Significant Difference in Primary Endpoint Could be Acceptable With Fewer
Patients Than Originally Planned
SEATTLE, Sept. 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) (MTAX: CTIC) announced today that following discussions with the U.S. Food and Drug Administration (FDA) regarding its EXTEND (PIX301) trial for patients with aggressive non-Hodgkin's lymphoma (NHL) the Company has decided to conduct a full analysis of the trial instead of an interim analysis as previously planned. The decision was based in part on the Agency's guidance that a primary endpoint analysis of less than the initially-projected 320 eligible patients could be acceptable for New Drug Application (NDA) submission if it is able to demonstrate a statistically significant (p<=0.05) difference between treatment arms. In addition, the FDA agreed that randomized safety data from the RAPID (PIX203) study (CHOP-R vs. CPOP-R) could be used to support the EXTEND results in an NDA submission for pixantrone. Based on this guidance the Company currently anticipates completing enrollment in the EXTEND trial in the fourth quarter of this year with primary endpoint data and final results being reported in the first half of 2008. Pixantrone has received fast track status from the FDA for this indication.
"This was a very important outcome for CTI and the PIX301 trial
timeline. If we achieve the primary endpoint of the study, even with fewer
than 320 patients, we could submit our NDA" said James A. Bianco, M.D.,
President and CEO of CTI. "Going straight to a final analysis will allow us
the potential to submit an NDA for pixantrone and receive approval in 2009.
The inclusion of safety data from the rand
|SOURCE Cell Therapeutics, Inc.|
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