CTI BioPharma Corp. (CTI BioPharma) announced (January 5th 2017) that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold (implemented in February 2016) on all clinical trials using the drug pacritinib.
Pacritinib is a drug aimed at myelofibrosis but was placed on full clinical hold by the FDA due to safety concerns. In their press release, CTI BioPharma announced that a new trial, PAC203, will enroll up to approximately 105 patients with primary myelofibrosis who have failed prior ruxolitinib therapy to evaluate the safety and the dose response relationship for efficacy (spleen volume reduction at 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in PERSIST-2. The trial is expected to start in the second quarter of 2017.