Atossa says preliminary Phase 2 study of Endoxifen achieves primary endpoint
Atossa Genetics announced that a preliminary analysis from its recently completed Phase 2 study of the company's proprietary 20mg daily topical Z Endoxifen showed significant and rapid reduction in mammographic breast density. Studies by others using tamoxifen have demonstrated that density reduction induced by tamoxifen is associated with a significant reduction in breast cancer incidence. A summary of preliminary results of the study follows: MBD was reduced by an average of 14.3 percent in the group applying 20mg daily topical Endoxifen, which was statistically significant. In the lower dose group, MBD was reduced by an average of 9.0 percent. These results are based on MBD measurements at the time of enrollment in the study and again at the time dosing ended, which was a mean of 55 and 88 days for the 20mg and 10mg groups, respectively. Approximately 70 percent of participants receiving 20mg topical Endoxifen experienced a reduction in MBD, and of those, the mean reduction in MBD was 27 percent. There were no significant differences in systemic endocrine or vascular side effects in the placebo versus active groups. Systemic side effects were measured using a modified validated symptom questionnaire. The most commonly experienced side effect for both groups receiving active drug were skin rashes and local irritation. The results indicate a study with approximately 50-100 subjects per dosage group would be appropriate to demonstrate efficacy for regulatory approval purposes.