Posted by Michael Wonder on 02 Nov 2018
Constellation Pharmaceuticals receives FDA fast track designation for CPI-0610 in treatment of myelofibrosis
1 November 2018 - Recently expanded and enhanced MANIFEST Phase 2 trial on-going with proof of concept data expected mid-2019.
Constellation Pharmaceuticals today announced that it has received fast track designation from the United States FDA for CPI-0610 in treatment of myelofibrosis (MF) based on preliminary results from the Company’s Phase 2 study, MANIFEST.
Constellation is developing CPI-0610 with the goal of providing a new treatment option for patients with MF who have experienced disease progression after treatment with Jakafi (ruxolitinib), the only approved therapy for MF. Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial, which is exploring CPI-0610’s potential both as a monotherapy and as a combination therapy with Jakafi.
