Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical
company developing novel therapeutics and delivery methods for
breast cancer and other breast conditions, announced today that is
has fully enrolled the first of three cohorts in its Phase 1 study
of its proprietary topical Endoxifen in men. The objectives of the
placebo-controlled, repeat dose study of 24 healthy male volunteers
are to assess the pharmacokinetics of proprietary topical Endoxifen
dosage forms over 28 days, as well as to assess safety and
tolerability.
Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa,
commented that “We are very impressed with the speed at which this
program is progressing. The first of three cohorts is now enrolled
and we expect to enroll the other two cohorts this quarter. This
study should serve as a basis for future development into mens’
breast health, including male breast cancer and gynecomastia, which
affects 1 in 4 men between ages 50-69 and up to 90% of men taking
androgen deprivation therapy for prostate cancer. Men being treated
for prostate cancer currently have limited options to address the
gynecomastia that is associated with their cancer treatment, such
as breast-bud irradiation, estrogen suppression therapy and
surgery.”
The 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.
About Gynecomastia
Gynecomastia is male breast enlargement and accompanying pain.
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 resulting
is higher estrogen levels that usually triggers gynecomastia.
Prophylactic breast bud irradiation is commonly used in prostate
cancer patients, but must often be repeated. 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).
According to the Mayo Clinic, although it can affect men at
almost any age, it is most prevalent in men ages 50-69, affecting
at least 1 in 4 men in this age group. Gynecomastia is caused by,
among other things, any number of commonly prescribed medications,
such as androgen deprivation therapy to treat prostate enlargement
and prostate cancer; anti-anxiety medications; cancer treatments
(chemotherapy), and some heart medications. Gynecomastia is not
only painful and embarrassing, it can also cause men to stop taking
these important medications.There are no FDA-approved therapeutics
for gynecomastia. Breast-bud irradiation, use of compression
garments and plastic surgery are the most common approaches used to
treat gynecomastia.
About Breast Cancer
The American Cancer Society (ACS) estimates that approximately
266,000 women will be diagnosed with breast cancer in the United
States this year and that approximately 41,000 will die from the
disease. It is the second leading cause of cancer death in American
women. Although about 100 times less common than women, breast
cancer also affects men. The ACS estimates that the lifetime risk
of men getting breast cancer is about 1 in 1,000; 2,550 new cases
of invasive breast cancer will be diagnosed; and 480 men will die
from breast cancer in 2018.
Similar to women, the treatment for male breast cancer is
typically surgery (with or without radiation) and
chemotherapy. Breast cancer in men is deadlier than breast
cancer in women: men with early-stage breast cancer have a lower
five-year survival rate than women and breast cancer in men tends
to be detected at a later stage of development than women (Jon M.
Greif, DO, FACS, et al., May 2012, American Society of Breast
Surgeons). Although tamoxifen is the standard of care for women to
prevent new and recurrent breast cancer, there is no FDA-approved
treatment for male breast cancer.
About Endoxifen
Oral tamoxifen has been widely used for over 40 years to both
treat and prevent breast cancer. Tamoxifen, however, has
significant drawbacks: First, it can cause side effects including
headaches, nausea and early menopausal symptoms as well as rare but
serious side effects such as cataracts, stokes and cancer of the
uterus. Second, tamoxifen is a “pro-drug,” meaning that it must be
processed by the liver in order to produce therapeutic (“active”)
metabolites. The metabolite in tamoxifen that accounts for most of
its therapeutic activity is called Endoxifen. Unfortunately, up to
50% of breast cancer survivors who are taking tamoxifen do not
produce therapeutic levels of Endoxifen (meaning they are
“refractory”) for a number of reasons, including that they, due to
their genotype, do not have the requisite liver enzymes.
Additionally, it can take from 50-200 days for tamoxifen to reach
“steady-state” meaning that the drug may be providing little or no
benefit for up to several months after starting
treatment. Atossa is developing topical Endoxifen for
women with mammographic breast density, or MBD, and for men with
gynecomastia or breast cancer. There is no FDA-approved therapeutic
for gynecomastia and male breast cancer. We estimate that
approximately ten million women in the Unites States have MBD, for
which there is no FDA-approved treatment. Although oral tamoxifen
is approved to prevent breast cancer in “high-risk” women, it is
used by less than 5% of women with an increased risk of developing
breast cancer because of the actual or perceived side effects and
risks of tamoxifen. We believe our topical Endoxifen may provide an
effective treatment for MBD because, unlike an oral medication, it
is applied directly to the breast and penetrates the skin; it does
not require metabolism by the liver; and it may produce fewer side
effects than tamoxifen. Moreover, our topical Endoxifen may improve
mammography accuracy and patient care by unmasking cancerous tumors
that are otherwise hidden by breast density, and reduce the risks
of over diagnosing potential tumors when more highly sensitive
imaging methods are used. Second, we are developing 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. 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.
We recently completed a comprehensive Phase 1 study in 48
healthy women in Australia using both the topical and oral forms of
our proprietary Endoxifen. We concluded that all objectives were
successfully met in both arms of the study: 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, there were low but
measurable Endoxifen levels detected in the blood in a
dose-dependent fashion and in the oral arm of the study
participants exhibited dose-dependent Endoxifen levels in published
reports of the therapeutic range. The median time for patients in
the study to reach the steady-state serum levels of Endoxifen while
taking daily doses of 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. Finally, the median time for patients in
the study to reach the maximum serum level of Endoxifen after
taking Atossa’s oral Endoxifen ranged from 4 to 8 hours (depending
on dose). The 4 mg dose of Endoxifen produced a maximum serum
level of Endoxifen in 4 to 8 hours at levels above the generally
accepted threshold for a therapeutic effect on estrogen-dependent
breast cancer.
In September 2017, we contracted Stockholm South General
Hospital in Sweden to conduct a Phase 2 study of our topical
Endoxifen. The primary endpoint is MBD reduction, as well as safety
and tolerability. We also plan to commence a Phase 2 clinical study
using our oral Endoxifen for patients who are refractory to
tamoxifen. Our Phase 1 study of topical Endoxifen in men is now
underway and we have enrolled the first of three cohorts in that
study.
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, lower than anticipated rate of patient enrollment,
preliminary and final results of clinical studies, 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, 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 Guse
CFO and General Counsel (866)
893-4927kyle.guse@atossagenetics.com
Investor Relations Contact:Scott Gordon CoreIR 377 Oak Street
Concourse 2 Garden City, NY 11530 Office: 516.222.2560
scottg@CoreIR.com
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Apr 2023 to Apr 2024