FDA halts clinical trial of CTI Biopharma’s blood cancer drug

The hold comes as a result of the deaths that have occurred during the experimental trial. Patients have reportedly died of cardiac arrest and bleeding inside the skull.

The number of deaths has not been reported. The current trial phase had more than 300 patients and the previous trial phase had about 337 patients.

CTI received a communication from FDA that it had placed Pacritinib on partial hold on the clinical studies being conducted under the company’s Investigational New Drug (IND) application for Pacritinib.

The company said that it has withdrawn its application for the experimental drug. It will now review the safety and efficacy of the drug.

Under the hold, clinical investigators may not enroll new patients or start Pacritinib as initial or crossover treatment and also patients who do not receive any benefit after 30 weeks of Pacritinib treatment should stop using it.

Prior to this, CTI came under an investigation when its arsenic-based medicine intended for a very rare kid of blood cancer (acute promyelocytic leukemia).

Previously, FDA had ordered partial halt on the drug on 4th February following deaths.

CTI BioPharma had announced earlier this month that it has completed patient enrollment in the PERSIST-2 Phase 3 clinical trial of pacritinib for the treatment of patients with myelofibrosis.