logo
Plus   Neg
Share
Email

CTI BioPharma To Initiate PACIFICA Phase 3 Trial In Q3 - Quick Facts

CTI BioPharma Corp. (CTIC) said Thursday that it has completed a Type B, End-of-Phase-2a meeting with the U.S. Food and Drug Administration for the continued development of its investigational myelofibrosis treatment candidate, pacritinib.

Following this meeting, CTI now plans to evaluate 200 mg of pacritinib administered twice daily or BID in 180 patients with myelofibrosis and severe thrombocytopenia.

The company intends to initiate the Phase 3 PACIFICA study in the third quarter of 2019, putting it on track for topline Phase 3 data in mid-2021.

"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 Craig, President and Chief Executive Officer of CTI BioPharma.

The randomized, open-label Phase 2 PAC203 dose-finding study was designed to evaluate the safety and efficacy of three dosing regimens of oral pacritinib in 150 patients with myelofibrosis.

The company expects topline safety and efficacy results from the Phase 2 portion of the PAC203 study in the third quarter of 2019 and is targeting presentation of the Phase 2 results at a scientific conference before the end of 2019.

CTI is currently amending the protocol for the ongoing Phase 2 PAC203 study to include the new PACIFICA Phase 3 portion, in which it intends to compare the safety and efficacy of 200 mg of pacritinib administered twice daily to Physician's Choice in 180 myelofibrosis patients with severe thrombocytopenia at about 120 sites worldwide.

Patients will be randomized in a ratio of 2:1 between pacritinib and Physician's Choice. The primary endpoint of the trial is the percentage of patients who achieve at least 35 percent reduction in spleen volume at week 24.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
United Airlines has rolled out an interactive online "Map Search" feature for its customers in collaboration with search giant Google. The new feature is powered by Google Flight Search Enterprise Technology. United is claimed to be the first airline in the U.S. to add this feature. The new feature, available on United.com, allows customers to easily search, compare and purchase flight tickets. GHSW, LLC. is recalling Trader Joe's Southwest Style Sweet Potato Sauté Bowl citing undeclared milk and egg allergens in the dressing, according to the Food and Drug Administration. The recall was initiated after it was discovered that the dressing in the bowl contains milk and egg, but are not declared on the label. California Gov. Gavin Newsom signed an executive order on Wednesday that bans the sale of new gasoline-powered vehicles in the state by 2035. With this, California plans to phase out the sale of all gasoline-powered vehicles and to drastically reduce demand for fossil fuel in its fight against climate change. The order directs the California Air Resources Board to develop a plan.
RELATED NEWS
Follow RTT