Atossa Therapeutics Begins Enrollment of Phase 2 Clinical Study of Oral Endoxifen in Sweden
December 22 2021 - 9:30AM
Atossa Therapeutics, Inc. (Nasdaq:ATOS), a clinical stage
biopharmaceutical company seeking to 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 announces that it has initiated enrollment of its
Phase 2 clinical study of oral Z-Endoxifen in Sweden. Participants
in the study will be premenopausal women with elevated mammographic
breast density, which is an emerging public health issue affecting
more than 10 million women in the United States and many more
worldwide.
“This is an extremely important milestone as it marks the next
phase of developing our proprietary Z-Endoxifen,” said Steven Quay,
M.D., Ph.D., Atossa’s Chairman and CEO. “This study will help
determine the relationship between daily doses of Endoxifen and
reduction in breast density and will help us further assess safety
and tolerability. We look forward to providing progress updates as
they become available.”
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 measurable breast density. The primary objective of the
study is to determine the dose-response relationship of daily oral
Z-Endoxifen on breast density reduction. Secondary endpoints will
assess safety and tolerability, and the trial includes an
exploratory endpoint to assess durability of the breast density
changes. It will be conducted at the South General Hospital in
Stockholm, and will include approximately 240 participants who will
receive daily doses of oral Z-Endoxifen or placebo for six months.
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 an active metabolite of an FDA-approved drug called
tamoxifen, which has been widely used for over 40 years to both
treat and prevent breast cancer. Tamoxifen is a “pro-drug”, in that
it must be metabolized into active components (“metabolites”) in
order to be effective. Despite the success of tamoxifen in treating
estrogen-receptor-positive breast cancer, its systemic side effects
have led to generally low acceptance as a therapy to reduce the
risk of breast cancer. We estimate that approximately ten million
women in the U.S. have mammographic breast density (MBD), for which
there is no FDA-approved treatment. Studies conducted by others
have shown that MBD reduces the ability of mammograms to detect
cancer and increases the risk of developing breast cancer. Although
oral tamoxifen is approved to prevent breast cancer in “high-risk”
women (typically based on responses to a questionnaire), it is used
by less than 5% of women with an increased risk of developing
breast cancer because of the actual or perceived side effects and
risks of tamoxifen. We believe our Endoxifen may provide an option
for women to proactively reduce the density of their breasts and
may improve mammography accuracy and patient care by unmasking
cancerous tumors that are otherwise hidden by breast density.
Regulators may not approve Endoxifen to reduce MBD unless we can
demonstrate the relationship between Endoxifen-induced reduction in
MBD and reduction in incidence of breast cancer.
Legislation that has been enacted in almost all U.S. states
requiring that women be notified if they have MBD. These
notifications typically state that women with MBD have a higher
risk of developing breast cancer, and that mammography may not be
as effective in detecting breast cancer because the MBD can “mask”
the detection of cancers.
Atossa has been developing its proprietary Z-Endoxifen for
breast cancer and other breast conditions and has successfully
completed three Phase 1 clinical studies (including a study in men)
and two Phase 2 clinical studies. Atossa has also completed
significant pre-clinical development and has developed clinical
manufacturing capabilities through qualified third parties.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical
company seeking to 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 breast density
or 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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