Atossa Therapeutics Announces Issuance of Key U.S. Patent Covering Endoxifen
March 08 2022 - 9:15AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to develop innovative medicines
in oncology and infectious disease with a current focus on breast
cancer and COVID-19, today announces that the U.S. Patent and
Trademark office has issued a new patent further strengthening
Atossa’s intellectual property in its proprietary therapy
Endoxifen, which is under development for breast cancer and other
breast conditions.
U.S. Patent No. 11,261,151 (the ‘151 Patent) is
titled “Methods for Making and Using Endoxifen” and is directed to
compositions of storage-stable Endoxifen and methods of treating
hormone-dependent breast disorders using the storage-stable
Endoxifen.
“We are very pleased with the scope and breadth of this new key
patent,” said Dr. Steven Quay, Atossa’s President and Chief
Executive Officer. “Patents covering the composition of matter of
new therapies are critical to protect markets from generic
competition. The ‘151 Patent,’ with its estimated expiration in
2038, strengthens our intellectual property estate and should
create long-term stockholder value.”
Atossa is developing its proprietary Endoxifen in two clinical
settings: one to reduce tumor cell activity in breast cancer
patients in the neoadjuvant setting, meaning prior to surgery; and
another to reduce dense breast tissue in women. A Phase 2
study is currently underway in women with measurable breast density
and Atossa plans to submit a request (IND) to the FDA to open other
Phase 2 in the neoadjuvant setting in the next quarter.
Atossa’s neoadjuvant program is focused on breast cancers that
are classified as estrogen receptor positive (ER+). Although there
are numerous neoadjuvant treatments for breast cancers that are not
ER+, there are few neoadjuvant treatments for ER+ breast cancer
which comprises about 78% of all breast cancers. We believe there
is a compelling need for therapy with our Endoxifen in this
setting.
An estimated ten million women in the U.S. have mammographic
breast density, or MBD, for which there is no FDA-approved
treatment. MBD is an emerging public health issue and studies
conducted by others have shown that MBD increases the risk of
developing breast cancer and that reducing MBD can reduce the
incidence of breast cancer. The American Cancer Society estimates
that in the U.S. in 2022, 287,850 women will be diagnosed
with breast cancer, 47,550 of which will be under the age of 50 and
43,250 of which will die from the disease.
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 estimated patent lives, 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 and continue
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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