Atossa Therapeutics Receives Approval from Swedish Regulators to Initiate Phase 2 Clinical Study of Oral Endoxifen to Reduce ...
June 11 2021 - 9:00AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to discover and develop
innovative medicines in oncology and infectious disease with a
current focus on breast cancer and COVID-19, announces that it has
received approval from the Swedish Medical Product Agency (MPA) to
initiate a Phase 2 clinical 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 and many more worldwide. Studies conducted by others
have shown that MBD reduces the ability of mammograms to detect
cancer (sensitivity) 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.
“This is a critical milestone in the development of our oral
Endoxifen,” commented Steven Quay, M.D., Ph.D., Atossa’s Chairman
and CEO. “We now plan to commence the study as soon as restrictions
for COVID-19 in Stockholm allow and we are encouraged that daily
and weekly average COVID-19 cases have been steadily declining in
Sweden over the past six weeks. If this trend continues, we expect
to initiate the study in the next quarter. We have also received
useful input from the MPA about the development path for Endoxifen.
Based in part on that input we will consider conducting future
studies to measure the treatment effect of Endoxifen not only on
MBD reduction but also on the reduction of the incidence of breast
cancer. In addition to clinical data, regulators will require that
we also develop preclinical information including toxicology
studies and information about manufacturing oral Endoxifen prior to
regulatory approval. We have now established two manufacturing
sources of Endoxifen for clinical and potential future commercial
use and we have initiated a significant portion of the preclinical
studies needed for a New Drug Application.”
The primary objective of the MBD study is to determine the
dose-response relationship of daily oral Endoxifen on mammographic
breast density reduction, with secondary endpoints assessing safety
and tolerability. The Phase 2 study will be randomized,
double-blinded and placebo-controlled. It will be conducted in
Stockholm and will include approximately 240 pre-menopausal women
with measurable MBD 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.
The study is also subject to approval by the institutional ethics
committees and enrollment will not begin unless and until all
approvals are obtained and COVID restrictions are lifted in
Sweden.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical
company seeking to discover and develop innovative medicines 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
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
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
Source: Atossa Therapeutics, Inc.
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