Policy & Regulation
CanariaBio reaches 50% target enrolment for Phase III clinical study of oregovomab to treat front-line advanced ovarian cancer
30 June 2022 -

CanariaBio Inc., a South Korea-based company developing biotechnology assets through its subsidiaries, MH C&C and OncoQuest Pharma US Inc, announced on Wednesday that it has reached 50% of its target enrolment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy (carboplatin and paclitaxel) intended to treat front-line advanced ovarian cancer patients.

Presently, the double blind and placebo controlled multinational trial (FLORA-5, GOG-3035, NCT04498117) is accruing patients at more than 137 centres in Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Hungary, Italy, Korea, Mexico, Poland, Spain, Taiwan and US; with additional sites in India and Romania being activated. This study aims to confirm the observations of Brewer et al (Gynecology Oncology 2020 156:523-529) that showcased oregovomab in combination with carboplatin and paclitaxel improved both progression free and overall survival relative to chemotherapy, which was statistically significant and clinically meaningful in the absence of incremental toxicity.

Dr Sunil Gupta MBBS, FRCPC, OncoQuest Pharma US, Inc. (a subsidiary of CanariaBio Inc.) chief medical officer, said, 'We are excited about reaching this important milestone, which is a testament of the hard work that all our investigators, GOG leadership, team members and collaborators has put in, and are grateful to the patients that have participated in the study. We remain on track with our projected enrolment, and we are excited about the potential benefits that our drug may bring to patients with ovarian cancer.'