CanariaBio "60% of Global Phase 3 Clinical Trial Patient Recruitment Completed"

[Asia Economy Reporter Jang Hyowon] Canaria Bio announced on the 21st that patient recruitment for the global Phase 3 clinical trial of Oregovomab, conducted on ovarian cancer patients, has reached 60% completion.

The target number of patients is 602. This global Phase 3 clinical trial is divided into two cohorts: adjuvant chemotherapy and neoadjuvant chemotherapy. The FDA has indicated that approval of the new drug is possible if either one of the cohorts is successful.

With the recent addition of sites in Brazil and India, where neoadjuvant chemotherapy is more commonly used, the company expects to complete patient recruitment for the cohort combining Oregovomab with neoadjuvant chemotherapy by the end of the year.

For the cohort adding Oregovomab to adjuvant chemotherapy, patient recruitment is expected to be completed by the first quarter of next year. As patient recruitment has surpassed 60% of the target, the company explained that the interim results announcement is likely to be possible in the third quarter of next year as originally planned.

Canaria Bio had planned to recruit patients at 130 sites across 16 countries, but recruitment was delayed due to COVID-19. To compensate, the company announced measures to add up to 40 additional sites. Currently, a total of 152 sites across 16 countries have been opened.

Oregovomab showed encouraging results in the global Phase 2 clinical trial, with progression-free survival (PFS) extended by 30 months compared to the existing standard treatment, reaching 42 months. The p-value for overall survival (OS) was 0.004, and the p-value for progression-free survival (PFS) was 0.002. It was also recommended as the most promising new drug among immuno-oncology agents targeting ovarian cancer by the oncology specialist site 'OncoLive.'

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