PledOx® (calmangafodipir) is a “first-in-class” drug candidate, designed to prevent nerve damage caused by chemotherapy without reducing its anticancer effects. The phase III program was prematurely stopped in the second quarter 2020. In December 2020 Pledpharma announced that PledOx® did not meet the efficacy endpoint in the prematurely closed Phase 3 POLAR program. The occurrence and type of adverse events observed were generally consistent with the expected toxicity caused by the chemotherapy and the patient populations studied. Based on further evaluation of the results from the POLAR studies, the strategic next steps for PledOx® will be determined together with Solasia.



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