On April 4, 2017 Atossa Genetics, Inc. (NASDAQ: ATOS) reported 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 (Press release, Atossa Genetics, APR 4, 2017, View Source [SID1234518472]). 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. Schedule your 30 min Free 1stOncology Demo! "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."
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