Atossa Therapeutics Announces Final Data from Phase 2 Endoxifen Breast Cancer Study Primary Endpoint Met: 65.1% Reduction i...
June 09 2021 - 09:00AM
Atossa Therapeutics, Inc. (Nasdaq:ATOS), a clinical stage
biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical need
with a current focus on breast cancer and COVID-19, today announced
the following final data from its Phase 2 clinical study of oral
Endoxifen administered in the “window of opportunity” between
diagnosis of breast cancer and surgery.
- Primary Endpoint Met: Reduction in Ki-67 was achieved. Ki-67, a
common measure of tumor cell activity, was reduced from an average
of 25.6% at screening to 6% on the day of surgery, a 65.1%
reduction. Ki-67 was reduced below 25% for all patients, which is
potentially clinically meaningful because studies by others have
shown that a reduction below 25% improves long term survival.
- Secondary Endpoints Were as Follows: Safety and tolerability:
All adverse events were mild and considered related to the study
drug. There were no abnormal laboratory findings (serum chemistry,
hematology, coagulation, urinalysis) and no differences in vital
signs, physical examinations and ECGs. Based on these results,
Endoxifen was considered safe and well tolerated in this study. No
adverse events led to discontinuation of the study. Other Results:
Estrogen receptor expression decreased from 100% at screening to
88.6% on the day of surgery and progesterone receptor expression
increased from 84.3% at screening to 92.9% on the day of surgery.
No correlation between Ki-67 expression and Endoxifen levels was
observed.
“Based on these favorable results, we are taking a number of
steps to quickly advance our development of Endoxifen,” commented
Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive
Officer. “We have begun the formal non-clinical toxicology program
that will be needed for a New Drug Application to seek marketing
approval for Endoxifen and plan to apply to the U.S. FDA for
approval to conduct a clinical study here in the United States as
soon as possible. We expect the next clinical study to measure
pathological complete response in the neoadjuvant setting. Although
there are several FDA-approved neoadjuvant therapies for breast
cancers that are not estrogen receptor positive (ER+), currently
there are very few approved therapies for the approximately 78% of
breast cancers, which are ER+ that we believe creates a significant
unmet need for our Endoxifen.”
Atossa will hold a webinar at 8:00 am Pacific Time today to
discuss the study results. To register to join the
complimentary ZOOM-based webinar event, please visit Tribe Public
LLC at ATOS.TribePublic.com. Registered participants may email
questions for Atossa’s management to Tribe Public prior to the
event at research@tribepublic.com or share their
questions via the ZOOM chat feature during the event. Tribe
Public’s Managing Member, John F. Heerdink, Jr., will host the
event and relay questions to management.
The study enrolled seven newly-diagnosed patients with ER+ and
human epidermal growth factor receptor 2 negative (HER2-) stage 1
or 2 invasive breast cancer, requiring mastectomy or lumpectomy.
Patients received the Atossa proprietary oral Endoxifen for at
least 14 days from the time of diagnosis up to the day of surgery.
The primary endpoint was to determine if the administration of oral
Endoxifen reduces the tumor activity as measured by Ki-67. The
secondary endpoints were safety and tolerability and assessment of
the study drug on expression levels of both estrogen and
progesterone receptors, and correlation between Ki-67 and Endoxifen
levels. The Phase 2 study was conducted on behalf of Atossa by
Avance Clinical, a leading Australian CRO.
The American Cancer Society (ACS) estimates that in 2021,
281,550 women will be diagnosed with breast cancer in the
U.S. and 43,600 will die. ER+ breast cancer makes up
approximately 78% of all women diagnosed with breast cancer.
Atossa is evaluating a number of potential clinical benefits and
potential indications for its oral Endoxifen in the window of
opportunity, or neoadjuvant, setting. These may include avoidance
of surgery in some patients, such as older and/or frail patients,
allowing for breast conservation surgery, and use of Endoxifen in
place of other neoadjuvant therapies such as chemotherapy,
aromatase inhibitors and other endocrine therapies like
tamoxifen.
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 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
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Feb 2024 to Mar 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Mar 2023 to Mar 2024