The trial was designed to demonstrate survival benefit for patients treated with PHP after 28 days compared to placebo (+ standard care), and at day 60 and day 90 as secondary endpoints.
Following the review by an independent Data Monitoring Board (DMB) of the result of the Phoenix trial, they recommended that the overall safety profile of the company’s lead product PHP appears acceptable without signals or trends which might require modification or suspension of the trial.
Consequently, the pivotal study will be continued according to the plan.