Canary Bio Adds 9 Sites in India for Global Phase 3 Clinical Trial

[Asia Economy Reporter Jang Hyowon] Canaria Bio (CEO Hanik Na) announced on the 8th that it has added 9 new clinical trial sites in India for the global Phase 3 clinical trial of oregovomab targeting newly diagnosed ovarian cancer patients.

With the addition of 9 sites in India, this Phase 3 clinical trial is now being conducted at a total of 161 sites across 16 countries. Due to delays in patient recruitment caused by COVID-19, Canaria Bio had initially planned to conduct the trial at 130 sites but revised the plan to increase the number to a maximum of 160 sites, achieving this updated goal.

In South Korea, Seoul National University Hospital, Bundang Seoul National University Hospital, Severance Hospital, Seoul St. Mary's Hospital, Korea University Anam Hospital, Asan Medical Center, and the National Cancer Center are participating, with Samsung Medical Center and Korea University Guro Hospital added as new sites in December last year.

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 company expects to see interim results for the neoadjuvant chemotherapy cohort as early as the second quarter.

CEO Hanik Na stated, "We will announce interim results this year and will be able to gauge the clinical outcomes. The P-value in Phase 2 was 0.0027, which is a very encouraging figure, and we expect statistically significant results in Phase 3 as well."

Oregovomab is currently undergoing a global Phase 3 clinical trial based on promising Phase 2 results in newly diagnosed ovarian cancer patients, where progression-free survival (PFS) was 42 months, an increase of 30 months compared to the control group. As of February 7, 517 of the targeted 602 patients have been recruited.

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