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Cell Therapeutics Initiates Pixantrone PIX-R Pivotal Trial for Treatment of Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Date:3/20/2011

ding on the outcome of a formal appeal that CTI submitted to the Food & Drug Administration's (the "FDA") Office of New Drugs in the FDA's Center for Drug Evaluation and Research in December 2010 regarding its 2010 decision about CTI's new drug application (the "NDA") for pixantrone. The NDA for pixantrone was based on the results of the PIX 301 trial, a randomized trial comparing pixantrone as monotherapy to a choice of standard single-agent chemotherapy in relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL") patients. CTI expects a decision regarding its appeal in the second quarter of 2011.

PIX-R TRIAL Design

The PIX-R trial is designed to be a randomized, multicenter study comparing pixantrone plus rituximab to gemcitabine plus rituximab in patients with relapsed or refractory DLBCL or DLBCL transformed from follicular lymphoma who have received one to three prior lines of therapy, including CHOP-R or an equivalent regimen. The patients to be enrolled in the PIX-R trial cannot be eligible for high-dose (myeloablative) chemotherapy and stem cell transplant, but patients who relapse after such a procedure are eligible. The co-primary endpoints for the PIX-R trial are PFS and OS with secondary endpoints including overall response rate ("ORR") (ORR equals complete responses plus partial responses), complete response rate and safety.  CTI is targeting to enroll 350 patients over 18 months in the PIX-R trial.

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II, but unlike anthracyclines, rather than intercalation with DNA, pixantrone alkylates DNA and forms stable DNA adducts with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymph
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SOURCE Cell Therapeutics, Inc.
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