Atossa Genetics is a healthcare company focused on the development of locally-administered pharmaceuticals for the treatment of pre-cancer and early stage breast cancer.
Our leading pharmaceutical under development is Afimoxifene Topical Gel, or AfTG, which is in Phase II clinical development. We are also planning a Phase II clinical trial using our patented intraductal Microcatheters to deliver fulvestrant to treat ductal carcinoma in-situ, or DCIS, and breast cancer.
In May 2015, we acquired the worldwide exclusive rights to develop and commercialize AfTG for the potential treatment and prevention of hyperplasia of the breast and the rights to expand the license to other indications including breast cancer. AfTG has been used in 16 Phase I and Phase II studies conducted in a variety of indications with over 450 patients. We are in the process of re-establishing the clinical supply of AfTG and plan to commence a Phase II clinical trial in 2016. The National Cancer Institute, Division of Cancer Prevention, has approved a Letter of Intent submitted by a member of the Consortia for Cancer Prevention Clinical Trials Program for the study of AfTG in women with DCIS. The Consortia includes five major medical research centers: the University of Arizona, Northwestern University, Mayo Clinic Foundation, M. D. Anderson Cancer Center and the University of Wisconsin.
In October 2015 the FDA accepted our investigational new drug application, or IND, to commence a Phase II clinical study using fulvestrant administered via our patented intraductal Microcatheters to treat DCIS and breast cancer. We expect this study will be performed by Columbia University Medical Center and will commence in the very near term.
We have also developed medical devices, which include our ForeCYTE Breast Aspirator for distribution outside the United States and the FullCYTE Breast Aspirator for the U.S. market. These devices are intended for the collection of nipple aspirate fluid, or NAF, for cytological testing at a laboratory. The current version of the ForeCYTE Breast Aspirator is CE-marked and the FullCYTE Breast Aspirator has been cleared by the FDA. We are not, however, currently marketing and promoting our breast aspirators as we are devoting substantially all of our resources to our pharmaceutical business. Other devices under development include intraductal Microcatheters for the potential administration of targeted pharmaceuticals, and various tools for potential use by breast surgeons.
Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics commented, “The sale of the NRLBH represents an opportunity for Atossa to more fully focus our resources and efforts towards the development of our pharmaceuticals. The sale is structured so that we have the potential to receive significant proceeds from the sale based on potential gross revenue of the NRLBH and through our 19% stake in Preferred Stock. We are very impressed with the buyer’s experience and capabilities in successfully growing businesses, including in the healthcare space, and are confident in their abilities to succeed with our laboratory business and we look forward to sharing in that success. We remain highly optimistic and fully committed to our future development of therapeutics that we believe can dramatically alter the current standard of care in pre-cancer and early stage breast cancer.”
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health by developing locally-administered pharmaceuticals for the treatment of pre-cancerous conditions and early stage breast cancer. For more information, please visit www.atossagenetics.com.
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, whether the earn-out for the sale of the NRLBH will be achieved and paid 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.