EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that the targeted enrollment in a Phase IIb trial for EpiCept™ NP-1 in chemotherapy-induced peripheral neuropathy (CPN) has been attained. The trial is being conducted by National Cancer Institute (NCI)-funded Community Clinical Oncology Program. EpiCept™ NP-1 is a patented topical cream formulation of two FDA- approved drugs, 4% amitriptyline and 2% ketamine, and is intended to provide long-term relief from the pain of peripheral neuropathies. CPN may affect 50% of women undergoing treatment for breast cancer.
The double-blind, randomized placebo-controlled study has enrolled more than 400 patients suffering from painful CPN for at least 28 days following the conclusion of chemotherapy. The primary endpoint of the 6-week trial is change in average daily neuropathy intensity scores from baseline to the endpoint. Secondary endpoints include the percentage of patients whose neuropathy intensity decreases at least 30% from baseline as well as various other measures. Topline data is expected to become available by year end.