CTI to start Phase 3 for myelofibrosis med in Q3

CTI BioPharma Corp. (Nasdaq: CTIC) (‘CTI’ or ‘the Company’) today announced the outcome of a Type B, End-of-Phase-2a meeting with the U.S. Food and Drug Administration (‘FDA’ or ‘the Agency’) for the continued development of its investigational myelofibrosis treatment candidate, pacritinib.

Following this meeting, CTI plans to evaluate 200 mg of pacritinib administered twice daily (BID) in 180 patients with myelofibrosis and severe thrombocytopenia. The Company plans to initiate the Phase 3 PACIFICA study in the third quarter of 2019.

‘We are pleased to be able to move the pacritinib program forward and are now in the process of finalizing an amendment to the PAC203 protocol, which the FDA will review, to allow a transition to the new PACIFICA Phase 3 study, in which we plan to compare the 200 mg BID dose of pacritinib to Physician’s Choice in myelofibrosis patients with severe thrombocytopenia, an important unmet medical need,’ said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. ‘We anticipate initiating the trial in the third quarter, which would put us on track for topline Phase 3 data in mid-2021.’

https://www.marketscreener.com/CTI-BIOPHARMA-CORP-32713095/news/CTI-BioPharma-Announces-Outcome-from-End-of-Phase-2a-Meeting-With-U-S-Food-and-Drug-Administratio-28929664/