Aravive announces DMC recommends continuation of Phase 1B study of AVB-500
Aravive announced that the independent Data Monitoring Committtee has reviewed the open-label data following the first 28-day treatment cycle for the first six patients in each of the two cohorts of the Phase 1b portion of the Phase 1b/Phase 2 trial of AVB-500 in patients with platinum-resistant recurrent ovarian cancer. The DMC did not identify safety concerns with AVB-500. Importantly, data demonstrated suppression of serum GAS6 levels, a biomarker associated with efficacy in preclinical tumor models, with the current dose. The dosing regimen was predicted by the Phase 1 healthy volunteer study. The DMC unanimously recommended the study continue as planned and enroll additional patients into each cohort to collect additional preliminary efficacy, safety, biomarker and PK/PD data at the current dose. The company remains on track to report interim safety, pharmacodynamic, and pharmacokinetic data for the phase 1b portion in the third quarter of 2019.