Atossa Therapeutics Announces Upcoming Meeting with FDA
March 13 2020 - 8:30AM
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
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.
Atossa Therapeutics Company Contact:
Atossa Therapeutics, Inc.Kyle GuseCFO and General Counsel(O)
800-351-3902kyle.guse@atossainc.com
Investor Relations Contact:
Scott GordonCoreIR377 Oak StreetConcourse 2Garden City, NY
11530Office: 516.222.2560scottg@CoreIR.com
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