Atossa Genetics Announces Successful Completion and Final Results from Male Phase 1 Study of Topical Endoxifen

SEATTLE, Jan. 09, 2019 (GLOBE NEWSWIRE) -- 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 

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 

Investor Relations Contact: 

Scott Gordon
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516 222-2560

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