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# FDA Lifts Hold on CTI BioPharma Myelofibrosis Drug Trial
- URL: https://www.fdaweb.com/fda-lifts-hold-on-cti-biopharma-myelofibrosis-drug-trial/
- Published: 2017-01-06T12:00:00.000Z
- Updated: 2026-09-14T21:58:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137654

FDA has lifted a full clinical hold on CTI BioPharma’s pacritinib for treating myelofibrosis. The hold was ordered 2/2016 due to excess mortality and other adverse events in pacritinib-treated patients compared to the control arm in the PERSIST-1 trial.  
  
CTI submitted a complete response submission ([see company release](http://investors.ctibiopharma.com/phoenix.zhtml?c=92775&p=RssLanding&cat=news&id=2234163&ref=fdaweb.com)) to have the hold lifted that included, among other items, final clinical study reports for both PERSIST-1 and 2 trials and a dose-exploration clinical trial protocol that FDA requested. The new trial, PAC203, plans to enroll up to 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 company expects to start the trial in the second quarter.