New Drug Application for SB 1518 (pacritinib) for myelofibrosis withdrawn after FDA announces clinical hold on trials- CTI BioPharma

Following the partial clinical hold announced in February 2016 by the FDA regarding its clinical studies of SB 1518 (pacritinib) for myelofibrosis, CTI BioPharma received communication from the FDA notifying the Company that its IND for pacritinib has been placed on full clinical hold. The Company has withdrawn its New Drug Application (NDA) until the Company has had a chance to review the safety and efficacy data from the PERSIST-2 Phase III clinical trial and decide next steps. The FDA's letter notes the interim overall survival results from PERSIST-2 show a detrimental effect on survival consistent with the results from PERSIST-1.

The deaths in PERSIST-2 in pacritinib-treated patients include intracranial haemorrhage, cardiac failure and cardiac arrest. The FDA made recommendations that supersede those made in connection with the partial clinical hold imposed in February 2016. The current recommendations include conducting dose exploration studies for pacritinib in patients with myelofibrosis, submitting final study reports and datasets for PERSIST-1 and PERSIST-2, providing certain notifications, revising relevant statements in the related Investigator's Brochure and informed consent documents and making certain modifications to protocols. In addition, the FDA recommended that the Company request a meeting prior to submitting a response to full clinical hold.