PledOx® (calmangafodipir) is a “first-in-class” drug candidate, designed to prevent nerve damage caused by chemotherapy without reducing its anticancer effects. A Phase III trial has commenced.
The results from a completed Phase IIb trial (PLIANT) in patients with metastatic colorectal cancer who were treated with the chemotherapy combination of FOLFOX, show that those individuals who received PledOx® were at lower risk of damage to peripheral nerves than the placebo group. PledOx® showed 38% effect (odds ratio = 0.62; p=0.16) on investigator-reported peripheral neuropathy (the primary endpoint) compared with the placebo group. This was not statistically significant, but a difference of this magnitude is considered clinically important. When following up the chemotherapy treatment, PledOx® showed 77% effect (odds ratio = 0.23; exploratory analysis: p=0.014) on patient-reported moderate and severe neuropathy compared with the placebo. This is considered valuable for the likelihood of succeeding with the forthcoming POLAR trials, where patient-reported symptoms after completed treatment will be the primary endpoint. No apparent adverse impact on the anticancer effects of the chemotherapy was observed with PledOx®.