FDA Puts CTI BioPharma, Baxalta PERSIST-2 Trial on Partial Hold

Source: Business Finance News

Feb 09, 2016

U.S. regulators have issued a "partial clinical hold" on the CTI BioPharma and Baxalta PERSIST-2 Phase 3 clinical trial of pacritinib.

The main reason for suspending the clinical trial was the increase in mortality rate, as well as the side effect profile, compared with the control arm, in patients treated with pacritinib in the PERSIST-1 trial. The trial was suspended after investigators received a letter from the U.S. Food and Drug Administration (FDA) Feb. 4, 2016.

According to Business Finance News, the clinical hold will affect clinical work, as well as the clinical trial globally. Investigators will not be able to start new studies or enroll new patients. Also, the patients currently part of a trial will stop taking the drug after 30 weeks if an improvement in symptoms or decreased progression of the disease is not recorded.

On Feb. 3, 2016, CTI BioPharma Corp. announced the completion of enrollment in the PERSIST-2 Phase 3 clinical trial of pacritinib. PERSIST-2 was aimed at evaluating the safety profile, as well as the efficacy of pacritinib, in patients with myelofibrosis.

The prevalence of the disease in the U.S. ranges from 3.6 to 5.7 cases per 100,000 patients, noted Business Finance News.

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