughout the treatment and remains cancer-free. This achievement further validates the therapeutic potential of (Z)-endoxifen in breast cancer management.
Conclusion:
Atossa Therapeutics, in collaboration with Quantum Leap Healthcare Collaborative, is making significant progress in the development of (Z)-endoxifen as a potential neoadjuvant treatment for women with ER+/HER2- breast cancer. The updated protocol for the ongoing clinical trial, in combination with the successful completion of a five-year treatment program, indicates promising results in terms of safety and efficacy.
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