SOURCE: Atossa Genetics, Inc.

Atossa Genetics, Inc.

September 21, 2015 08:00 ET

Atossa Genetics Announces FDA Acceptance of Its Investigational New Drug Application to Begin a Phase II Clinical Trial of Fulvestrant for the Treatment of DCIS

Study to Evaluate Fulvestrant Administered With Atossa's Patented Intraductal Microcatheters; Atossa Now Has Two Phase II Clinical Programs

SEATTLE, WA--(Marketwired - Sep 21, 2015) - Atossa Genetics Inc. (NASDAQ: ATOS), a healthcare company focused on improving breast health through the development of pharmaceuticals to treat breast health conditions and through commercialization of medical devices and laboratory tests, today announced that the U.S. Food and Drug Administration has accepted the Company's Investigational New Drug (IND) application for a clinical trial of Fulvestrant in patients with Ductal Carcinoma in Situ (DCIS) or breast cancer.

Acceptance of the IND by the FDA enables Atossa to now move forward with an open-label, non-randomized pharmacokinetic and safety study of Fulvestrant in women with DCIS or breast cancer who are scheduled for mastectomy. Patients will be treated with either intramuscular Fulvestrant or intraductal instillation of Fulvestrant utilizing Atossa's patented intraductal microcatheter device. Atossa is the owner of an issued patent and several pending applications directed to the treatment of breast conditions, including cancer, by intraductal administration of Fulvestrant. Additional information about the study can be found at: https://clinicaltrials.gov/ct2/show/NCT02540330?term=atossa&rank=2

Sheldon M. Feldman, M.D., of the Columbia University Medical Center Breast Cancer Program is expected to be the principal investigator. The trial is scheduled to commence in December 2015.

"The FDA's acceptance of our Fulvestrant IND is a significant milestone for Atossa that hallmarks a potentially new, locally administered treatment for DCIS via intraductal administration utilizing our patented microcatheters," said Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics." DCIS is a serious medical condition diagnosed in approximately 60,000 women a year in the U.S. The current standard of care for these women includes surgical removal of the tumor, radiation, and/or Tamoxifen treatment and in some cases mastectomy. Together with our Afimoxifene Gel, we now have two Phase II programs underway," he continued.

About Atossa Genetics

Atossa Genetics Inc. is focused on improving breast health through the development of therapeutics, medical devices and laboratory services. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory services and the Company's medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For more information, please visit www.atossagenetics.com.

Forward-Looking Statements

Forward-looking statements in this press release 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 actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to achieve its objectives and continue to manufacture and sell its products, recalls of products, the safety and efficacy of Atossa's products and services, performance of distributors and investigators, whether Atossa can launch in the United States and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, 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.

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