other material
confidence high
sentiment positive
materiality 0.70
Atossa presents positive PK/tolerability data from Phase 2 EVANGELINE trial of (Z)-endoxifen
ATOSSA THERAPEUTICS, INC.
- 50% of patients on 80 mg (Z)-endoxifen + goserelin met target plasma Css of 500-1,000 ng/mL.
- Tissue Css levels >2x plasma; >90% of patients achieved target tissue levels >500 ng/g.
- Ki-67 ≤10% response rate >85% across doses after 4 weeks, indicating antitumor activity.
- (Z)-endoxifen well tolerated with no Grade 3-4 toxicities; four gynecologic events in 80 mg groups.
- Randomized trial to compare 40 mg + OFS vs exemestane + OFS; recruitment expected to start 2025.