SEATTLE, Nov. 1, 2010 /PRNewswire/ — Cell Therapeutics, Inc.
(“CTI”) (Nasdaq and MTA: CTIC) announced today that it has
submitted a Marketing Authorization Application (“MAA”) to the
European Medicines Agency (“EMA”) for Pixuvri® (pixantrone
dimaleate) as monotherapy for the treatment of adult patients with
multiply relapsed or refractory aggressive non-Hodgkin’s lymphoma
(“NHL”). The application submission follows a positive opinion from
the EMA’s Pediatric Committee (the “PDCO”), where PDCO agreed to
CTI’s Pediatric Investigation Plan (“PIP”) for Pixuvri.
“This is an important milestone for CTI, and underscores our
commitment to making pixantrone available to patients who currently
have no approved or effective therapies for this life threatening
disease,” said James A. Bianco, M.D., CEO of CTI. “We appreciate
the efforts of all the people who made the MAA submission possible,
especially the investigators and patients who participated in our
clinical trial.”
“PIX301 was not only the first and only randomized trial in this
patient population, it was also the largest study ever conducted
for patients with multiply relapsed and refractory aggressive NHL.
The positive results of this trial are among the most effective
ever reported in this group of patients,” noted Ruth Pettengell,
M.D., of St. George’s Hospital, University of London, the principal
investigator on the study. “The robustness of the drug’s effect in
prolonging progression free survival irrespective of risk factors
lends to the strength and credibility of the clinical benefit
provided to patients in the trial. Currently there are no approved
drugs available to patients today as such pixantrone will be a
valuable new addition to offer these patients a new hope for
controlling their disease.”
Pixantrone was granted orphan drug status by the EMA for the
treatment of diffuse large B-cell lymphoma (DLBCL). CTI expects
that the EMA will make a determination regarding the ac
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