SEATTLE, June 11, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced the upcoming presentation of data highlighting PIXUVRI (pixantrone), the first approved treatment in the European Union for aggressive B-cell non-Hodgkin lymphoma (NHL) for adult patients who have failed 2 to 3 prior lines of therapy, and results from a pooled analysis of data from completed Phase 1 and 2 studies of pacritinib, a novel, oral JAK2/FLT3 inhibitor, at the 18th Congress of the European Hematology Association (EHA) Annual Meeting, June 13-16, 2013 in Stockholm, Sweden.
"At EHA, we plan to present further analyses of the final safety and efficacy data from our EXTEND pivotal trial of PIXUVRI that we believe expand our understanding of the potential clinical benefit for patients with aggressive B-cell NHL who had received 2 to 3 prior regimens," said Jack Singer, M.D., Executive Vice President, Global Medical Affairs and Translational Medicine at CTI. "In addition, at EHA, results from a pooled integrated safety analysis from four Phase 1 and 2 clinical trials will be presented that quantify clinical toxicities of pacritinib, our novel, oral JAK2/FLT3 inhibitor currently being investigated in a Phase 3 clinical program."
Information regarding the EHA presentations is below. Full abstracts can be viewed at the EHA website.
Abstract Number: P310 Poster Title: Pixantrone monotherapy in histologically confirmed, relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: Post-hoc analyses from a Phase 3 trial Presentation Date/Time/Location: Friday, June 14, 5:45 to 7:00 p.m. CEST, Poster Hall First Author: Dr. Ruth Pettengell, St. George's Hospital, London, United Kingdom
Abstract Number: P278 Poster Title: Safety overview of phase I-II studies of pacritinib, a non-myelosuppressive JAK2/FLT3 inhibitor, in patients with hematological malignancies Presentation Date/Time/Location: Friday, June 14, 5:45 to 7:00 p.m. CEST, Poster Hall First Author: Dr. S. Verstovsek, MD Anderson Cancer Center, Houston, United States
Abstract Number: P983 Poster Title: Characterization of the pharmacokinetic and pharmacodynamic properties of pacritinib, a novel oral JAK2/FLT3 inhibitor, in patients with myelofibrosis, AML and lymphoma Presentation Date/Time/Location: Poster session, Saturday, June 15, 5:45 to 7:00 p.m. CEST, Poster Hall First Author: Dr. Suliman Al-Fayoumi, Cell Therapeutics, Seattle, United States
About PIXUVRI (pixantrone)
PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds,PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.
InMay 2012, the European Commission granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressiveNHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. TheSmPCis available atwww.pixuvri.eu. CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. PIXUVRI does not have marketing approval inthe United States.
About Pacritinib
Read more:
CTI Announces Data Presentations at the 18th Congress of the European Hematology Association
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