Atossa Therapeutics Announces Full Enrollment of (Z)-Endoxifen Arm of I-SPY 2 Clinical Trial
February 07 2024 - 8:30AM
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 the (Z)-endoxifen arm of the
ongoing Phase 2 I-SPY 2 clinical trial has fully enrolled. In the
study, (Z)-endoxifen, Atossa’s proprietary Selective Estrogen
Receptor Modulator (SERM), is being evaluated as a neoadjuvant
treatment for newly diagnosed estrogen receptor-positive (ER+)
invasive breast cancer.
“We are excited that the (Z)-endoxifen arm of the I-SPY 2 study
has fully enrolled and look forward to seeing data from this study
in the second half of 2024,” said Steven Quay, MD, PhD, Atossa’s
President and Chief Executive Officer. “Estrogen receptor positive
breast cancer accounts for over 80% of all breast cancer diagnoses
and unfortunately, the current neoadjuvant treatment options for
these patients are sub-optimal. Treatment with (Z)-endoxifen has
the potential to down-stage the tumor, improve tumor resectability
and reduce the incidence of breast cancer recurrence, all while
demonstrating a far superior safety and tolerability profile
compared to aromatase inhibitors and systemic chemotherapy. This
would transform the treatment paradigm for the hundreds of
thousands of women diagnosed with ER-positive breast cancer every
year.”
The I-SPY 2 TRIAL is a collaborative effort among academic
investigators from major cancer research centers across the United
States, Quantum Leap Healthcare Collaborative, the U.S. Food and
Drug Administration, and the Foundation for the National Institutes
of Health (FNIH) Cancer Biomarkers Consortium. The (Z)-endoxifen
treatment arm, which enrolled 20 patients, is part of the I-SPY 2
Endocrine Optimization Pilot Protocol (EOP). Patients receive 10 mg
of (Z)-endoxifen daily for up to 24 weeks prior to surgery.
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
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 the I-SPY TRIALsThe I-SPY TRIAL
(Investigation of Serial studies to Predict Your Therapeutic
Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was
designed to rapidly screen promising experimental treatments and
identify those most effective in specific patient subgroups based
on molecular characteristics (biomarker signatures). The Endocrine
Optimization Pilot (EOP) is developing better endpoints and new
endocrine targeted agents for stage 2/3 molecularly low risk breast
cancer. The trial is a unique collaborative effort by a consortium
that includes the Food and Drug Administration (FDA), industry,
patient advocates, philanthropic sponsors, and clinicians from 30
major U.S. cancer research centers. Under the terms of the
collaboration agreement, Quantum Leap Healthcare Collaborative is
the trial sponsor and manages all study operations. For more
information, visit www.ispytrials.org.
Atossa Therapeutics Contact:Eric 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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