Canaria Bio (CEO Nahanik) announced on the 30th that it has completed patient recruitment for the global Phase 3 trial of oregovomab targeting newly diagnosed ovarian cancer patients.
The global Phase 3 trial of oregovomab is being conducted at 161 sites across 16 countries, led by Dr. Angeles Secord of the Duke University Cancer Institute in the United States.
This global Phase 3 clinical trial is divided into two cohorts: adjuvant chemotherapy and neoadjuvant chemotherapy. Recruitment for the neoadjuvant chemotherapy cohort was completed in March, and now recruitment for the adjuvant chemotherapy cohort has been closed.
CEO Nahanik stated, “We started patient recruitment in October 2020 and have now completed it after 2 years and 8 months. Due to the impact of COVID-19, the initiation of clinical sites in some countries was significantly delayed, and to compensate, we added about 20 additional clinical sites. Managing over 160 sites across 16 countries is not an easy task. The clinical team, divided across five countries, operated a 24-hour real-time response system, which enabled the successful completion of patient recruitment.”
The adjuvant chemotherapy cohort will randomly assign a total of 372 patients in a 1:1 ratio and will follow the same clinical protocol as the Phase 2 trial, which extended progression-free survival by 30 months.
The adjuvant chemotherapy cohort will report interim results after 117 patients reach progression-free survival (PFS) endpoints and final results after 232 patients reach PFS endpoints. Although the interim analysis was expected as early as the second quarter, the company anticipates a delay until after the third quarter due to fewer than expected relapse cases.
The company explained that in oncology clinical trials using progression-free survival as the primary efficacy endpoint, a delay in patient relapse leading to a postponed interim analysis is not a cause for concern.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.

