Atossa Therapeutics, Inc. Files for Swedish Regulatory Approval to Initiate a Phase 2 Study of Oral Endoxifen to Reduce Mamm...
March 02 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, today announced that it has filed with the
Swedish Medical Product Agency and the Institutional Review Board
to initiate a Phase 2 study of its 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. Studies conducted by others have shown that MBD increases
the risk of developing breast cancer, and reducing MBD can reduce
the incidence of breast cancer.
“This is an important milestone in the development of our oral
Endoxifen product. Regulatory approval is necessary to commence the
Phase 2 randomized, double-blinded, placebo-controlled study in
Stockholm, which will include approximately 1,000 pre-menopausal
women with MBD who will receive daily doses of Endoxifen or placebo
for six months. We expect the Medical Product Authority will
respond within 30 days and that the IRB approval will follow in the
second quarter,” commented Steven Quay, M.D., Ph.D., Atossa’s
Chairman and CEO.
Atossa has established both primary and secondary sources of
manufacturing for the clinical supply of its oral Endoxifen
capsules. With over three years of experience manufacturing
and supplying the oral Endoxifen capsules for its completed
clinical studies, Atossa believes adequate drug supply will be
available to support this Phase 2 study.
The primary objective of the study is to determine if breast
density changes compared to placebo and among different doses, with
secondary endpoints to assess and characterize safety and
tolerability. South General Hospital in Stockholm will be
conducting this study at multiple sites, after having recently
completed the company’s Phase 2 study of its topical form of
Endoxifen. 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 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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