Atossa Therapeutics Provides Enrollment Update for Ongoing Phase 2 Karisma-Endoxifen Clinical Trial
July 10 2023 - 9:15AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative medicines in areas
of significant unmet medical need in oncology with a focus on
breast cancer, today announced that 170 patients have been enrolled
in the Company’s ongoing Phase 2 Karisma-Endoxifen clinical trial.
Atossa expects the study to fully enroll in the fourth quarter of
2023.
The Karisma-Endoxifen trial is a randomized,
double-blind, placebo-controlled efficacy study of oral
(Z)-endoxifen in premenopausal women with measurable breast
density. Participants receive daily doses of (Z)-endoxifen for six
months, over the course of which mammograms are conducted to
measure reduction in mammographic breast density (MBD).
Participants will also have a mammogram at 24 months to assess the
durability of the MBD changes.
Between 40% and 50% of all women are estimated to
have mammographically dense breasts, which makes mammography less
sensitive and more difficult to interpret, since cancer and dense
breast tissue both appear white on a mammogram. Because of this,
cancers are often larger, more advanced, and more difficult to
treat when found in women with dense breast tissue. Additionally,
mammographic breast density is a strong, independent predictor of
breast cancer risk. Women with the highest density are four to six
times more likely to get breast cancer than women with the least
dense breasts.
“We are excited about the progress we’ve made in
our mammographic breast density study and look forward to fully
enrolling the trial later this year and seeing data in 2024,” said
Dr. Steven Quay, Atossa’s President and Chief Executive Officer.
“There are currently no approved treatments for women diagnosed
with elevated breast density. We feel (Z)-endoxifen has the
potential to reduce breast density in this patient population,
which would make mammograms more reliable and decrease the risk
that these women will develop cancer in their lifetime.”
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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