Atossa Genetics announces preliminary results from Phase 1 study of Endoxifen
Atossa Genetics reported preliminary results from its Phase 1 study of its proprietary modified-release tablet form of oral Endoxifen. All objectives were successfully met: There were no unexpected and serious adverse events; no clinically significant adverse safety signals; and no clinically significant adverse events in participants receiving the tablet form of oral Endoxifen. No participants withdrew or were removed from the study due to skin rashes and irritation or other adverse events. The tablet form of oral Endoxifen was well tolerated by each participant throughout the study. "This was an important study because the results support advancing our modified-release tablet into a Phase 2 study to reduce mammographic breast density, which we plan to begin in the fourth quarter by contracting with a CRO," said CEO Steven Quay. "We will continue our analysis of the Phase 1 data and plan to announce additional results in the coming weeks. We also recently completed a successful Phase 2 study of our topical form of Endoxifen in which a significant reduction of MBD was achieved among study participants who applied the stronger dose of topical Endoxifen. Our success with the topical Phase 2 study and now the successful Phase 1 study of the tablet, supports our plan to advance our proprietary tablet into a Phase 2 study to reduce MBD."