Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) 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 Pixantrone

Pixantrone 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 mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.

Source:
Cell Therapeutics, Inc.