Atossa Therapeutics Announces First Patient Dosing of (Z)-Endoxifen in the Ongoing RECAST DCIS Study
February 22 2024 - 8:30AM
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 announced that the first patient has
been dosed with Atossa’s proprietary Selective Estrogen Receptor
Modulator (SERM), (Z)-endoxifen, in the Re-Evaluating Conditions
for Active Surveillance Suitability as Treatment: Ductal Carcinoma
In Situ (RECAST DCIS) study. RECAST DCIS is an ongoing Phase 2
platform study designed to offer women diagnosed with DCIS six
months of neoadjuvant endocrine therapy with the intent of
determining their suitability for long-term active surveillance
without surgery.
A short 'explainer' video about Ductal Carcinoma In Situ and the
RECAST DCIS study can be found here: DCIS Video Explainer.
“Ductal Carcinoma In Situ is pre-invasive cancer, but the
current standard of care is to treat it like early-stage invasive
breast cancer, which for most patients involves surgery, followed
by radiation treatment for three to four weeks and finally hormone
therapy for five years,” Dr. Steven Quay, Atossa’s President and
Chief Executive Officer. “This is an overly aggressive treatment
approach, especially when you consider most DCIS cases will not
progress to invasive breast cancer if left untreated. We feel
treatment with (Z)-endoxifen has the potential to replace the
current standard of care, which would spare a significant
percentage of patients diagnosed with DCIS from undergoing
aggressive, invasive, unnecessary treatment.”
The RECAST DCIS trial is sponsored and operated by Quantum Leap
Healthcare Collaborative, which was established in 2005 as a
collaboration between medical researchers at University of
California, San Francisco and Silicon Valley entrepreneurs.
Participants in the study will be treated with up to six months of
endocrine therapy with the intent to forego surgery and instead be
monitored via long-term active surveillance. A key element in
reducing overtreatment of DCIS is identifying biomarkers that
reflect the risk of progression so that those with low-risk lesions
are spared surgery. RECAST DCIS features the assessment of imaging
and molecular-based biomarkers in addition to evaluating new
investigational agents in this setting. The (Z)-endoxifen study arm
is expected to enroll up to 110 patients.
About Ductal Carcinoma In SituDuctal Carcinoma
In Situ (DCIS) is considered the earliest form of breast cancer.
DCIS is usually found during a mammogram done as part of breast
cancer screening or to investigate a breast lump. It is
noninvasive, meaning it hasn't spread out of the milk duct, and has
a low risk of becoming invasive. Current standard of care includes
surgery, radiation therapy, and/or hormone therapy. Approximately
60,000 DCIS diagnoses are made each year in the United States
alone. Studies show that recurrence of DCIS can occur in up to 1 in
3 patients following treatment.
About (Z)-Endoxifen(Z)-endoxifen is the most
active metabolite of the FDA approved Selective Estrogen Receptor
Modulator (SERM), tamoxifen. Studies 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. (Z)-endoxifen also appears to deliver similar or even
greater bone agonistic effects while resulting in little or no
endometrial proliferative effects compared with tamoxifen.
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 Quantum Leap Healthcare
CollaborativeQuantum Leap Healthcare Collaborative is a
501c(3) charitable organization established in 2005 as a
collaboration between medical researchers at University of
California, San Francisco and Silicon Valley entrepreneurs. Our
mission is to integrate care and research, and to foster
high-impact trials with embedded clinical processes and systems
technology and improved data management, greater access to clinical
trial matching, and greater benefit to patients, providers, and
researchers. Our goal is to improve and save lives. Quantum Leap
provides operational, financial, and regulatory oversight to I-SPY.
For more information, visit https://www.quantumleaphealth.org/
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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