Atossa Therapeutics Announces Two-Year Update of FDA-Approved Expanded Access Treatment with Endoxifen

Rhea-AI Summary

Atossa Therapeutics (Nasdaq: ATOS) reported promising results from a 26-month Expanded Access study involving its oral Endoxifen for a breast cancer patient. The patient has not experienced a recurrence of cancer, nor any adverse treatment-related effects, and has tolerated the drug well compared to tamoxifen. FDA authorization allowed the use of Endoxifen before and after surgery, marking a significant step in its development. The CEO noted the patient's experience as a model for future drug development efforts in addressing unmet medical needs.

Positive

• No recurrence of breast cancer reported after 26 months of Endoxifen treatment.
• Patient experienced no treatment-related side effects, unlike those associated with tamoxifen.
• FDA authorization for both pre- and post-surgery administration supports ongoing development.

Negative

• None.

SEATTLE, Feb. 03, 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 with a current focus on breast cancer and COVID-19, announces updated findings following 26 months of Expanded Access (or “compassionate use”) single-patient studies of Atossa’s Endoxifen.

“To date, the patient has not had a recurrence of breast cancer, as assessed by clinical breast examination and mammography; has not had treatment-related changes in periodic laboratory blood tests and general clinical examinations; and, the treatment has been well tolerated, including an absence of typical vasomotor symptoms commonly associated with tamoxifen (for example, night sweats and hot flashes), an FDA-approved drug frequently prescribed for breast cancer treatment,” commented Sidney Goldblatt, M.D., Principal Investigator.

At the end of 2018, the FDA authorized a single-patient study under its Expanded Access, or compassionate use program, for this breast cancer patient to receive Atossa’s oral Endoxifen in the “window of opportunity” between diagnosis of breast cancer and surgery. Following surgery, an additional compassionate use authorization was granted by the FDA for the same patient, who has now continued to take oral Endoxifen in the adjuvant setting following her surgery. She has now taken Atossa’s oral Endoxifen for approximately 26 months and is continuing to take oral Endoxifen daily under these authorizations.

“This patient, like many breast cancer patients, was reluctant to take tamoxifen because of the well-documented side effects associated with that drug and because she lacked the proper liver enzymes to properly metabolize tamoxifen,” commented Steve Quay, Ph.D., M.D., Atossa’s President and CEO. “We are very encouraged by this patient’s experience with our Endoxifen over the past two years. Her experience serves as a model for ongoing development efforts.”

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 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

FAQ

What are the latest findings from Atossa Therapeutics regarding Endoxifen?

Atossa Therapeutics reported that a breast cancer patient has not had a recurrence of cancer after 26 months of taking Endoxifen.

How has the patient tolerated Endoxifen compared to tamoxifen?

The patient has tolerated Endoxifen well, without the typical side effects commonly associated with tamoxifen.

What regulatory approval did Atossa receive for Endoxifen treatments?

The FDA granted authorization for expanded access to use Endoxifen in a single-patient study before and after surgery.

What is the significance of the patient's experience with Endoxifen for Atossa?

The patient's positive experience with Endoxifen serves as a model for future development efforts by Atossa.