CTI BioPharma Corp (NASDAQ:CTIC) announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studies being conducted under the Company’s Investigational New Drug (“IND”) application for pacritinib. This clinical hold impacts part of the clinical work currently being conducted under the IND and will also affect planned clinical trials.
Under the partial clinical hold, clinical investigators may not enroll new patients or start pacritinib as initial or crossover treatment, and patients not deriving benefit after 30 weeks of pacritinib treatment should stop using pacritinib. In addition, the FDA has recommended that the Company make certain modifications of protocols, including modifying all protocols for randomized trials to disallow crossover to pacritinib, provide certain notifications, revise relevant statements in the related investigator’s brochure and informed consent documents, and take certain other actions. The Company intends to implement the FDA’srecommendations. All clinical investigators worldwide have been delivered a notice of the partial clinical hold.
The Company intends to work together with the FDA and expects to submit modifications and revisions that address the recommendations noted above. In its written notification, the FDAcited the reasons for the partial clinical hold were that there was excess mortality and other adverse events in pacritinib-treated patients compared to the control arm in the PERSIST-1 trial. The excess mortality was most evident during the non-randomized crossover period following the initial 24 weeks of randomized treatment, during which patients in the control arm could switch to pacritinib treatment. In prior correspondence, the FDA acknowledged the difficulty addressing non-significant results, and that crossover designs can confound the interpretation of safety as well as the evaluation of survival.
After submission of the required information, the FDA has indicated that it would notify the Company whether it can continue the clinical studies under the IND. (Original Source)
Shares of CTI BioPharma are down nearly 55% in pre-market trading. CTIC has a 1-year high of $2.94 and a 1-year low of $0.80. The stock’s 50-day moving average is $1.21 and its 200-day moving average is $1.43.
On the ratings front, CTI BioPharma has been the subject of a number of recent research reports. In a report issued on January 5, Piper Jaffray analyst Charles Duncan reiterated a Buy rating on CTIC, with a price target of $8, which represents a potential upside of 614.3% from where the stock is currently trading. Separately, on November 9, WallachBeth Capital LLC’s Bob Ai downgraded the stock to Hold and has a price target of $1.60.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Charles Duncan and Bob Ai have a total average return of -8.8% and -16.1% respectively. Duncan has a success rate of 26.1% and is ranked #3362 out of 3584 analysts, while Ai has a success rate of 20.0% and is ranked #3091.