Atossa Therapeutics Receives Approval from the Swedish Ethics Review Authority to Initiate a Phase 2 Clinical Study of Oral Endoxifen to Reduce Mammographic Breast Density in Sweden
September 02 2021 - 9:30AM
Atossa Therapeutics, Inc. (Nasdaq:ATOS), a clinical stage
biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical need in
oncology and infectious diseases with a current focus on breast
cancer and COVID-19, today announced it has received approval from
the Swedish Ethics Review Authority to begin a Phase 2 clinical
study of 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 and many more
worldwide. Studies conducted by others have shown that MBD reduces
the ability of mammograms to detect cancer and increases the risk
of developing breast cancer. Additional studies show a correlation
between reducing MBD and a reduction in the incidence of breast
cancer.
“With this ethics approval and the previously reported
regulatory approval to conduct the clinical study, we plan to start
enrolling participants in fourth quarter 2021,” said Steven Quay,
M.D., Ph.D., Atossa’s Chairman and CEO. “We are excited to be
working with Dr. Per Hall, a world leader in the field of breast
density reduction, once again with our Endoxifen program.”
The study, known as the Karisma-Endoxifen study, is a Phase 2,
randomized, double-blind, placebo-controlled, dose-response study
of Atossa’s proprietary oral Z-Endoxifen in healthy premenopausal
women with increased breast density. The primary objective of the
study is to determine the dose-response relationship of daily oral
Endoxifen on MBD reduction, with secondary endpoints to assess
safety, and tolerability, and an exploratory endpoint to assess
durability of the MBD changes. It will be conducted in Stockholm
and will include approximately 240 participants who will receive
daily doses of oral Endoxifen or placebo for six months. South
General Hospital in Stockholm will be conducting the study. 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's Proprietary Endoxifen
Endoxifen is the most active metabolite of tamoxifen, which is
an FDA-approved drug to treat breast cancer. Tamoxifen itself must
be broken down by the liver into active compounds (metabolites). In
third party preclinical studies, endocrine-sensitive and
letrozole-resistant breast tumors, Z-endoxifen resulted in robust
antitumor and antiestrogenic activity compared to tamoxifen and
aromatase inhibitor monotherapy.
Atossa has been developing its proprietary oral Endoxifen for
breast cancer and other breast conditions and has successfully
completed four clinical studies with oral Endoxifen. In addition,
our proprietary Endoxifen has been used in two expanded access
studies, one of a female breast cancer patient, and the other in an
ovarian cancer patient.
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 in oncology and infectious
diseases 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 CounselOffice: 866
893-4927kyle.guse@atossainc.com
Investor Relations
Contact:Core IROffice:(516)
222-2560ir@atossainc.com
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