The Food and Drug Administration has shut down Seattle-based CTI BioPharma’s clinical trial of a blood cancer drug after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
The Food and Drug Administration has shut down Seattle-based CTI BioPharma’s clinical trial of a cancer-drug candidate after patients died of cardiac arrest and bleeding inside the skull.
CTI BioPharma, which was previously known as Cell Therapeutics, started testing the drug called pacritinib in December 2013 as a treatment for myelofibrosis, a blood cancer, and other cancers.
The FDA initially put a partial hold on the Phase 3 clinical trial last week, requiring CTI to halt new patient enrollment. The company announced late Tuesday the FDA had put the trial on full clinical hold after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
All patients on pacritinib must stop the drug, and no new patients can be added to the trial, the company said in a news release.
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CTI gave no details on the number of deaths associated with the clinical trial. Spokeswoman Monique Greer said Wednesday that an earlier Phase 3 trial had 327 patients and the current one had more than 300 patients.
She said the company, which has withdrawn the new-drug application under which it was conducting the clinical trial to gain marketing approval for pacritinib, was “not in a position to make any public statements regarding next steps at this time” because it is still working with the FDA.
CTI was the subject of a 2013 Seattle Times investigation about its first commercial drug, Trisenox. The company was sued by the U.S. Department of Justice in 2010 for illegally promoting the drug for unapproved uses. CTI eventually paid the federal government $10.5 million to settle the suit.
The company noted in its 2014 annual report that the first Phase 3 trial of pacritinib has “positive top-line results” and the FDA had fast-tracked the second part of the phase 3 trial, which was to target patients with intermediate and high-risk myelofibrosis.
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.”
Any kind of severe effect during a trial must be reported to the FDA, Gortler said, and companies usually shut down trials themselves after deaths occur.
The company’s statement said the FDA’s Monday letter cited interim results from the clinical trial that “show a detrimental effect on survival.” The clinical trial was comparing pacritinib to “the best available” current treatment for patients with myelofibrosis.
Kevin Noonan, a biotechnology patent lawyer with McDonnell Boehnen Hulbert & Berghoff in Chicago and a former molecular biologist, said Phase 3 trials are the culminating stage of testing for the drug.
“Many, many compounds can get through the first couple phases, then fail in Phase 3.”
He compared the process to safety testing a car — you want to drive it as fast as you can because you want to make sure you have tested every aspect.
Entering a new phase is like turning a blind corner, he said.
He noted that the FDA errs on the side of safety by placing blame on the drug for the death, though occasionally the cause turns out to be something else.
Shares of CTI BioPharma fell 40 percent to 30 cents on Wednesday. Combined with a sharp plunge Tuesday on the earlier news of the partial clinical hold, the stock is down about 75 percent this week.
James Bianco remains at the helm of the company founded in 1991.
During a quarter century, it has raised and spent more than $2 billion, according to its latest quarterly report in November. In December, it raised about $50 million more.
But at its current share price, CTI BioPharma’s total market capitalization is only about $92 million.