SEATTLE, May 15, 2018 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (NASDAQ: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 received a second positive interim safety review on its Phase 1 study of topical Endoxifen
in men, which is being developed to address gynecomastia (or male breast enlargement), a common condition in patients being treated
for prostate cancer. The Independent Safety Committee reviewed the blinded data generated from the second group in the study (eight
subjects) and concluded that the study may advance to the final dosing level.
Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa commented, "We can now advance to the next level of the study which is
to escalate the dosage in the third and final cohort of subjects as we continue to monitor safety and tolerability in the first and
second cohorts of the study. We plan to complete enrollment this quarter and announce results from the study next quarter,” added
Dr. Quay.
The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects is to assess the
pharmacokinetics of proprietary formulations of topical endoxifen dosage forms over 28 days, as well as to assess safety and
tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.
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 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 Guse
CFO and General Counsel
(O) 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
Source: Atossa Genetics Inc.