On May 19, 2017 Atossa Genetics, Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported that it completed enrollment in the topical arm of its Phase 1 dose escalation study of Atossa’s proprietary Endoxifen (Press release, Atossa Genetics, MAY 19, 2017, View Source [SID1234519230]). 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. Schedule your 30 min Free 1stOncology Demo! "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."
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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.