Atossa Completes Enrollment of Pharmacokinetic Run-In Cohort in Phase 2 EVANGELINE Clinical Trial Evaluating (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer
12 June 2023 - 11:15PM
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 announces that the pharmacokinetic
(PK) run-in cohort of the Phase 2 EVANGELINE (Endoxifen Versus
exemestANe GosEreLIn) study has fully enrolled. 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.
The PK run-in cohort consists of six patients, all
of whom will be treated with (Z)-endoxifen at 40mg/day for four
weeks. The goal of the PK run-in cohort is to determine if the 40mg
dose delivers steady-state plasma concentrations (Css) between 500
- 1000 ng/mL, which are optimal to target PKCβ1 inhibition and
enhance (Z)-endoxifen’s antitumor mechanism of action.
Once the optimal dose of (Z)-endoxifen is
determined, the Treatment Cohort will commence. Participants in the
treatment cohort 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.
"We are excited to fully enroll the EVANGELINE PK
run-in cohort and look forward to seeing data in Q3 of this year,”
said Dr. Steven Quay, Atossa’s President and Chief Executive
Officer. “The data will show us if the 40mg dose delivers the
steady-state plasma concentrations required to effectively target
PKCβ1 inhibition and enhance (Z)-endoxifen’s antitumor mechanism of
action, or if we need to further optimize the dose. Identifying the
optimal dose is an important milestone as it will allow us to
activate additional sites in the US and advance plans to open sites
outside of the US, which will increase the speed of recruitment for
the EVANGELINE treatment cohort.”
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.
We are 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
CONTACTS:Greg WeaverChief
Financial Officergreg.weaver@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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