Atossa Therapeutics Receives Approval from the Swedish Ethics Review Authority to Initiate a Phase 2 Clinical Study of Oral Endoxifen to Reduce Mammographic Breast Density in Sweden

SEATTLE, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq:ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today announced it has received approval from the Swedish Ethics Review Authority to begin a Phase 2 clinical study of oral Endoxifen for the reduction of mammographic breast density (MBD). MBD is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide. Studies conducted by others have shown that MBD reduces the ability of mammograms to detect cancer and increases the risk of developing breast cancer. Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.

“With this ethics approval and the previously reported regulatory approval to conduct the clinical study, we plan to start enrolling participants in fourth quarter 2021,” said Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO. “We are excited to be working with Dr. Per Hall, a world leader in the field of breast density reduction, once again with our Endoxifen program.”

The study, known as the Karisma-Endoxifen study, is a Phase 2, randomized, double-blind, placebo-controlled, dose-response study of Atossa’s proprietary oral Z-Endoxifen in healthy premenopausal women with increased breast density. The primary objective of the study is to determine the dose-response relationship of daily oral Endoxifen on MBD reduction, with secondary endpoints to assess safety, and tolerability, and an exploratory endpoint to assess durability of the MBD changes. It will be conducted in Stockholm and will include approximately 240 participants who will receive daily doses of oral Endoxifen or placebo for six months. South General Hospital in Stockholm will be conducting the study. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

About Atossa's Proprietary Endoxifen

Endoxifen is the most active metabolite of tamoxifen, which is an FDA-approved drug to treat breast cancer. Tamoxifen itself must be broken down by the liver into active compounds (metabolites). In third party preclinical studies, endocrine-sensitive and letrozole-resistant breast tumors, Z-endoxifen resulted in robust antitumor and antiestrogenic activity compared to tamoxifen and aromatase inhibitor monotherapy.

Atossa has been developing its proprietary oral Endoxifen for breast cancer and other breast conditions and has successfully completed four clinical studies with oral Endoxifen. In addition, our proprietary Endoxifen has been used in two expanded access studies, one of a female breast cancer patient, and the other in an ovarian cancer patient.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

Forward-Looking Statements Disclaimer Statement

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse, CFO and General Counsel
Office: 866 893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Core IR
Office:(516) 222-2560
ir@atossainc.com


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