New Breakthrough in Breast Cancer Research from Atossa

New Study Proposal Tackles Interval Breast Cancer in Women

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a prominent name in the biopharmaceutical field, has recently shared an ambitious initiative aimed at enhancing breast cancer prevention. During a significant event, the American Association for Cancer Research (AACR) Annual Meeting, Atossa outlined its plans for an innovative Phase 3 clinical study known as SMART 2.0. This proposed trial is designed to explore the efficacy of oral (Z)-endoxifen, a leading Selective Estrogen Receptor Modulator (SERM), in significantly reducing interval breast cancer among high-risk women, a demographic identified through advanced mammographic screening techniques.

The Challenge of Interval Breast Cancers

Interval breast cancers refer to diagnoses made between routine mammography sessions. These cases tend to be more aggressive and harder to treat than those detected during regular screenings. A significant issue causing these delayed diagnoses is mammographic density, which is a modifiable risk factor for breast cancer. Research has indicated that (Z)-endoxifen, similar to tamoxifen, may reduce breast density and enhance the sensitivity of mammograms, providing hope for more accurate and timely diagnoses. Despite the benefits of tamoxifen, concerns regarding its side effects have tempered its use.

Innovative Approach with Z-Endoxifen

Atossa's pioneering approach includes the use of low-dose (1mg) Z-endoxifen, which has demonstrated a nearly 20 percent reduction in mammographic density within six months, while exhibiting minimal side effects comparable to a placebo in the Phase 2 KARISMA trial. The proposed SMART 2.0 study will select participants using an AI Risk model, randomly assigning them to either treatment or placebo groups. Over two years, researchers will assess the effectiveness of (Z)-endoxifen, focusing on the reduction of interval breast cancer occurrences and overall tolerability compared to the placebo.

A Promising Future for Breast Cancer Prevention

According to Steven C. Quay, CEO of Atossa Therapeutics, this SMART 2.0 study represents a significant leap in breast cancer prevention. By strategically targeting mammographic density with (Z)-endoxifen, Atossa aims to pioneer a safer and more effective preventive solution for women at heightened risk of developing breast cancer. This trial has the potential to generate the key data necessary for regulatory approval, ultimately aiming to provide an innovative preventative treatment option that could minimize the risk of interval breast cancer.

Exploring (Z)-Endoxifen Further

(Z)-endoxifen stands out as one of the most effective SERMs known for its estrogen receptor inhibition capabilities and may facilitate the degradation of estrogen receptors in the body. This compound is significant not only for its powerful anti-estrogen effects but also because it interacts with PKC?1, a known oncogenic protein, at feasible blood concentration levels. Remarkably, (Z)-endoxifen is believed to maintain similar or even enhanced bone health benefits while minimizing the endometrial proliferation typically associated with standard treatments such as tamoxifen.

About Atossa Therapeutics

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is committed to revolutionizing breast cancer treatment through exceptional scientific advancements and patient-centered solutions. The company's flagship product, (Z)-endoxifen, serves as a highly potent SERM intended for various stages of breast cancer management, encompassing prevention, neoadjuvant, adjuvant, and metastatic treatment. With a strong commitment to developing robust clinical research programs, Atossa endeavors to improve patient outcomes and create substantial value for its shareholders.

Frequently Asked Questions

What is the SMART 2.0 study?

The SMART 2.0 study is a proposed Phase 3 clinical trial by Atossa Therapeutics to evaluate the effectiveness of oral (Z)-endoxifen in reducing interval breast cancer in high-risk women.

Why is interval breast cancer a concern?

Interval breast cancer is diagnosed between regular mammogram screenings and is often more aggressive and difficult to treat, making timely detection crucial.

How does (Z)-endoxifen work?

(Z)-endoxifen acts as a Selective Estrogen Receptor Modulator that inhibits estrogen receptors and reduces breast density, potentially improving mammogram sensitivity.

What outcomes does the SMART 2.0 trial aim to measure?

The trial aims to measure the relative reduction in interval breast cancer incidence and tolerability of (Z)-endoxifen compared to a placebo over a period of two years.

What is the significance of Atossa Therapeutics?

Atossa Therapeutics is dedicated to transforming breast cancer treatment through innovative therapies, with a strong focus on developing (Z)-endoxifen for prevention and treatment.

About The Author

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