Atossa Therapeutics Modifies Breast Cancer Trial with Increased (Z)-endoxifen Dose
Atossa Therapeutics has adjusted its ongoing clinical trial by augmenting the dose of (Z)-endoxifen and blending it with Eli Lilly's abemaciclib to target ER+/HER2- breast cancer. This alteration is based on favorable results from the Phase II EVANGELINE study, demonstrating a significant reduction in the cellular proliferation marker Ki-67 and the size of tumors. The updated trial will encompass about 80 participants across two cohorts, covering both pre- and post-menopausal women. Notably, premenopausal women in the second cohort will also undergo ovarian function suppression to facilitate direct outcome comparisons. Atossa's CEO, Steven Quay, expressed enthusiasm concerning the protocol update and the backing from Eli Lilly, highlighting the positive safety profile and optimal drug concentrations achieved with the increased (Z)-endoxifen dosage.
Key Takeaways
- Atossa Therapeutics has raised the dose of (Z)-endoxifen to 80mg in the breast cancer trial.
- The trial now comprises 80 participants across two cohorts, focusing on ER+/HER2- breast cancer.
- The EVANGELINE study demonstrated a 92% reduction in Ki-67 and a 37% decrease in tumor size.
- Premenopausal women in the second cohort will receive ovarian function suppression.
- Atossa and Eli Lilly are collaborating to supply drugs for the clinical trial.
Analysis
Atossa Therapeutics' enhanced trial, incorporating elevated (Z)-endoxifen doses with Eli Lilly's abemaciclib, is aimed at optimizing the treatment of ER+/HER2- breast cancer following the encouraging outcomes of the EVANGELINE study. This strategic move not only strengthens Atossa's market position but also underscores Eli Lilly's commitment to innovative cancer therapies. Despite anticipated short-term escalations in drug costs and trial complexities, the long-term benefits include potential regulatory approvals and expanded market share. This development underscores the pharmaceutical industry's dynamic approach to refining cancer treatments, with significant implications for patient outcomes and industry competition.
Did You Know?
- (Z)-endoxifen: (Z)-endoxifen, a metabolite of tamoxifen, is a drug commonly used to treat estrogen receptor-positive (ER+) breast cancer and is believed to have a more potent anti-estrogenic effect than tamoxifen itself. The increase in dose from 40mg to 80mg daily aims to enhance its efficacy in reducing tumor size and cellular proliferation.
- abemaciclib: Abemaciclib, a CDK4/6 inhibitor, is used in combination with other therapies to treat certain types of breast cancer. It works by blocking the activity of cyclin-dependent kinases 4 and 6, enzymes that promote cell division, thereby slowing tumor growth. Combining it with (Z)-endoxifen in this trial aims to explore a synergistic effect to improve treatment outcomes for ER+/HER2- breast cancer.
- Ki-67: Ki-67 is a protein used as a marker of cell proliferation, commonly assessed in cancer research and clinical practice to gauge tumor aggressiveness and the effectiveness of treatments. A significant reduction in Ki-67 levels, as observed in the EVANGELINE study, indicates a decrease in the rate of tumor cell growth, suggesting that the treatment is slowing or stopping tumor progression.