CanariaBio said the Data and Safety Monitoring Board (DSMB) recommended halting its global phase 3 clinical trial of oregovomab, an antibody targeting CA125, for ovarian cancer patients.

The company said that the recommendation was made due to the trial not achieving the necessary statistical value (p-value) in the futility analysis.

The phase 3 trial involved over 610 ovarian cancer patients and compared the combination therapy of oregovomab and chemotherapy (carboplatin + paclitaxel) with chemotherapy alone in a first-line treatment setting. The trial took place in the U.S., Argentina, Belgium, Canada, the Czech Republic, Hungary, India, Korea, Mexico, Spain, and Taiwan. 

However, the DSMB advised continuing to monitor overall survival (OS).

“We will analyze the reasons behind the results that contradicted our phase 2 studies and plan our future accordingly,” CanariaBio CEO Na Han-ik said.

This comes as a letdown for CanariaBio because oregovomab had garnered attention from investors when it was designated an orphan drug in Europe.

However, following the news of the trial's halt, the company's stock price hit the lower limit for two consecutive days and plunged by 29.9 percent to 2,480 won ($1.85) at the start of trading on Thursday.