CTI: Pacritinib End Trial For Advanced Myelofibrosis Met One Of Co-primary Goals

(RTTNews) - CTI BioPharma Corp. (CTIC) announced Monday that PERSIST-2, a randomized, controlled Phase 3 clinical trial of Pacritinib for high-risk patients with Advanced Myelofibrosis met one of the co-primary endpoints.

Preliminary results demonstrated statistically significant improvement in spleen volume reduction or SVR with pacritinib, an investigational oral multikinase inhibitor, compared to physician-specified best available therapy or BAT, including ruxolitinib, for the treatment of patients with myelofibrosis whose platelet counts are less than 100,000 per microliter -- a patient population with high-risk advanced disease.

Although the PERSIST-2 trial did not meet the other co-primary endpoint of greater than 50 percent reduction in Total Symptom Score, the preliminary analysis approached marginal significance compared to BAT, the company noted.

The most common treatment emergent adverse events for pacritinib were generally manageable diarrhea, nausea and vomiting. The incidence of cardiac and bleeding adverse events were similar across the arms. Overall mortality rates were comparable between arms.

The company noted that additional data from ongoing analyses along with top-line results from PERSIST-2 will be submitted for presentation at an upcoming scientific meeting.