SEATTLE, March 3, 2011 /PRNewswire/ — Cell Therapeutics, Inc.
(“CTI”) (Nasdaq and MTA: CTIC) today announced that it has met with
officials of the FDA’s Office of New Drugs (“OND”) in Maryland and
presented its arguments supporting the Company’s belief that the
data contained in its New Drug Application (“NDA”) 22-481 support
the conclusion that pixantrone is effective for its planned
use.
“We appreciate OND’s consideration of our appeal. While we
understand disputes of this type are a challenging process, we felt
compelled to seek this review based on the PIX301 results and lack
of approved therapies for these patients with an unmet medical
need. CTI is committed to the advancement of pixantrone,”
said James A. Bianco, M.D., CEO of CTI.
At the meeting, the OND requested additional analyses from the
PIX301 Phase III clinical study. CTI intends to submit the
requested information and expects that this will reset the time
period for OND to provide its decision on the appeal. CTI
anticipates a decision in the second quarter of 2011.
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.
These structural differences resulted in significantly
enhanced anti-lymphoma activity compared to doxorubicin in
preclinical models. In addition, the structural motifs on
anthracycline-like agents that are responsible for the generation
of oxygen free radicals and the formation of toxic drug-metal
complexes have also been modified in pixantrone to prevent the
binding of iron and perpetuation of superoxide production–both of
which are the putative
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