FDA shuts down CTI Bio's pacritinib clinical trials; shares down 46% premarket

Feb. 09, 2016 9:59 PM ETCTI BioPharma Corp. (CTIC)CTICBy: Douglas W. House, SA News Editor15 Comments
  • After reviewing interim overall survival data in CTI BioPharma's (NASDAQ:CTIC) PERSIST-2 clinical trial assessing lead product candidate pacritinib, the FDA has informed the company that its Investigational New Drug (IND) application has been placed on full clinical hold. The basis for the decision was a similar detrimental effect on survival in PERSIST-2 that was observed in PERSIST-1.
  • The deaths in PERSIST-2 include intracranial hemorrhage, cardiac failure and cardiac arrest.
  • Full clinical hold means that no new patients can be recruited for the trials and all currently enrolled patients taking pacritinib must cease immediately. The company has withdrawn its New Drug Application (NDA), completed a month ago, until it has had the time to thoroughly review the data in PERSIST-2.
  • The agency's current recommendations include conducting dose exploration studies of pacritinib in patients with myelofibrosis, submitting final study reports and datasets for both PERSIST trials, providing certain notifications, revising certain statements in the investigator's brochure and informed consent documents and modifying the protocols.
  • The FDA has recommended to the company that it request a meeting prior to submitting a response to full clinical hold.
  • Shares are down 46% premarket on robust volume.
  • Previously: FDA places clinical studies of CTI Bio's lead product candidate on partial clinical hold due to excess mortality; shares drop 27% premarket (Feb. 8)

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