Atossa Doses First Patient in Phase 2 Neoadjuvant Clinical Study of (Z)-Endoxifen in Premenopausal Women with ER+/HER2- Breast Cancer
February 23 2023 - 9:15AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative proprietary
medicines to address significant unmet need in cancer, today
announces that the first patient has been dosed in the Phase 2
EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study.
EVANGELINE is a randomized non-inferiority trial of Atossa’s
patented Selective Estrogen Receptor Modulator (SERM),
(Z)-endoxifen, and exemestane plus goserelin as a neoadjuvant
treatment for pre-menopausal women with Grade 1 or 2 Estrogen
Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2
negative (HER2-) breast cancer. Participants will receive
neoadjuvant treatment for up to six months, followed by surgery.
The study is expected to enroll approximately 175 patients at up to
25 sites across the United States.
The primary objective of the EVANGELINE study is to evaluate the
endocrine sensitive disease (ESD) rate, measured by Ki-67 (a
proliferation marker prognostic for disease free survival), after
four weeks of treatment with (Z)-endoxifen compared to treatment
with current standard of care, exemestane plus goserelin.
Exemestane is an aromatase inhibitor designed to block the
synthesis of estrogen and slow the growth of ER+ cancers. Goserelin
is a medication given to block the ovaries from making estrogen,
also called ovarian function suppression (OFS). In premenopausal
women, OFS is associated with significant morbidity and inadequate
compliance, which compromises efficacy and increases the risk of
mortality.
(Z)-endoxifen is the most active anti-estrogen metabolite of
tamoxifen that potently blocks ERa and binds to and disrupts
protein kinase C beta one function (PKCb1, a known oncogenic
protein). In an earlier Phase 2 study, treatment with (Z)-endoxifen
resulted in a 65.1% reduction in Ki-67. This is potentially
clinically meaningful because numerous studies by other groups have
shown that reducing Ki-67 is prognostic for 5-year disease free
survival. (Z)-endoxifen administered as monotherapy may also
obviate the need for OFS in premenopausal women and potentially
reduce breast cancer cell proliferation.
“We are excited to kick-off this important trial, a significant
achievement in our development strategy,” said Dr. Steven Quay,
Atossa’s President and Chief Executive Officer. “Approximately 78%
of breast cancers are ER+ / HER2- and premenopausal women diagnosed
with this disease need more effective and tolerable treatment
options; specifically new treatments that do not require ovarian
function suppression. We feel (Z)-endoxifen has the potential to
change the treatment paradigm for these patients.”
Atossa is also developing its proprietary (Z)-endoxifen to
reduce breast density, a known risk factor for developing breast
cancer. The Company has an ongoing Phase 2 trial focused on
reducing mammographic breast density (MBD) in healthy,
premenopausal women. Known as the “Karisma-Endoxifen” study, this
randomized, double-blind, placebo-controlled trial plans to enroll
240 study participants. Participants receive daily doses of
(Z)-endoxifen for six months, over the course of which mammograms
are conducted to measure reduction in MBD. Participants also have a
mammogram at 24 months to assess the durability of the MBD
changes.
MBD affects more than 10 million women in the United States and
many millions more worldwide. Increased MBD reduces the ability of
mammograms to detect cancer. Studies have also shown that women
with MBD have an increased risk of developing breast cancer and
that the higher the MBD, the higher the incidence of breast
cancer.
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 anti-estrogenic 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 has developed 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 converts 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. We are currently
studying our (Z)-endoxifen in healthy women with measurable breast
density and premenopausal women with ER+/HER2- breast cancer.
Atossa’s (Z)-endoxifen is protected by two 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 current focus on breast cancer and lung injury
caused by cancer treatments. For more information, please visit
www.atossatherapeutics.com
CONTACTS:Kyle GuseGeneral Counsel and Chief
Financial Officerkyle.guse@atossainc.com
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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