Atossa Therapeutics Granted Additional Patent Protection for Endoxifen
June 21 2023 - 10:13AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative proprietary
medicines to address significant unmet needs in oncology with a
focus on breast cancer, today announces that the United States
Patent and Trademark Office (USPTO) has granted a new patent (No.
11,680,036) directed to enterically encapsulated endoxifen
compositions formulated as a suspension. These include all liquid
suspension formulations suitable for oral administration and
dispersible tablets, powders, granules, pellets or sprinkles for
reconstitution, which are commonly used for pediatric
administration. A short video explaining the new patent can be
found here: Suspension Patent Update.
A suspension is a heterogeneous mixture. It differs from a
solution, which is a homogeneous mixture, in that the particles in
a solution are much smaller and are dissolved in a solvent,
therefore staying mixed together. In a suspension, the particles
are large, do not dissolve, and will separate. Advantages of
suspension formulations may include ease of delivery of low soluble
therapeutic agents, increased bioavailability of drug dosage,
controlled drug delivery and resistance to degradation.
“Our new patent covering suspension formulations is important as
we continue to learn more about the potential therapeutic role of
endoxifen beyond breast cancer and mammographic breast density,”
said Dr. Steven Quay, Atossa’s President and Chief Executive
Officer. “Suspension formulations are particularly useful in
pediatric applications where drugs are often dosed by weight and
delivered via powders or sprinkles mixed with food and dispersible
tablets, which are easier for children to ingest compared to
tablets.”
About (Z)-Endoxifen(Z)-endoxifen is the most
active metabolite of the FDA approved Selective Estrogen Receptor
Modulator (SERM), tamoxifen. Studies by others have demonstrated
that the therapeutic effects of tamoxifen are driven in a
concentration-dependent manner by (Z)-endoxifen. In addition to its
potent anti-estrogen effects, (Z)-endoxifen at higher
concentrations has been shown to target PKCβ1, a known oncogenic
protein.
Atossa is developing a proprietary oral formulation of
(Z)-endoxifen that does not require liver metabolism to achieve
therapeutic concentrations and is encapsulated to bypass the
stomach as acidic conditions in the stomach convert a greater
proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s
(Z)-endoxifen has been shown to be well tolerated in Phase 1
studies and in a small Phase 2 study of women with breast cancer.
The Company is currently studying (Z)-endoxifen in three Phase 2
studies: one in healthy women with measurable breast density and
two other studies including the EVANGELINE study in women with
ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by
three issued U.S. patents and numerous pending patent
applications.
About Atossa TherapeuticsAtossa Therapeutics,
Inc. is a clinical-stage biopharmaceutical company developing
innovative medicines in areas of significant unmet medical need in
oncology with a focus on breast cancer. For more information,
please visit www.atossatherapeutics.com
CONTACT:Eric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTSForward-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 (Z)-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 in Ki-67 or
any other result from a neoadjuvant study is an approvable endpoint
for (Z)-endoxifen, whether Atossa can complete acquisitions, 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.
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