Atossa Genetics Inc. reported final results from its Phase 1 dose-escalation study of its proprietary topical Endoxifen in male subjects. Atossa reported preliminary results from this study on September 13, 2018 and those results are now final. All objectives were successfully met: Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen. Tolerability: Topical Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study. Pharmacokinetics: Blood samples showed no measurable Endoxifen. The Phase 1 study was a double-blind, randomized, placebo-controlled, repeat dose study of 24 healthy male subjects. Safety, tolerability and the pharmacokinetics of proprietary topical Endoxifen formulation at varying dose levels over 28 days were assessed. The company is conducting a double-blinded, placebo-controlled Phase 2 study at Stockholm South General Hospital in Sweden using topical Endoxifen. The primary endpoint is to determine if daily topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of entering the study. The secondary endpoints are safety and tolerability. Ninety participants were randomized to one of three groups (one placebo group and two groups of different strengths of topical Endoxifen) with 30 participants per group. The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future Phase III study. Enrollment has been completed and expects to complete dosing and report preliminary results in the second quarter 2019.