Atossa Therapeutics Backs New FDA Rule to Enhance Breast Cancer Detection
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Atossa Therapeutics Endorses FDA’s New Mammography Requirements
SEATTLE – Atossa Therapeutics, Inc. (NASDAQ: ATOS) is excited to announce its support for the recent changes made by the U.S. Food and Drug Administration (FDA) regarding mammography regulations. This important development mandates that mammography facilities inform patients about breast density in an easily understandable manner, enhancing the dialogue around breast cancer risks.
Significance of Breast Density in Cancer Detection
The revised FDA rules are a significant advancement toward improving breast cancer awareness and detection. Breast density is recognized as a key risk factor in the development of breast cancer. It can sometimes hinder the detection of tumors during mammography scans, complicating diagnosis and timely interventions. By communicating breast density information better, the intent is to empower women to discuss additional screening options, such as ultrasound and MRI, with their healthcare providers. This is especially crucial for women with dense breast tissue who may be at a higher risk.
Expert Insights on the New Rule
Dr. Steven Quay, Atossa's President and CEO, expressed his views on this pivotal step: "The rule implemented by the FDA is a commendable initiative that advances patient outcomes through early detection and diagnosis. With the new requirements, patients can take proactive steps in managing their breast health, particularly regarding Estrogen Receptor-positive (ER+) breast cancers, where breast density plays an essential role in risk assessment."
Atossa’s Commitment to Innovation
Atossa is dedicated to enhancing the early detection and prevention of breast cancer, aligning perfectly with the spirit of the FDA's new regulations. The company is actively investigating its potential treatment, (Z)-endoxifen, through various phase 2 clinical trials. For instance, the Karisma-Endoxifen study is currently evaluating the ability of (Z)-endoxifen to decrease mammographic breast density in premenopausal women. Results from this significant trial are anticipated before the end of the year.
Supporting Groundbreaking Research
Additionally, Atossa is involved in the SMART (Stockholm MAmmography Risk stratified Trial), which aims to validate an innovative breast cancer risk assessment model powered by artificial intelligence. This study seeks to create an individualized imaging-based screening process tailored to identify women at the highest risk of developing breast cancer. If found effective, it could form the basis for future phase 3 trials exploring the utility of (Z)-endoxifen in breast cancer prevention.
Understanding (Z)-Endoxifen
(Z)-endoxifen stands out as a potent Selective Estrogen Receptor Modulator (SERM) known for its efficacy in estrogen receptor inhibition. It not only combats tumor resistance to hormonal therapies but also targets PKC?1, an oncogenic protein, all while maintaining minimal endometrial proliferative effects compared to traditional treatments like tamoxifen. Importantly, Atossa is formulating a unique oral version of (Z)-endoxifen that avoids the necessity for liver metabolism, enhancing its therapeutic efficacy.
Clinical Trials and Future Prospects
Currently, (Z)-endoxifen is being evaluated in five distinct phase 2 clinical trials, assessing its effects in women across various stages of breast cancer. With four U.S. patents granted and additional applications pending, Atossa is diligently working to establish (Z)-endoxifen as a groundbreaking agent in treating and preventing breast cancer.
More About Atossa Therapeutics
Atossa Therapeutics, Inc. is at the forefront of developing transformative therapies for women facing breast cancer. The commitment to improving patient outcomes is reflected in the innovative approaches being undertaken with (Z)-endoxifen. To learn more about Atossa and its pioneering research, please reach out through the contact details provided below.
Contact Information
Michael Parks, VP Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
Frequently Asked Questions
What does the new FDA rule require?
The FDA rule mandates that mammography facilities inform patients about their breast density in clear, patient-friendly language.
Why is breast density important?
Breast density is a known risk factor for breast cancer and can obscure tumor detection during mammographic screenings.
How is Atossa Therapeutics involved?
Atossa Therapeutics supports the new regulation and is actively researching treatments like (Z)-endoxifen to enhance breast cancer detection and prevention.
What is (Z)-endoxifen?
(Z)-endoxifen is a potent medication being developed by Atossa for the treatment of breast cancer, particularly for women with dense breast tissue.
What future studies is Atossa conducting?
Atossa is involved in ongoing phase 2 clinical trials for (Z)-endoxifen, including studies to evaluate its effectiveness in reducing breast density and preventing breast cancer.
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