SEATTLE, Nov. 18, 2010 /PRNewswire/ — Cell Therapeutics, Inc.
(“CTI”) (Nasdaq and MTA: CTIC) announced today that CTI’s Marketing
Authorization Application (“MAA”) seeking approval for
Pixuvri™ (pixantrone dimaleate) for the treatment of adult
patients with multiply relapsed or refractory aggressive
non-Hodgkin’s lymphoma (“NHL”) was validated and accepted for
review by the European Medicines Agency (“EMA”). Validation
indicates that the application is complete and that the EMA’s
review process has begun.
“We look forward to working with our rapporteurs and the EMA
during their review process in an effort to bring pixantrone to
patients for whom there are currently no available drugs in this
setting,” said James A. Bianco, M.D., CEO of CTI.
The EMA’s review of the MAA will follow the centralized
marketing authorization procedure and, if the MAA is approved,
Pixuvri expects to receive marketing authorization in the E.U.
member states.
The Company also plans, in 2011, to submit a marketing
application in selected other countries beginning with
Switzerland.
Pixantrone was initially granted orphan drug status by the EMA
for the treatment of diffuse large B-cell lymphoma (DLBCL), but
based on the expansion of the current MAA to the broader aggressive
NHL population, CTI has agreed to withdraw the orphan designation
from the E.U. register.
About PixantronePixantrone is a novel aza-anthracenedione
that has distinct structural and physio-chemical properties that
make its anti-tumor activity unique in this class of agents.
Similar to anthracyclines, pixantrone inhibits Topo-isomerase II
but unlike anthracyclines–rather than intercalation with
DNA–pixantrone alkylates DNA–forming stable DNA adducts, with
particular specificity for CpG rich, hyper-methylated sites. We
believe that these structural differences resulted in significantly
enhanced anti-lymphoma activity compared to doxorubicin in
preclinical models. In addition
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