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CTI BioPharma’s Pacritinib Meets One Co-Primary Endpoint, Just Misses Another, In PERSIST-2

 
• By John Davis

The US company is encouraged by top-line efficacy Phase III results showing pacritinib was effective in high-risk myelofibrosis patients with low platelet counts, and has said it is working with the FDA to lift the clinical hold imposed earlier this year because of side-effect concerns.

CTI BioPharma Corp. has been able to analyze top-line efficacy results from around a third of patients with myelofibrosis and thrombocytopenia enrolled in the PERSIST-2 Phase III study, treated before the FDA-imposed clinical hold came into effect in February, that show pacritinib met one of the co-primary endpoints of the study, and narrowly missed meeting the second.

The analysis gives some encouragement to the Seattle, Washington-based company that has been under a cloud since the FDA issued...

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