Atossa Therapeutics Shares Promising Data on Z-Endoxifen Safety

Exciting Updates from Atossa Therapeutics on Breast Cancer Treatment

Atossa Therapeutics, Inc. (Nasdaq: ATOS) has recently announced the presentation of significant data from its Phase 2 EVANGELINE trial at a major breast cancer symposium. This clinical-stage biopharmaceutical company specializes in developing innovative treatments for oncology, particularly focusing on breast cancer, an area that has long demanded advancements in patient care.

About the EVANGELINE Trial

The EVANGELINE trial is a randomized, Phase 2 non-inferiority study examining the efficacy and safety of (Z)-endoxifen, a selective estrogen receptor modulator (SERM), as a neoadjuvant treatment for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative breast cancer. The drug aims to offer a more effective solution for patients who often face limited options in their treatment plans.

Key Presentation Details

At the upcoming San Antonio Breast Cancer Symposium, three compelling posters highlighting pharmacokinetic and tolerability data will be showcased. These findings provide useful insights into the effects of (Z)-endoxifen on patients, aiming to create a better understanding of its potential benefits.

Poster Insights on (Z)-Endoxifen

The first poster presents critical data regarding pharmacokinetic (PK) evaluation. During the trial, different doses of (Z)-endoxifen (40 mg and 80 mg, with and without goserelin) were assessed. Notably, 50% of patients receiving the higher dose with goserelin reached the target plasma concentration levels, indicating a promising response rate.

Tissue Penetration and Antitumor Activity

The results also indicate impressive tissue penetration, with the 80 mg dose achieving levels in tissues that considerably exceeded plasma levels, thus enhancing the likelihood of effective tumor targeting. Moreover, a remarkable response rate of above 85% was noted across various dosing levels, confirming the drug's capabilities even when ovarian function suppression was present.

Quality of Life Data from the Trial

Another poster focuses on quality of life (QOL) measures, emphasizing that (Z)-endoxifen is generally well-tolerated with low-grade side effects reported by patients. Symptoms experienced were manageable, which is crucial as maintaining quality of life is often a priority for patients undergoing treatment.

Next Steps for EVANGELINE

The final poster outlines the next phase of the EVANGELINE trial, which plans to compare (Z)-endoxifen to other options, including exemestane. With the trial now moving ahead with a clear design and defined dosing strategy, recruitment for participants is expected to begin soon, aiming to fulfill the pressing need for effective breast cancer treatments.

Executive Insights

Dr. Steven Quay, the President and CEO of Atossa Therapeutics, expressed optimism regarding the data being presented. He noted that these findings not only advance their understanding of (Z)-endoxifen's effects but also position it as a promising candidate for improving outcomes in patients with ER+/HER2- breast cancer.

About (Z)-Endoxifen

(Z)-endoxifen is recognized for its powerful action against estrogen receptors and demonstrates potential benefits in patients who have become resistant to other hormonal therapies. Its capability to target oncogenic proteins further solidifies its significance in ongoing clinical evaluations.

About Atossa Therapeutics

Atossa Therapeutics is dedicated to developing groundbreaking treatments that address significant unmet medical needs in oncology, particularly focusing on breast cancer prevention and treatment strategies. Their approach, exemplified by their ongoing studies with (Z)-endoxifen, highlights their commitment to innovation and patient-centric care.

Frequently Asked Questions

What is the purpose of the EVANGELINE trial?

The EVANGELINE trial aims to evaluate the safety and efficacy of (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative breast cancer.

What findings were highlighted in the pharmacokinetic data?

The pharmacokinetic data presented indicated that 50% of patients receiving the 80 mg dose with goserelin achieved the target plasma concentration, which is essential for effective treatment.

How does (Z)-endoxifen impact patient quality of life?

Patients reported that (Z)-endoxifen was well-tolerated, with most side effects being low grade and manageable, allowing them to maintain a reasonable quality of life during treatment.

What are the next steps for Atossa Therapeutics?

Atossa is preparing to initiate the randomized phase of the EVANGELINE trial, with recruitment expected to start soon to further explore the potential of (Z)-endoxifen.

How is (Z)-endoxifen different from other breast cancer treatments?

(Z)-endoxifen offers powerful estrogen receptor inhibition and has shown efficacy in patients resistant to other therapies. It is also designed to minimize side effects commonly associated with standard treatments.

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