SEATTLE, December 22, 2021 (GLOBE NEWSWIRE) – Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative drugs in areas with significant medical needs in oncology and infectious diseases with a current focus on breast cancer and covid -19, announces today that it has begun registration of its clinical phase 2 study of oral Z-Endoxifen in Sweden. Participants in the study will be premenopausal women with elevated mammographic breast density, which is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide.

“This is an extremely important milestone as it marks the next phase in the development of our patented Z-Endoxifen,” said Steven Quay, MD, Ph.D., Atossa’s Chairman and CEO. “This study will help us establish the relationship between daily doses of Endoxifen and reduction in breast density and will help us further assess safety and tolerability. We look forward to providing progress updates as they become available.”

The study, known as the Charisma-Endoxifen Study, is a Phase 2, randomized, double-blind, placebo-controlled, dose-response study of Atossa’s patented oral Z-Endoxifen in healthy premenopausal women with measurable breast density. The primary purpose of this study is to determine the dose-response relationship of daily oral Z-Endoxifen to breast density reduction. Secondary endpoints will assess safety and tolerability, and the trial will include an exploratory endpoint to assess the sustainability of changes in breast density. It will be carried out at Södra Allmänna Hospital in Stockholm and will include about 240 participants who will receive daily doses of oral Z-Endoxifen or placebo for six months. The study is led by lead researcher Per Hall, MD, Ph.D., head of the department of medical epidemiology and biostatistics at Karolinska Institutet.

About Atossa’s Proprietary Endoxifene

Endoxifen is an active metabolite of an FDA-approved drug called tamoxifen, which has been widely used for over 40 years to both treat and prevent breast cancer. Tamoxifen is a “pro-drug”, in that it must be metabolized to active components (“metabolites”) in order to be effective. Despite the success of tamoxifen in the treatment of estrogen receptor positive breast cancer, its systemic side effects have led to generally low acceptance as a therapy to reduce the risk of breast cancer.

We estimate that approximately ten million women in the United States have mammographic breast density (MBD), for which there is no FDA-approved treatment. Studies by others have shown that MBD reduces the ability of mammography to detect cancer and increases the risk of developing breast cancer. Although oral tamoxifen is approved for the prevention of breast cancer in “high-risk” women (usually based on a questionnaire response), it is used by less than 5% of women at increased risk of developing breast cancer due to the actual or perceived side effects. and risks with tamoxifen. We believe that our Endoxifen may be an alternative for women to proactively reduce the density of their breasts and may improve mammography accuracy and patient care by detecting cancerous tumors that are otherwise obscured by breast density. Regulators may not approve Endoxifen to reduce MBD if we can not demonstrate the link between Endoxifen-induced reduction in MBD and reduction in the incidence of breast cancer.

Legislation that has been passed in almost every U.S. state that requires women to be notified if they have an MBD. These messages usually indicate that women with MBD have a higher risk of developing breast cancer and that mammography may not be as effective in detecting breast cancer because MBD can “mask” the detection of cancer.

Atossa has developed its patent-protected Z-Endoxifen for breast cancer and other breast conditions and has successfully completed three Phase 1 clinical trials (including one in men) and two Phase 2 clinical trials. Atossa has also implemented significant pre-clinical development and has developed clinical manufacturing capacity through qualified third parties.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-phase biopharmaceutical company that wants to develop innovative drugs in areas with significant medical needs in oncology and infectious diseases with a current focus on breast cancer and covid-19. For more information, visit www.atossatherapeutics.com.

Forward-looking statements Disclaimer

Forward-looking statements in this press release, which Atossa does not undertake to update, are subject to risks and uncertainties that may cause actual results to differ materially from the expected or estimated future results, including, without limitation, statements of satisfaction of closing conditions related to the offer and the expected use of the proceeds of the offer, the risks and uncertainties associated with any variations between interim and final clinical results, actions and omissions by the FDA, the result or timing of regulatory approvals required by Atossa including those required to begin studies on AT-H201 , AT-301 and Endoxifen, lower than expected patient enrollment rates, estimated market size for drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, barriers arising from patent rights as in nnehas by others such as patent rights, whether reduction in breast density or Ki-67 or any other result from a neoadjuvant study is an approved measure of oral endoxifen and other risks described from time to time in Atossa’s notifications to the Securities and Exchange Commission, including without limiting its periodic reports on Form 10 -K and 10-Q, each with changes and additions from time to time.

Company contact:
Atossa Therapeutics, Inc.
Kyle Guse, CFO and General Counsel
Office: 866 893-4927
[email protected]

Contact for investor relations:
Core IR
Office: (516) 222-2560
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