( at was statistically worse than that ob...)Publication on Pixantrone Preclinical Studies Demonstrates Reduced,Cardiotoxicity Compared to Equiactive Doses of Doxorubicin and,Mitoxantrone,Health

at was statistically worse than that observed in the pixantrone-treated mice. In addition, mortality ranged from 40 to 68 percent in mice receiving two cycles of doxorubicin to 68 percent in mice receiving two cycles of mitoxantrone. In mice receiving two cycles of pixantrone, the mortality rate was 0 percent.

Pixantrone in Clinical Studies

There are currently two clinical studies of pixantrone in aggressive NHL patients, including a phase III single agent trial, known as EXTEND and a phase II/III 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 randomized phase II/III study of the CHOP-R versus CPOP-R in previously untreated aggressive NHL patients. The study is evaluating replacing doxorubicin in the standard CHOP-R combination regimen (cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab) with pixantrone as part of the CPOP-R regimen (cyclophosphamide, pixantrone, vincristine, prednisone, and rituximab). The objective of the study is to demonstrate similar objective response rates as the standard doxorubicin-based therapy with significantly less severe cardiac toxicities and other doxorubicin-related toxicities on the CPOP-R arm of the study. A total of 280 patients are expected to be enrolled.

The Company is awaiting feedback from the FDA on the design of a phase III trial of pixantrone for patients with indolent NHL. The trial, PIX303, will examine the complete remission rates and time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of
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