SEATTLE, March 13, 2020 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced today that it will meet with the U.S. FDA on April 30, 2020. The objective of this meeting is to discuss the clinical development of oral Endoxifen to reduce mammographic breast density (MBD).
“This important meeting with the FDA is a critical step in developing our oral Endoxifen for the U.S. market,” commented Janet R. Rea, SVP Regulatory, Quality and Clinical Affairs. “We expect a fruitful discussion that will help us shape our development program in the United States.”
MBD is an emerging public health issue affecting over 10 million women in the U.S. MBD is a recognized risk factor for future breast cancer and there is no approved therapy to reduce MBD. High risk women are usually advised to have more frequent or sophisticated mammograms and to make life-style changes. As envisioned, a short course of oral Endoxifen may provide another option for women with high MBD.
Atossa’s offices are located in Seattle, Washington and ongoing or planned clinical trials of Atossa’s Endoxifen are located in Australia and Sweden. Despite the well-publicized impacts of the current COVID-19 outbreak, Atossa’s operations, including clinical studies and the supply of Endoxifen, have not been negatively impacted. Sufficient quantities of the active pharmaceutical ingredient, Endoxifen, for the currently ongoing and planned clinical trials have been previously manufactured and are in secure storage. Management instituted a temporary policy of working from home, which has been in place since February 26, 2020, and of limited business travel. These policies remain in effect as of today. Finally, the Company has not been notified of any employee illness, as would be required by policy.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossatherapeutics.com.
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 the risks and uncertainties associated with any variation between preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development 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.
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