Atossa Therapeutics Announces Full Enrollment of Phase 2 Karisma-Endoxifen Clinical Trial
21 November 2023 - 12:30AM
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 it has reached full enrollment
in the Company’s Karisma-Endoxifen clinical trial, the 240-person
Phase 2 study investigating (Z)-endoxifen in premenopausal women
with measurable mammographic breast density (MBD). Participants
have been randomized to placebo, 1 mg, and 2 mg daily doses of
(Z)-endoxifen and will be treated for six months, over the course
of which mammograms are conducted to measure reduction in MBD. MBD
change is used as a proxy for therapy response.
“Many of the risk factors for breast cancer, including breast
density, are known, which means treating at-risk patient
populations before the disease develops could significantly lower
incidence rates,” said Dr. Per Hall, Professor of Epidemiology at
the Department of Medical Epidemiology and Biostatistics at
Karolinska Institutet, Stockholm, Sweden, and Principal
Investigator of the Karisma-Endoxifen study. “I expect the medical
community and government entities to increase their focus on breast
cancer prevention, which should expedite the development and
availability of novel treatments like (Z)-endoxifen.”
Between 40% and 50% of all women are estimated to have
mammographically dense breasts, which makes mammography less
sensitive and mammograms more difficult to interpret, since cancer
and dense breast tissue both appear white on a mammogram. In women
with the highest density, approximately 50% of all breast cancers
are missed on a mammogram and diagnosed in the interval between two
screening rounds. Because of this, interval cancers are often
larger, more advanced, and more difficult to treat. Women with the
highest density are also four to six times more likely to develop
breast cancer in their lifetime compared to women with the least
dense breasts.
“We are excited that the Karisma-Endoxifen study is fully
enrolled and look forward to seeing data from the trial in the
second half of 2024,” said Dr. Steven Quay, Atossa’s President and
Chief Executive Officer. “While significant progress has been made
in breast cancer treatment, the same cannot be said about breast
cancer prevention, particularly in high-risk women. (Z)-endoxifen
is currently being studied in two populations that are at high risk
of developing breast cancer, women with elevated breast density and
women with ductal carcinoma in situ. Both diagnoses are strong,
independent predictors of breast cancer risk that we feel are
modifiable with (Z)-endoxifen.”
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.
(Z)-endoxifen is currently being studied in four Phase 2 trials:
one in healthy women with measurable breast density, one in women
diagnosed with ductal carcinoma in situ, 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
ContactEric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTSThis press release
contains certain information that may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. We may identify these forward-looking
statements by the use of words such as “expect,” “potential,”
“continue,” “may,” “will,” “should,” “could,” “would,” “seek,”
“intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or
other comparable words. Forward-looking statements in this press
release are subject to risks and uncertainties that may cause
actual results, outcomes, or the timing of actual results or
outcomes, to differ materially from those projected or anticipated,
including risks and uncertainties associated with: macroeconomic
conditions and increasing geopolitical instability; the expected
timing of releasing data; any variation between interim and final
clinical results; actions and inactions by the FDA and foreign
regulatory bodies; the outcome or timing of regulatory approvals
needed by Atossa, including those needed to continue our planned
(Z)-endoxifen trials; our ability to satisfy regulatory
requirements; our ability to regain compliance with the continued
listing requirements of the Nasdaq Stock Market; our ability to
successfully develop and commercialize new therapeutics; the
success, costs and timing of our development activities, including
our ability to successfully initiate or complete our clinical
trials, including our (Z)-endoxifen trials; our anticipated rate of
patient enrollment; our ability to contract with third-parties and
their ability to perform adequately; our estimates on the size and
characteristics of our potential markets; our ability to
successfully defend litigation and other similar complaints and to
establish and maintain intellectual property rights covering our
products; whether we can successfully complete our clinical trial
of oral (Z)-endoxifen in women with mammographic breast density and
our trials of (Z)-endoxifen in women with breast cancer, and
whether the studies will meet their objectives; our expectations as
to future financial performance, expense levels and capital
sources, including our ability to raise capital; our ability to
attract and retain key personnel; our anticipated working capital
needs and expectations around the sufficiency of our cash reserves;
and other risks and uncertainties detailed from time to time in
Atossa’s filings with the Securities and Exchange Commission,
including without limitation its Annual Reports on Form 10-K and
Quarterly Reports on 10-Q. Forward-looking statements are presented
as of the date of this press release. Except as required by law, we
do not intend to update any forward-looking statements, whether as
a result of new information, future events or circumstances or
otherwise.
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