Muparfostat: Interim Phase III data

Interim data from the double-blind, Asian Phase III PATRON trial in about 500 patients with hepatitis virus-related HCC showed that adjuvant treatment with 160 mg subcutaneous PI-88 on days 1-4 of the first 3 weeks of 4-week cycles after surgical resection missed the primary endpoint of improving DFS vs. placebo. PI-88 was safe. An independent committee performed the interim analysis after the occurrence of the first 131 events, defined as tumor recurrence or death from any cause.

Medigen is continuing the trial, with final data expected next year. Additionally, Progen said the independent committee will perform further analysis when imaging data are available. ...