CTI BioPharma Corp (NASDAQ:CTIC) announced that the full clinical hold (February 2016) implemented by the U.S. Food and Drug Administration (FDA) on all clinical trials conducted under the Investigational New Drug (IND) application for pacritinib has now been removed.
The Company’s complete response submission included, among other items, final Clinical Study Reports for both PERSIST-1 and 2 trials and a dose-exploration clinical trial protocol that the FDA requested. The new trial, PAC203 plans to enroll up to approximately 105 patients with primary myelofibrosis who have failed prior ruxolitinib therapy to evaluate the safety and the dose response relationship for efficacy (spleen volume reduction at 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in PERSIST-2. The Company expects to start the trial in the second quarter of 2017.
“We are pleased to resolve the full clinical hold through working diligently with the FDA to provide a comprehensive response to their requests,” said Richard Love, Interim President and CEO of CTI BioPharma. “We look forward to discussing with the FDA the future development of pacritinib. We believe pacritinib can ultimately address the unmet need of patients with myelofibrosis who are ineligible to receive or are not benefitting from the approved JAK1/JAK2 inhibitor, ruxolitinib, as these patients have limited treatment options.” (Original Source)
Shares of CTI BioPharma are rising 18.39% to $4.70, up $0.73 in pre-market trading Thursday. CTIC has a 1-year high of $4.22 and a 1-year low of $3.87. The stock’s 50-day moving average is $0.65 and its 200-day moving average is $0.44.
CTI BioPharma Corp. operates as a biopharmaceutical company, which is focused on the acquisition, development, and commercialization novel targeted therapies covering a spectrum of blood-related cancers. Its products include Pixuvri, Pacritinib, Tosedostat and Opaxio.