Health and Healthcare

CTI BioPharma Stumbles Over Full Clinical Hold

Chris Lange

Published: February 10, 2016 1:20 pm

Last Updated: January 13, 2020 1:21 pm

CTI BioPharma Corp. (NASDAQ: CTIC) has practically become a penny stock overnight following an update from its Investigational New Drug (IND) application for pacritinib. The update basically states that the U.S. Food and Drug Administration (FDA) has placed pacritinib on a full clinical hold.

As a result, the company has withdrawn its New Drug Application (NDA) until it has had a chance to review the safety and efficacy data from the Persist-2 Phase 3 clinical trial and decide next steps.

Also under the full clinical hold, all patients currently on pacritinib must discontinue it immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment.

CTI detailed in its release:

The FDA’s February 8, 2016, 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 hemorrhage, cardiac failure and cardiac arrest. The FDA made recommendations that supersede the recommendations made by the FDA in connection with the partial clinical hold imposed by the FDA on February 4, 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.

Shares of CTI were trading down 42% at $0.29 on Wednesday, with a consensus analyst price target of $4.28 and a 52-week trading range of $0.25 to $2.94.