The U.S. Food and Drug Administration ceased clinical trials for a CTI BioPharma cancer drug this week after several participants died from its side effects.
The FDA notified the Seattle-based pharmaceutical company on Feb. 8 that it placed a full hold on the clinical trial for its pacritinib drug. Patients died from hemorrhage, cardiac failure and cardiac arrest after taking the medication, according to a news release.
Pacritinib had two Phase 3 clinical trials. One trial had 327 participants, and the other had more than 300, said Monique Greer, a CTI BioPharma spokeswoman.
The drug was used for the treatment of certain cancers, including the blood cancer myelofibrosis.
All patients using pacritinib were told to stop and the FDA has removed it from its new drug application process.
In its notification to CTI BioPharma, the FDA suggested that it study dosage recommendations for pacritinib, and that the company meet with the agency before submitting a response to the full hold.
Greer said CTI BioPharma intends to follow the FDA's suggestions.
The decision comes after the FDA placed a partial hold on the drug last week for “excessive mortality” among patients participating in the Phase 3 trial. A partial hold prevents any new patients from participating in the trial.
This is not the first time CTI BioPharma has been under fire. In 2007, the U.S. Justice Department sued CTI BioPharma for marketing unapproved uses for its leukemia drug Trisenox. BioPharma paid $10.5 million to settle the suit.
CTI BioPharma stock has plunged since the hold was placed, from $1.40 a share on Feb. 4 to 31 cents a share Thursday. The company is valued at $89.6 million.
