Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”), today announced that the pre-menopausal, Estrogen
Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2
negative (HER2-), breast cancer patient who received neoadjuvant
and adjuvant (Z)-endoxifen therapy under an FDA-approved "expanded
access" program has completed five years of treatment. As of the
date of this press release, the patient remains cancer-free and has
reported no significant safety or tolerability issues over the
course of her treatment. Atossa is a clinical stage
biopharmaceutical company developing innovative medicines in areas
of significant unmet medical need in oncology with a focus on
breast cancer.
"We believe this patient, and her successful treatment journey,
is representative of the opportunity (Z)-endoxifen has to change
the treatment paradigm for the approximately 250,000 women
diagnosed with estrogen receptor positive breast cancer each year
in the U.S.,” said Steven Quay, M.D., Ph.D., Atossa’s President and
Chief Executive Officer. "The current standard of care is
sub-optimal as it often requires ovarian suppression in
premenopausal women and aromatase inhibitors in postmenopausal
women, both of which are associated with potential short-term and
long-term side effects that diminish adherence. Over five years of
adjuvant treatment, her daily (Z)-endoxifen treatment has been well
tolerated, and there were no vasomotor symptoms commonly associated
with standard of care adjuvant pharmaceuticals. She remains
cancer-free today and we are grateful to have been able to help her
with a difficult treatment problem.”
Patient / Treatment Background
Diagnosis. In late 2018, a 51-year-old
premenopausal woman was diagnosed with a moderately differentiated
invasive ductal breast carcinoma with the most frequently reported
subtype: ER+, PR+, and HER2-. The initial diagnostic biopsy
demonstrated that 90% of the tumor cells were ER+ and 20% expressed
Ki-67, a tumor proliferation antigen. Pharmacogenomics analysis
showed a CYP2D6 genotype of CYP2D6*4/*4, a nonfunctioning variant,
suggesting tamoxifen would be a poor treatment option.
Other than breast cancer, the patient had no comorbidities and
took no medications. Her family history was strong for
osteoporosis, a contraindication for aromatase inhibitor
treatment.
Neoadjuvant treatment. Neoadjuvant treatment is
given in the window of time between the diagnosis and the primary
treatment, which in the case of locally advanced breast cancer is
surgery. The intent of neoadjuvant therapy is to slow the growth of
the cancer or even shrink the cancer prior to surgery. The goal of
this treatment is to help increase the effectiveness of surgery,
and it has also been shown to reduce the likelihood that the cancer
returns.
The FDA authorized a single-patient study under its Expanded
Access or compassionate use program for this woman to receive 4
mg/day oral (Z)-endoxifen for 20 days before surgery.
Surgery. The patient had a unilateral
mastectomy. After (Z)-endoxifen neoadjuvant treatment, the Ki-67
expression in the tumor was reduced 50%, from 20% to 10%. Both the
relative response, a 50% reduction, and the absolute value at the
time of surgery have been found in large trials to be an indicator
of favorable long-term outcomes.
Adjuvant treatment. Following surgery, her
physician recommended adjuvant therapy but, like many women, she
was not a candidate for tamoxifen due to her low liver enzyme
(CYP2D6) activity. She also did not want to take drugs to suppress
her ovarian function and go into early menopause, which meant
aromatase inhibitors were not an option. Given the strong and rapid
response to (Z)-endoxifen, it was recommended that she continue
taking (Z)-endoxifen. This led to an additional compassionate use
authorization by the FDA to allow this patient to continue taking 4
mg/day (Z)-endoxifen in the adjuvant setting.
She has now completed five years of daily (Z)-endoxifen. As of
the date of this press release, she has not had a recurrence of
breast cancer or a new cancer in the contralateral breast, as
assessed by clinical examination and mammography. Additionally, the
treatment has been well tolerated, and there were no vasomotor
symptoms commonly associated with tamoxifen (for example, night
sweats and hot flashes).
Under the FDA Expanded Access IND program, the use of Atossa's
proprietary (Z)-endoxifen is restricted to this patient only.
About FDA Expanded AccessSometimes called
"compassionate use," expanded access is a potential pathway for a
patient with an immediately life-threatening condition or serious
disease or condition to gain access to an investigational medical
product (drug, biologic, or medical device) for treatment outside
of clinical trials when no comparable or satisfactory alternative
therapy options are available.
Expanded access may be appropriate when all the following apply:
the patient has a serious disease or condition, or whose life is
immediately threatened by their disease or condition; there is no
comparable or satisfactory alternative therapy to diagnose,
monitor, or treat the disease or condition; patient enrollment in a
clinical trial is not possible; potential patient benefit justifies
the potential risks of treatment; providing the investigational
medical product does not interfere with investigational trials that
could support a medical product's development or marketing approval
for the treatment indication; alternative investigational drugs,
biologics or medical devices have not yet been approved or cleared
by FDA and FDA has not found these products to be safe and
effective for their specific use; and alternative investigational
medical product may, or may not, be effective in the treatment of
the condition, and use of the product may cause unexpected serious
side effects.
For more information, see the FDA website: FDA Expanded Use
Website.
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 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 using (Z)-endoxifen to prevent and treat
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, including the timing of data related to the (Z)-endoxifen
program, the potential of (Z)-endoxifen as a breast cancer
prevention and treatment agent, and the potential safety and
tolerability profile of (Z)-endoxifen, 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 comply 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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