SEATTLE, June 20, 2018 (GLOBE NEWSWIRE) -- 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 completed dosing and clinical visits in its Phase 1 study of its proprietary topical
Endoxifen in men.
“We are now proceeding to the final stages of this study, which are to complete analysis of blood samples and then collect and
analyze the data,” commented Steve Quay, Ph.D., M.D., President and CEO of Atossa. “We expect to report preliminary results from
the study in the next quarter,” added Dr. Quay.
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.
Atossa is developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement. According
to the Mayo Clinic, 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men, suffer from
gynecomastia. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low
compared to estrogen. For example, 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’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. Many patients taking tamoxifen, however, do not properly metabolize tamoxifen
into therapeutic levels of Endoxifen.
Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen in women.
Results from the topical arm of the Phase 1 study in women indicated that the topical formulation was safe, well tolerated and that
topical Endoxifen crossed the skin barrier in a dose-dependent fashion.
Topical Endoxifen Opportunities
In addition to gynecomastia, Atossa is also developing its proprietary topical Endoxifen to reduce Mammographic Breast Density
(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. And according to the National
Cancer Institute, approximately 10 million women in the U.S. have high breast density (BI-RADS 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.
Atossa is planning a Phase 2 study of its topical Endoxifen in women with MBD. The study will be conducted at Stockholm South
General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical
Epidemiology and Biostatistics at Karolinska Institutet.
The primary endpoint of this study is to determine if topical Endoxifen administration results in an individual change in MBD,
which will be measured after three and six months. Secondary endpoints are safety and tolerability. The objective of the study is
to determine the effect size on MBD between the placebo and active groups, which will permit sample size calculations in a future
Phase III study. Enrollment is anticipated to be completed by the end of 2018.
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.
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