Fingolimod for treatment and or prevention of chemotherapy-induced peripheral neuropathy in humans?

Abstract

AbstractPurposeSubstantial preclinical data support that fingolimod, a drug that dysregulates sphingolipid metabolism, could both prevent chemotherapy-induced neuropathy (CIPN) and treat established chemotherapy-induced neuropathy.MethodsTwo pilot-phase clinical trials were developed to evaluate whether fingolimod could 1) inhibit the development of paclitaxel-induced peripheral neuropathy and 2) diminish established CIPN in humans.ResultsUnfortunately, both clinical trials were not able to fulfill planned accrual goals. One of the major accrual problems was the requirement for patients to be in the clinic for 8 hours following their first oral dose of fingolimod. The prevention of paclitaxel CIPN trial accrued 2 patients, one of whom did very well without any significant CIPN while the other patient developed CIPN that led to early paclitaxel dose cessation. The treatment of established CIPN trial accrued 7 of 10 planned patients. The results from the 6 patients who started daily treatment with fingolimod did not suggest that it substantially decreased CIPN over what might have been expected from a placebo effect.ConclusionFingolimod is a clinically difficult treatment for patients to start and the limited clinical data from these protocols did not support that it was able to prevent CIPN or treat established CIPN.