Atossa Genetics Receives Approval from the Swedish Medical Products Agency for Phase 2 Topical Endoxifen Study

Study’s Endpoints Are Changes in Mammographic Breast Density, Tolerability, and Safety

SEATTLE, April 30, 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, announced today that it has received approval from the Swedish Medical Products Agency (MPA) 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 and may potentially improve the accuracy of mammography in finding 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. Atossa plans to open the study for enrollment this quarter.

The primary endpoint is individual change in MBD, which will be measured after three and six months of entering the study, and the secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups on different doses of topical Endoxifen) with 30 participants per group. The objective of the study is to determine the effect size of breast density between the topical and active groups, which will permit sample size calculations in a future Phase III study.

“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.

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 Opportunities

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 risks of, or actual side-effects of, oral tamoxifen.

Atossa is also developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement, which affects 25% of men between the ages of 50-69.  Atossa has commenced a Phase 1 study in men using topical Endoxifen, which it plans to fully-enroll this quarter. 

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.

The Medical Products Agency

The Medical Products Agency is the government agency in Sweden responsible for regulation and surveillance of the development, manufacturing and sale of medicinal drugs, medical devices and cosmetics.

The Swedish Medical Products Agency is one of the leading regulatory authorities in the EU. During the last five years, the Swedish MPA has been among the top three agencies in Europe, counting the number of approval processes managed for central (i.e. European) approvals of medicines. The Swedish MPA also has strong representation in more than 110 working groups and committees in the scope of the Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) for regulation of medical products in Europe.

The Medical Products Agency is a government body under the aegis of the Swedish Ministry of Health and Social Affairs. Its operations are largely financed through fees. Approximately 750 people work at the agency; most are pharmacists and doctors.

Breast Cancer Statistics

The American Cancer Society (ACS) estimates that approximately 268,000 women will be diagnosed with breast cancer in the United States this year and that approximately 41,000 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 in 2018 2,550 new cases of invasive breast cancer will be diagnosed in men; and 480 men will die from breast cancer.

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, 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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Source: Atossa Genetics Inc.