Deaths Stop Clinical Trials of Cancer Drug

SEATTLE (CN) – The Food and Drug Administration has stopped clinical trials of a Seattle company’s blood cancer treatment pacritinib due to patient deaths.
     The U.S. FDA imposed a partial clinical hold on CTI BioPharma’s clinical trial on Feb. 4, then stopped the trials completely on Feb. 8.
     Neither the FDA nor CTI Biopharma said how many patients have died.
     Patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest” after taking pacritinib, an investigative drug for treatment of myelofibrosis, CTI said in a statement on Feb. 9.
     The FDA cannot comment due to disclosure laws regarding investigational drugs, according to FDA press officer Sarah Peddicord.
     All patients taking pacritinib must discontinue the drug immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment.
     CTI “has withdrawn its New Drug Application (NDA) until the company has had a chance to review the safety and efficacy data from the PERSIST-2 Phase 3 clinical trial and decide next steps,” the company said in the statement.
     The clinical trials began in 2013 and were designed for 300 participants.
     The price of CTI shares fell by 45 percent on Wednesday, according to financial news website Benzinga.
     CTI BioPharma changed its name from Cell Therapeutics in 2014.
     In 2007, Cell Therapeutics paid $10 million to settle government claims it paid illegal kickbacks to doctors for promoting its cancer drug Trisenox for off-label use.

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