Cell Therapeutics Initiates Pixantrone PIX-R Pivotal Trial For Treatment Of Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

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BlankCell Therapeutics Initiates Pixantrone PIX-R Pivotal Trial For Treatment Of

Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

21 Mar 2011

Cell Therapeutics, Inc. ( " CTI " ) (Nasdaq and MTA: CTIC) today announced that it

has initiated its randomized pivotal trial of pixantrone for the treatment of

relapsed/refractory diffuse large B-cell lymphoma ( " DLBCL " ). The clinical trial

is now open to patient enrollment. The 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. The

PIX-R trial utilizes 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.

" We are pleased to open enrollment for this study and have been in communication

with leading cancer clinical sites that are enthusiastic about participating in

the study largely based on the positive results of our previous study, PIX301,

in relapsed/refractory aggressive non-Hodgkin's lymphoma patients, " said Jack W.

Singer, M.D., Chief Medical Officer of CTI. " There is an unmet medical need in

this patient group, and the lack of any FDA approved drug for these patients

should generate strong interest in the trial from both the patients and

physicians. "

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