( ercent in the rituximabarm. With...)Pixantrone Granted Fast Track Designation by FDA for Relapsed,Indolent NHL Patients,Health

"With fast track designation already granted for pixantrone in aggressive NHL, this designation for indolent NHL is an important step in the development of this product and may help us bring this potentially life-saving drug to patients more quickly," stated James A. Bianco, M.D., President and CEO of CTI.

CTI is awaiting feedback from the FDA on the design of its PIX303 trial, which will examine the time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have failed up to five prior treatments for relapsed or refractory NHL. The trial, submitted under the FDA's Special Protocol Assessment procedure, is expected to enroll 300 patients beginning in the second quarter with interim data by mid-2008

Pixantrone Clinical Trials

Pixantrone has been studied extensively in aggressive NHL patients, including two ongoing studies, a phase III single agent trial, known as EXTEND and a phase II combination study, known as RAPID. The EXTEND trial explores the role of single agent treatment as a salvage regimen in patients with relapsed aggressive NHL who have failed at least two prior treatment regimens. Patients are randomized to receive either pixantrone or another single-agent drug of physician's choice currently used for the treatment of this patient population. An interim look is planned for the summer of 2007.

The RAPID trial is a first-line phase II study in aggressive NHL patients that will evaluate pixantrone as part of the CPOP-R combination regimen (cyclophosphpamide, pixantrone, vincristine, prednisone and rituximab) compared to the standard treatment regimen, CHOP-R (cyclophosphpamide, doxorubicin, vincristine, prednisone and rituximab). This study will explore the potential cardiac safety benefits of pixantrone
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