Atossa Genetics Announces Successful Completion and Final Results from Male Phase 1 Study of Topical Endoxifen
January 09 2019 - 8:35AM
Atossa Genetics Inc. (NASDAQ:
ATOS), a
clinical-stage biopharmaceutical company developing novel
therapeutics and delivery methods for breast cancer and other
breast conditions, reported final results from its Phase 1
dose-escalation study of its proprietary topical Endoxifen in male
subjects. Atossa reported preliminary results from this study on
September 13, 2018 and those results are now final. All objectives
were successfully met:
- Safety: There were no clinically
significant safety signals and no clinically significant adverse
events in participants receiving topical Endoxifen.
- Tolerability: Topical Endoxifen was well
tolerated at each dose level and for the dosing duration utilized
in the study.
- Pharmacokinetics: Blood samples showed no
measurable Endoxifen.
"These positive final results support the further development of
topical Endoxifen to treat breast health conditions in men,
including a condition called gynecomastia, or breast enlargement
and pain, which frequently occurs in men taking androgen
deprivation therapy for prostate cancer,” commented Dr. Steven C.
Quay, CEO and President. “We are also conducting a Phase 2 study
using our topical Endoxifen in women with mammographic breast
density (MBD) which we anticipate completing in the second quarter
2019. Once we have the results from the MBD study, we will
determine next steps using topical Endoxifen to treat male breast
conditions including gynecomastia,” added Dr.
Quay. The Phase 1 Study Topical
Endoxifen Study in Men The Phase 1 study was a
double-blind, randomized, placebo-controlled, repeat dose study of
24 healthy male subjects. Safety, tolerability and the
pharmacokinetics of proprietary topical Endoxifen formulation at
varying dose levels over 28 days were assessed. The study was
conducted on behalf of Atossa by CPR Pharma Services Pty Ltd.,
Thebarton, SA, Australia. Atossa's
Proprietary Topical Endoxifen We are developing our
proprietary topical Endoxifen to treat or prevent several health
conditions in both men and women. For men, we are developing
topical Endoxifen to prevent and treat a condition called
gynecomastia. Gynecomastia is male breast enlargement and
accompanying pain, which, 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 levels are lower
than estrogen. 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 be the reason some men stop taking
their prescribed medication. In prostate cancer treatment,
testosterone is suppressed resulting in higher estrogen levels that
often 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 approaches in these
patients include pain control and prophylactic breast bud
irradiation which is often repeated. Some patients opt for breast
reduction surgery. Gynecomastia can create quality of life issues,
with some patients attempting to hide the condition with
compression garments. We believe, subject to further clinical
studies and regulatory approval, that our topical Endoxifen could
fill a significant unmet medical need in reducing the risk of
gynecomastia in men taking certain therapies to treat prostate
cancer and helping them maintain their quality of life. For
women, we are also developing topical Endoxifen to treat MBD.
Legislation has been recently enacted in over 30 states requiring
women be notified if they have MBD. These notifications typically
state that women with MBD have a higher risk of developing breast
cancer, and that mammography may not be as effective in detecting
breast cancer because the MBD can "mask" the detection of cancers.
We estimate that approximately 10 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 are
conducting a double-blinded, placebo-controlled Phase 2 study at
Stockholm South General Hospital in Sweden using our topical
Endoxifen. The study is being led by principal investigator Dr. Per
Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and
Biostatistics at Karolinska Institutet in Stockholm. The
primary endpoint is to determine if daily topical Endoxifen
administration results in an individual change in MBD, which will
be measured after three and six months of entering the study. The
secondary endpoints are safety and tolerability. Ninety
participants were randomized to one of three groups (one placebo
group and two groups of different strengths of topical Endoxifen)
with 30 participants per group. The objective of the study is to
determine if MBD is reduced, and if so, the results will drive
sample size calculations for a future Phase III study. Enrollment
has been completed and we expect to complete dosing and report
preliminary results in the second quarter
2019. About Atossa
Genetics Atossa Genetics Inc., is a clinical-stage
biopharmaceutical 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 Guse CFO and General Counsel Office: 866
893-4927 kyle.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
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