Atossa Therapeutics Receives Approval from Health Canada to Conduct Phase 2 EVANGELINE Clinical Trial in Canada
July 20 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 Health Canada has issued a “No
Objection Letter” following the Company’s Clinical Trial
Application for its Phase 2 EVANGELINE study. This means Atossa can
open sites and enroll patients in their Phase 2 EVANGELINE study
throughout Canada.
The ongoing Phase 2 EVANGELINE (Endoxifen Versus exemestANe
GosEreLIn) study 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 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. The study
is expected to enroll approximately 175 patients at sites across
the United States and Canada.
"The authorization of our Clinical Trial Application in Canada
will increase the geographic scope of our enrollment efforts for
EVANGELINE and broaden the network of breast cancer specialists
familiar with (Z)-endoxifen in the neoadjuvant setting,” said Dr.
Steven Quay, Atossa’s President and Chief Executive Officer. "In
the coming weeks, we will have data from the pharmacokinetic run-in
cohort, which is designed to identify the optimal dose for the
treatment arm. Once the dose is confirmed, we expect the pace of
enrollment to increase as we activate additional sites in the
United Sates and Canada.”
About Premenopausal Women with ER+ / HER2- Breast
CancerBreast cancer is the most frequently diagnosed
cancer in premenopausal women worldwide and accounts for almost
half of the cancers that occur in women aged 15-49. An overwhelming
majority (75%) of premenopausal breast cancer falls under luminal A
(ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function
suppression, when combined with either tamoxifen or an aromatase
inhibitor, is the standard of care for the endocrine management of
stage 2 and 3 premenopausal ER+/HER2- breast cancer.
About the Phase 2 EVANGELINE StudyThe Phase 2
EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study 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.
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.
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 the expected timing of releasing data, 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, anticipated progress on Atossa’s (Z)-endoxifen
development program, 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, anticipated working
capital needs and expectations around the sufficiency of our cash
reserves, 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.
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Apr 2024 to May 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From May 2023 to May 2024