CanariaBio Surpasses 80% Recruitment for Global Phase 3 Clinical Trial Patients... "Interim Results Expected This Year"

[Asia Economy Reporter Jang Hyowon] Canaria Bio (CEO Hanik Na) announced on the 5th that 483 out of the 602 target patients for the global Phase 3 trial of Oregovomab for ovarian cancer patients have been recruited, surpassing 80%. This comes two months after exceeding 70%.

The global Phase 3 trial of Oregovomab is being conducted under the leadership of Dr. Angeles Secord from the Duke University Cancer Institute in the United States, targeting newly diagnosed ovarian cancer patients across 152 sites in 16 countries. In South Korea, Seoul National University, Bundang Seoul National University, Yonsei Severance, Seoul Asan, Seoul St. Mary’s, Korea University Anam, and the National Cancer Center are participating in the Phase 3 trial, with Samsung Seoul Hospital and Korea University Guro Hospital added as new sites last month.

This global Phase 3 clinical trial is divided into two cohorts: adjuvant chemotherapy and neoadjuvant chemotherapy. The U.S. FDA has indicated that approval of the new drug is possible if either one of the cohorts is successful.

The neoadjuvant chemotherapy cohort plans to recruit a total of 230 patients. An interim analysis will be conducted after 83 patients complete progression-free survival (PFS), and the final analysis after 165 patients complete PFS. Currently, 203 patients have been recruited, and patient recruitment is expected to be completed by February.

The adjuvant chemotherapy cohort plans to recruit a total of 372 patients. An interim analysis will be conducted after 117 patients complete PFS, and the final analysis after 232 patients complete PFS. Currently, 280 patients have been recruited, and patient recruitment is expected to be completed in the second quarter.

Patient recruitment for this global Phase 3 trial began in October 2020 but was delayed by about a year due to COVID-19. CEO Hanik Na stated, “It has been two years since patient recruitment started, and considering that the number of patients recruited in both cohorts has already far exceeded the number required for the final analysis, we expect to announce interim results for the neoadjuvant chemotherapy cohort as early as the second quarter and for the adjuvant chemotherapy cohort in the third quarter.”

Oregovomab showed encouraging results in Phase 2 clinical trials conducted in the United States and Italy, with progression-free survival (PFS) extended by 30 months compared to the existing standard treatment, reaching 42 months. The P-value for PFS was 0.0027, and for overall survival (OS) was 0.0043. A P-value below 0.05 is considered statistically significant, indicating clinical success.