On May 10, 2017 Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company, reported that it has received the second positive interim review on its Phase 1 study of endoxifen, which is an active metabolite of the FDA approved drug tamoxifen, which is indicated for breast cancer and breast cancer prevention in high risk patients (Press release, Atossa Genetics, MAY 10, 2017, View Source [SID1234518976]). The Independent Safety Committee reviewed the blinded data generated from the second cohort of the study (8 subjects) and concluded that the study may advance to the final topical dosing level. Schedule your 30 min Free 1stOncology Demo! "This is the second positive safety determination for our Phase 1 study," stated Steven Quay, CEO and President. "The first safety determination allowed us to proceed to the current dosing level and now this additional interim safety determination indicates that proceeding to the final dosing level with our proprietary topical Endoxifen is warranted."
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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.