New data for PV study
TAIPEI, Taiwan—Biopharmaceutical company PharmaEssentia Corp. recently presented its Phase 3 PROUD-PV study results for first-line treatment of polycythemia vera (PV), a blood cancer marked by elevated red blood cell production, at the 2016 American Society of Hematology Annual Meeting and Exposition. The study compared ropeginterferon alfa-2b (P1101), PharmaEssentia’s novel, long-acting, mono-pegylated interferon therapeutic, with hydroxyurea in PV patients. In a Phase 1/2 trial of P1101 in these patients, the overall clinical response rate including reduction of red and white blood cells and platelets was about 90 percent, and 45 to 50 percent of patients showed complete response after six to 12 months of treatment. In addition, all patients were largely independent from phlebotomies after one year. JAK2V617F has been identified as the key mutation in PV, and P1101 treatment significantly reduced the allelic burden of the mutated clone in patients.