SEATTLE, WA--(Marketwired - Apr 4, 2017) - Atossa Genetics, Inc. (NASDAQ: ATOS) today announced that it has fully enrolled the first of six cohorts (eight participants per cohort) in its Phase 1 study of endoxifen, which is an active metabolite of tamoxifen, an FDA approved drug for breast cancer and breast cancer prevention in high risk women. The objectives of this double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects is to assess the pharmacokinetics of proprietary formulations of both oral and topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted in two parts based on route of administration.
"Less than ten months ago we announced that we had begun a program to develop endoxifen for cancer patients who don't benefit from taking tamoxifen and for women at high risk of developing breast cancer who are not taking tamoxifen, often due to concerns about side effects from system exposure. Through the hard work and dedication of Atossa's employees and our collaborators we have obtained a qualified manufacturer of the active pharmaceutical ingredient, performed formulation development for both oral and topical dosage forms, established a manufacturer of the finished dosage forms, and launched the first human testing in a Phase 1 study," stated Steven Quay, CEO and President. "I am not aware of any oncology company that has completed the pre-clinical phase of drug development so quickly."
The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.
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 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 actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, results of clinical studies, 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, 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.