CTI BioPharma Announces Positive Progress Of Its Lead Clinical Program

(RTTNews) - CTI BioPharma Corp. (CTIC) announced Monday positive progress of its lead clinical program in addition to several key business priorities for 2016.

In January 2016, CTI BioPharma announced the completion of the rolling New Drug Application to the U.S. Food and Drug Administration for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. CTI BioPharma and Baxalta Incorporated are seeking U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter.

James Bianco, CTI BioPharma's President and Chief Executive Officer, said, "After a productive 2015, we have entered 2016 well capitalized and focused on preparing for the potential accelerated approval and launch of a new treatment option for people with intermediate and high-risk myelofibrosis with low platelet counts. With the recently completed NDA submission for pacritinib, interim data indicating the potential therapeutic utility for tosedostat in AML and high-risk MDS, and a strong financial position, we believe the stage is set for a transformational year for our company."

CTI BioPharma said it plans to provide 2016 financial guidance in its fourth quarter and year-end 2015 financial results announcement.