Futility analysis in PLIANT study completed and approved by the DSMB, states Pledpharma.
The futility/safety analysis of the first 30 patients has been completed and that no negative impact on the anticancer effect of the chemotherapy drug has been observed.
The analysis covers the first 30 patients in the study who have completed four treatment cycles with the chemotherapy mixture FOLFOX after pretreatment with either PledOx or placebo. The analysis showed that PledOx did not weaken the anticancer effect of FOLFOX. The analysis was conducted and approved by the independent expert panel DSMB (Drug Safety and Monitoring Board). The PLIANT trial can thus proceed with recruitment of patients as planned.
“The safety analysis is important since there has been a concern that the PledOx drug may not only protect healthy cells but also cancer cells against the effects of chemotherapy. The DSMB has therefore had an extra focus on this during the analysis but no negative impact on the anti-cancer effect of the chemotherapy drug has been observed,” says CEO Jacques Näsström.
Safety analyzes will be conducted after every additional 30 patients have undergone four treatment cycles with chemotherapy, after pretreatment with either PledOx or placebo.