ATOS Atossa Therapeutics Inc

Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions has contracted with a leading European hospital to conduct a Phase 2 study of its proprietary topical Endoxifen for the treatment of women with mammographic breast density, or MBD. Studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer. The Phase 2 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.

“Dr. Hall is widely regarded as a leading researcher in the field of breast cancer and prevention.  He is heading the unique KARMA (Karolinska Mammography Project for Risk Prediction of Breast Cancer) Cohort, including over 70,000 women, which is regarded as the best characterized breast cancer cohort in the world and serves as a resource for studies about breast cancer risk assessment and prevention, and the Karisma Intervention Study, which is studying the change in MBD in women taking various doses of oral tamoxifen. We are honored to be working with Dr. Hall and his colleagues on our Phase 2 study of MBD as their unique experience and qualifications are simply unmatched anywhere in the world,” said Dr. Steven C. Quay, CEO and President of Atossa Genetics.

Atossa plans to apply for approval from the Institutional Review Board and Swedish regulatory authority (Medical Products Agency) within the next 30 days. The placebo-controlled, double-blinded study is expected to enroll up to 480 subjects. The primary endpoint is MBD reduction, which will be measured after six and twelve months of dosing, as well as safety and tolerability.

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. Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen. Preliminary results from the topical arm of the study indicated that the topical formulation was safe, well tolerated and that topical Endoxifen crossed the skin barrier in a dose-dependent fashion.

Topical Endoxifen Opportunity: MBD. Atossa is developing its proprietary topical Endoxifen to reduce MBD, which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 30 U.S. states require that findings of MBD be directly communicated to the patient. Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most physicians and their 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 risk of, or actual side-effects of, oral tamoxifen.

Oral Endoxifen Opportunity. Approximately one million breast cancer survivors take oral tamoxifen annually; however, up to half of them do not properly metabolize tamoxifen and do not have desired levels of Endoxifen (meaning they are “refractory”). Low Endoxifen levels in breast cancer patients taking oral tamoxifen are associated with an increased risk of recurrence or the development of new breast tumors. Providing oral Endoxifen directly to the patient without having to be metabolized by the liver may help to address this problem.

Based on the number of women at high-risk of developing breast cancer and the number of patients who have survived breast cancer but are refractory to tamoxifen, Atossa estimates that the potential markets for its proprietary oral and topical formulations of Endoxifen could each potentially exceed $1 billion in annual sales.

Breast Cancer Statistics

The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 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; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017. 

About Stockholm South General Hospital

Stockholm South General Hospital is one of the largest hospitals in Sweden, offering care to more than two million Stockholmers. It is one of four hospitals collaborating with Karolinska on the KARMA project. For more information, please visit http://www.sodersjukhuset.se/Functions/InEnglish/.

About Karolinska Institutet

Karolinska Institutet, located in Stockholm, Sweden, is one of the world’s foremost medical universities. Its vision is to make a significant contribution to the improvement of human health; its mission is to conduct research and education and to interact with the community. As a university, KI is Sweden’s single largest center of medical academic research and offers the country’s widest range of medical courses and programs. The Nobel Assembly at Karolinska Institutet selects the Nobel laureates in Physiology or Medicine. For more information, please visit www.ki.se/en and www.KARMAstudy.org.

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 and other regulatory authorities, the outcome or timing of regulatory approvals needed by Atossa, 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 GuseCFO and General Counsel(O) 866 893-4927kyle.guse@atossagenetics.com

Investor Relations Contact:

Scott GordonCoreIR377 Oak StreetConcourse 2Garden City, NY 11530Office: 516 222-2560scottg@CoreIR.com