In a move for the prevention of loss of lives, the Food and Drug Administration has shut down Seattle-based CTI BioPharm's clinical trial of a cancer drug after patients died of cardiac arrest and internal bleeding.
CTI BioPharma, which was previously known as Cell Therapeutics, started testing of the drug named pacritnib in December 2013 as a treatment for myelofibrosis, a type of blood cancer, according to The Seattle Times.
FDA had initially put a partial hold on the Phase 3 clinical trial prior to last week, which required CTI to hold patent enrollment. However, the company announced last Tuesday that FDA had put the trial on full clinical hold after the death of the patients from "intracranial hemorrhage, cardiac failure and cardiac arrest."
Although CTI divulged no details on the number of patients who have died from the drug, yet the company spokesperson, Monique Greer mentioned on last Wednesday that the earlier Phase 3 trial had 327 enrolled patients and the current one had more than 300 enrolled patients.
She also mentioned that the company was "not in a position to make any public statements regarding next steps at this time" because it was still working with the FDA.
Notably, according to company's annual report of 2014, the first Phase 3 trial of pacritinib had "positive top - line results".
Drug trials often fail during Phase 3 trials, but it is generally not because of multiple deaths, said David Gortler, a former FDA senior medical officer and a drug-safety expert at consulting group FormerFDA.com.
"Patient deaths are a rare occurrence, generally speaking, within clinical trials," Gortler said. "Even one death is cause enough to shut down a clinical trial."
However, any death or severe effect must be reported to FDA and the companies generally shut down trials on their own after the death occurs.
Consequently, shares of CTI BioPharma had seen a rapid decrease after the incident and saw a deep plunge on last Tuesday.
