Canary Bio Achieves 50% Enrollment in Global Phase 3 Clinical Trial... Passes DSMB Review

[Asia Economy Reporter Jang Hyowon] Canaria Bio (CEO Hanik Na) announced on the 30th that patient recruitment for the global Phase 3 clinical trial of oregovomab targeting ovarian cancer patients, with a recruitment goal of 602 patients, has surpassed 50%.

This global Phase 3 clinical trial is recruiting patients at 160 sites across 16 countries including Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Hungary, Italy, Korea, Mexico, Poland, Spain, Taiwan, India, Romania, and the United States.

In Korea, Seoul National University Hospital, Bundang Seoul National University Hospital, Yonsei University Severance Hospital, Seoul Asan Hospital, Catholic University Seoul St. Mary's Hospital, Korea University Anam Hospital, and the National Cancer Center are participating in the global Phase 3 clinical trial. The company plans to complete patient recruitment for the Phase 3 trial by the end of 2022 and announce interim results in 2023. Information about the clinical trial can be found in the U.S. clinical information system under NCT number 04498117.

This trial is conducted as a double-blind, placebo-controlled study comparing patients receiving oregovomab in combination with chemotherapy agents (carboplatin and paclitaxel) to those receiving chemotherapy alone. The primary endpoint is progression-free survival (PFS).

At the DSMB (Data Safety Monitoring Board) meeting held in March 2022, a recommendation was made to continue the trial. The DSMB has the authority to stop the trial not only in cases of serious safety issues but also if efficacy is deemed insufficient. The next DSMB review is scheduled for September 2022.

Chief Medical Officer (CMO) Dr. Sunil Gupta stated, “We are pleased to have reached this important milestone, which is evidence of the efforts of all team members and partners, and we thank the patients who participated in the study,” emphasizing, “We have high expectations for the potential life-extending benefits that oregovomab can bring to ovarian cancer patients.”