SEATTLE, March 10, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced the final clinical trial design of a randomized pivotal trial of pixantrone for the treatment of diffuse large B-cell lymphoma ("DLBCL") following discussions with the U.S. Food and Drug Administration's (the "FDA") Division of Hematologic Products (the "DHP") . The new clinical trial, referred to as the PIX-R or PIX 306 trial, will compare a combination of pixantrone plus rituximab to a combination of gemcitabine plus rituximab in patients with relapsed or refractory DLBCL who have received one to three prior lines of therapy, utilizing progression free survival ("PFS") and Overall Survival ("OS")as co-primary endpoints of the study. The PIX-R trial, is targeting to enroll approximately 350 patients over 18 months and will include patients who have failed at least one line of previous therapy and patients who are not candidates for myeloablative chemotherapy and stem cell transplant. During its discussions with the DHP the Company was advised that only OS would be acceptable for a formal Special Protocol Assessment ("SPA") agreement, however the DHP noted that the Company could conduct a study utilizing PFS along with OS as co-primary endpoints which would be an acceptable design outside of the formal SPA process. Regulatory acceptability will depend on the magnitude of the difference between the trial study arms as well as a risk and benefit analysis.
"CTI has worked with the DHP since August on an appropriate clinical trial design that may serve as either a post-marketing commitment trial or as a follow-on pivotal trial depending on the outcome of an appeal of CTI's new drug application for pixantrone based on the PIX 301 trial at the FDA's Office of New Drugs," stated James A. Bianco, M.D., CEO of Cell Therapeutics.
"We believe that pre-clinical data and results from a randomized clinical trial have already demonstrated syn
|SOURCE Cell Therapeutics, Inc.|
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