Atossa Genetics Completes Enrollment in Topical Arm of Endoxifen Phase 1 Study
SEATTLE, WA -- (Marketwired) -- 05/19/17 -- Atossa Genetics, Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced that it completed enrollment in the topical arm of its Phase 1 dose escalation study of Atossa's proprietary Endoxifen. Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is used to treat breast cancer and for breast cancer prevention in high risk patients.
"We have reached a significant milestone by completing enrollment in the topical arm of our Endoxifen Phase 1 study," stated Steven Quay, CEO and President. "We are very pleased with the rapid progress of this study and look forward to now enrolling participants in the other half of the study which consists of 24 participants receiving an oral formulation of our proprietary Endoxifen."
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.
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.
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Source: Atossa Genetics, Inc.