SEATTLE, Dec. 3, 2010 /PRNewswire/ — Cell Therapeutics, Inc.
(“CTI”) (Nasdaq and MTA: CTIC) today announced that it has
submitted a formal appeal to the Office of New Drugs in the U.S.
Food and Drug Administration’s Center for Drug Evaluation and
Research regarding the agency’s decision from earlier this year on
the pixantrone New Drug Application (“NDA”) to treat
relapsed/refractory aggressive non-Hodgkin’s lymphoma (“NHL”). CTI
had requested accelerated approval of its pixantrone NDA for a
patient group for which there are no drugs currently approved in
this clinical setting. The Office of Oncology Drug Products issued
a Complete Response Letter to CTI related to this NDA stating, in
part, that CTI’s prior clinical trial, PIX301, did not demonstrate
efficacy, and that CTI should conduct an additional clinical trial
prior to approval. Although CTI is preparing to initiate its PIX306
trial, which would serve as either a post-approval confirmatory
trial or a second registration trial for approval, CTI has filed an
appeal under the FDA’s formal dispute resolution process asking the
Office of New Drugs to conclude that PIX301 demonstrated
efficacy.
“We believe the FDA diverged from accepted statistical
principles and practices when the FDA applied a more stringent
statistical significance level in concluding that the PIX301
primary analysis required an adjustment for type 1 error as if an
interim analysis had been conducted. This was not the case in the
PIX301 trial where only a single final analysis was undertaken,”
said Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd.,
Honorary Visiting Professor, School of Pharmacy, Cardiff
University. “We believe the results of the PIX301 clinical trial
should be analyzed with the appropriate threshold that is standard
for trials of this type in which only one efficacy analysis was
conducted.”
FDA regulations provide a formal dispute resolution process to
obtain review of any FDA decision, including a
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