CTI's pixantrone trial data confirmed by second radiology panel

Submitted by Ross Bonander Wed 09/28/2011

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Cell Therapeutics (CTI) today announced that a second independent radiology assessment of the data from the biotech's PIX301 clinical trial (also known as the EXTEND trial) of pixantrone for relapsed or refractory non-Hodgkin's lymphoma "confirmed the statistical robustness" of the data previously submitted to the FDA.

CTI followed through with this second independent radiology assessment—in which a panel of three radiologists examine the data without knowing which arm the patient was in—because it had been part of the recommendations made by the FDA's Office of New Drugs, an aspect of the biotech's appeal of the Complete Response Letter they received from the FDA's Office of Oncology Drug Products last year.

According to James A. Bianco, M.D., CEO of CTI, "The review conducted by a second independent panel of three radiologists confirmed the statistically and clinically significant results the first independent panel reported for the PIX301 study response and progression endpoints."

Curiously, this is the same "statistically robust" data that an independent panel unanimously found insufficient enough to reject in the spring of 2010.

In addition to their ongoing appeal, CTI should be busy recruiting 350 patients for its PIX-R trial.

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