Atossa Genetics Inc. (ATOS) (“Atossa” or the “Company”), a
clinical-stage pharmaceutical company developing novel therapeutics
and delivery methods to treat breast cancer and other breast
conditions, today announced that it has opened a Phase 2 study of
its proprietary oral Endoxifen to treat breast cancer in the
“window of opportunity” setting, which is the period between
diagnosis of breast cancer and surgery.
“Once a patient is diagnosed with breast cancer, there is a
window of time, typically a number of weeks, before definitive
surgery is performed,” commented Steve Quay, Ph.D., MD, President
and CEO of Atossa. “Our goal with this study is to show that our
proprietary oral Endoxifen can modify the cancer activity in
estrogen-receptor-positive patients during this ‘window of
opportunity.' Tamoxifen, the current standard of care, has not been
effective in this setting, probably because it can take 50-200 days
to reach steady-state of Endoxifen blood levels, while the surgery
is usually completed within 30 to 45 days of diagnosis. Because our
Phase 1 study indicated that our oral Endoxifen reaches therapeutic
levels within 8 hours and therapeutic steady-state levels in only
seven days, we are optimistic we can achieve a valuable treatment
effect,” added Dr. Quay.
The Pilot Phase of the study will initially enroll up to eight
newly-diagnosed patients with Estrogen Receptor Positive (ER+) and
HER2 negative (HER2-) stage 1 or 2 invasive breast cancer,
requiring mastectomy or lumpectomy. Patients will receive Atossa’s
proprietary oral Endoxifen for at least 21 days from the time of
diagnosis up to the day of surgery. Provided tumor activity
reduction is demonstrated in at least two patients, an additional
17 patients will be enrolled for a total of 25. The U.S. FDA has
provided a guidance document on “window of opportunity” or
neoadjuvant studies entitled “Guidance for Industry Pathological
Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage
Breast Cancer: Use as an Endpoint to Support Accelerated Approval.”
URL: https://www.fda.gov/downloads/drugs/guidances/ucm305501.pdf.
The Company is using this document to inform this study and its
design.
The primary endpoint is to determine if the administration of
oral Endoxifen reduces the tumor activity as measured by Ki-67,
which is a marker of cellular proliferation. The secondary
endpoints are safety and tolerability and assessment of the study
drug on expression levels of both estrogen and progesterone
receptors. The impact on additional markers of cellular activity
will also be explored.
The Phase 2 study is being conducted on behalf of Atossa by CPR
Pharma Services Pty Ltd., Thebarton, SA, Australia. CPR Pharma
recently completed the successful Phase 1 study of Atossa’s oral
and topical Endoxifen in women.
A summary of Atossa’s current Endoxifen clinical pipe-line is as
follows:
- Phase 2 study of oral Endoxifen to treat stage 1 or 2 breast
cancer that is ER+ and HER2- in the “window of opportunity”
setting: now open
- Phase 2 study of topical Endoxifen to treat mammographic breast
density: opened in June 2018
- Phase 1 study of topical Endoxifen to treat gynecomastia in
men: dosing and clinical visits completed; preliminary data to be
reported in Q3 2018
- Phase 2 study of topical Endoxifen to treat gynecomastia in
men: subject to Phase 1 results, the Phase 2 is anticipated to
commence in Q4 2018
- Phase 2 study of oral Endoxifen to treat breast cancer
survivors who are refractory to tamoxifen: anticipated to commence
in 2H 2018
Atossa’s Proprietary Endoxifen
Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an
FDA-approved drug to prevent new breast cancer as well as recurrent
breast cancer in breast cancer patients. Tamoxifen itself must be
broken down by the liver into active compounds (metabolites), of
which Endoxifen is the most active. Up to half of the patients
taking tamoxifen, however, do not produce therapeutic levels of
Endoxifen, frequently because of metabolism problems. Tamoxifen
also has some very rare but serious adverse side effects, which can
include stroke, blood clots, pulmonary embolism, blindness, and
endometrial cancer. Because of these drawbacks of Tamoxifen, Atossa
is developing oral and topical forms of Endoxifen.
Atossa has completed a comprehensive Phase 1 clinical study
using both its topical and an oral formulation of Endoxifen.
Results from the Phase 1 study indicated that there were no
clinically significant safety signals and no clinically significant
adverse events and both the oral and topical Endoxifen were well
tolerated. In the topical arm of the study, low but measurable
Endoxifen levels were detected in the blood in a dose-dependent
fashion. In the oral arm of the study, participants exhibited
dose-dependent Endoxifen levels that met or exceeded the published
therapeutic level. The median time for patients in the study
to reach the steady-state serum levels of Endoxifen while taking
daily doses of Atossa’s oral Endoxifen was 7 days. Published
literature indicates that it takes approximately 50-200 days for
patients to reach steady-state Endoxifen levels when taking daily
doses of oral tamoxifen.
Oral Endoxifen Opportunities
In addition to the window of opportunity setting, Atossa is also
developing our proprietary oral Endoxifen for breast cancer
patients who are refractory to Tamoxifen. Approximately one million
breast cancer patients take Tamoxifen to prevent recurrent and new
breast cancer; however, up to 50% of those patients are refractory
to Tamoxifen, meaning they do not produce therapeutic levels of
Endoxifen. This is often because the Tamoxifen is not properly
metabolized into Endoxifen. “We believe our oral Endoxifen may
provide an effective treatment supplement or option for these
refractory patients because Endoxifen, unlike Tamoxifen, does not
require liver metabolism,” stated Steve Quay.
Topical Endoxifen Opportunities
Atossa is developing its proprietary topical Endoxifen to reduce
MBD, which has been shown in studies conducted by others to be an
independent risk factor for developing breast cancer. To date, 34
U.S. states have enacted laws requiring that findings of MBD be
communicated to the patient. According to the National Cancer
Institute approximately 10 million women in the U.S. have high
breast density (BI-RAD level C or D with “D” being the highest).
Although oral Tamoxifen has been shown to reduce MBD, the
benefit-risk ratio is generally not acceptable to most patients.
For example, it is estimated that only ~ 2% of women at high-risk
of developing breast cancer, including those with MBD, take oral
Tamoxifen to prevent breast cancer because of the risks of, or
actual side-effects of oral Tamoxifen. There is no FDA-approved
treatment for MBD.
In June 2018, Atossa opened a Phase 2 double-blinded
placebo-controlled study of topical Endoxifen to treat MBD. The
study is being conducted at Stockholm South General Hospital in
Sweden by principal investigator Dr. Per Hall, MD, Ph.D., Head of
the Department of Medical Epidemiology and Biostatistics at
Karolinska Institutet. The primary endpoint is MBD reduction, as
well as safety and tolerability. The study includes 90
participants: 30 on each of two different doses of topical
Endoxifen and 30 on placebo.
Atossa is also developing topical Endoxifen for a condition in
men called gynecomastia, which is male breast enlargement, and
according to the Mayo Clinic affects 25% of men in the U.S. between
the ages of 50-69, or approximately 10 million men. It is the
most common male breast disorder and is caused by a hormone
imbalance where testosterone is low compared to estrogen. In
prostate cancer treatment, testosterone is suppressed with androgen
deprivation therapy resulting is higher estrogen levels that
usually triggers gynecomastia. One recent study indicates that up
to 90% of men taking androgen deprivation therapy suffer from
gynecomastia and breast pain (Handoo Rhee, et al., October 18,
2014, BJU International). There is no FDA-approved
pharmaceutical to treat gynecomastia. Current therapeutic
approaches in these patients include the daily use of oral
estrogen-suppressing medications and prophylactic breast bud
irradiation which is often repeated.
Atossa has completed dosing and clinical visits in a Phase 1
study in men using topical Endoxifen and it plans to announce
preliminary results from this study in the third quarter
2018. The objectives of the placebo-controlled, repeat dose
study of 24 healthy male volunteers are to assess the
pharmacokinetics of a proprietary topical Endoxifen dosage form
over 28 days, as well as to assess safety and
tolerability.
About Atossa Genetics
Atossa Genetics Inc. is a clinical-stage pharmaceutical company
developing novel therapeutics and delivery methods to treat breast
cancer and other breast conditions. For more information, please
visit www.atossagenetics.com.
Forward-Looking Statements
Forward-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
preliminary 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, lower than
anticipated rate of patient enrollment, estimated market size of
drugs under development, the safety and efficacy of Atossa's
products and services, performance of clinical research
organizations and investigators, obstacles resulting from
proprietary rights held by others with respect to fulvestrant, such
as patent rights, potential market sizes for Atossa’s drugs under
development 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 Genetics Company Contact:
Atossa Genetics Inc.Kyle GuseCFO and General
Counsel(O) 866 893-4927kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott GordonCoreIR377 Oak StreetConcourse
2Garden City, NY 11530Office: 516 222-2560scottg@CoreIR.com
Source: Atossa Genetics Inc.
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