Atossa Therapeutics Reveals Promising Data from Endoxifen Study

Atossa Therapeutics Shares Groundbreaking Results from Phase 2 Trial

Atossa Therapeutics, Inc. (Nasdaq: ATOS) has made significant strides forward in the fight against breast cancer. The company recently announced comprehensive results from its Phase 2 KARISMA-Endoxifen study, which have generated hopeful insights for premenopausal women at elevated risk for developing breast cancer. This innovative trial investigated the efficacy of (Z)-endoxifen, known for its potential to serve as a well-tolerated preventative treatment.

Key Findings from the Study

The KARISMA study enrolled 240 premenopausal women aged between 40 to 55 years, divided into three groups: one that received a placebo, another taking 1 mg of (Z)-endoxifen, and a third group with 2 mg of the drug. Each participant was monitored over a six-month period. The primary goal was to evaluate alterations in mammographic breast density (MBD)—a significant contributor to breast cancer risk—alongside monitoring safety and tolerability.

Statistically Significant Results

Results indicated that the cohort receiving the 1 mg dosage experienced a significant reduction in mammographic breast density by 17.3 percentage points, while the group on 2 mg saw a reduction of 23.5 percentage points. These findings were statistically significant, with p-values demonstrating strong evidence (p < 0.01). In contrast, the placebo group recorded negligible changes of just 0.27 percentage points. Notably, this study highlighted that the efficacy of lower doses of (Z)-endoxifen did not come with an increased risk of adverse events compared to the placebo group.

Clinical Importance of Research Findings

Dr. Steven Quay, the President and CEO of Atossa, expressed optimism regarding these findings. He emphasized the possible applications of (Z)-endoxifen as a preventative treatment, particularly for women with dense breast tissue. The ability to achieve significant reductions in MBD with a minimal dose while avoiding some of the more serious side effects associated with other anti-estrogen treatments suggests this could be a crucial advancement in preventive breast cancer therapies.

MBD and Its Impact on Breast Cancer

Mammographic breast density is a well-known independent risk factor for breast cancer. It complicates tumor detection, making mammograms less effective and increasing the likelihood of developing the disease. The results from the KARISMA study align with earlier research that focuses on the benefits of tamoxifen while demonstrating that (Z)-endoxifen can provide similar or even enhanced benefits without the associated risks.

Presentation of Trial Results

These promising results will be presented at the upcoming San Antonio Breast Cancer Symposium during a Poster Spotlight Session, allowing experts to discuss the implications and future of (Z)-endoxifen in breast cancer prevention.

Details of the Presentation

The poster session will highlight the title "Primary Breast Cancer Prevention Using Oral Endoxifen" and will take place at 5:30 PM on a designated date. The specifics of the poster presentation can spark engaging discussions among researchers, physicians, and industry experts attending the symposium.

About (Z)-Endoxifen

(Z)-Endoxifen is recognized as a potent Selective Estrogen Receptor Modulator (SERM) with the ability to inhibit estrogen receptors effectively. Its unique mechanism not only facilitates estrogen receptor degradation but also targets known oncogenic proteins, enhancing its therapeutic profile. Recent studies have shown that (Z)-endoxifen delivers greater agonist effects on bone while minimizing endometrial proliferation, an advantage over traditional treatments like tamoxifen.

Ongoing Development of (Z)-Endoxifen

Atossa Therapeutics is committed to advancing this drug, currently formulating a specialized oral version designed to bypass the acidic environment of the stomach, which could deactivate a significant amount of the drug. The company is actively pursuing multiple Phase 2 trials to explore the breadth of (Z)-endoxifen’s efficacy across various breast cancer scenarios.

Conclusion and Future Prospects

The findings from the KARISMA trial signal an optimistic trend for breast cancer prevention treatments. Atossa Therapeutics remains devoted to exploring innovative solutions for unmet medical needs in oncology, particularly in the field of preventive therapies using (Z)-endoxifen. As trials continue to unfold, the potential benefits for women at risk of breast cancer become clearer, enhancing hope for safer, more effective preventive measures.

Frequently Asked Questions

1. What is the primary focus of the Atossa Therapeutics study?

The study primarily focuses on the effectiveness of (Z)-endoxifen in reducing mammographic breast density in premenopausal women at risk for breast cancer.

2. How does (Z)-endoxifen compare to traditional therapies?

(Z)-Endoxifen offers comparable benefits to traditional therapies like tamoxifen but with fewer side effects and enhanced safety profiles.

3. What were the results of the study regarding mammographic breast density?

The 1 mg dose of (Z)-endoxifen reduced mammographic breast density by 17.3 percentage points, while the 2 mg dose achieved a reduction of 23.5 percentage points, both statistically significant.

4. Where will the study results be presented?

The results will be presented at the 2024 San Antonio Breast Cancer Symposium during a Poster Spotlight Session.

5. What is the significance of mammographic breast density in breast cancer?

Mammographic breast density is a crucial risk factor as it complicates the detection of tumors on mammograms and is linked to a higher risk of developing breast cancer.

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