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European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP)Tentatively Scheduled to Render an Opinion on PixuvriTM Marketing Authorization Application on January 19, 2012
Date:12/4/2011

al in patients with prior rituximab treatment as well as its other proposed responses to the list of outstanding issues. Based on feedback at the meeting,  CTI believes its day 181 response submission can resolve this last outstanding major clinical objection as well as the minor concerns.

The basis for the MAA submission was CTI's pivotal randomized trial, PIX301, which compared Pixuvri to other available single agent therapies in the treatment of patients with relapsed or refractory aggressive NHL who failed two or more prior lines of therapy—a patient population for which there are currently no approved effective therapies.

The MAA review process involves a series of interactions between the applicant and the CHMP review team. After 120 days following the acceptance of the MAA, the applicant receives a list of outstanding issues, including major objections to approval. Any remaining issues are provided to the applicant at day 180 in the review cycle. If major objections remain after the applicant provides responses to the day 180 list of outstanding issues, the CHMP may request an oral explanation to address those remaining major objections. If major objections are adequately addressed  in the applicant's day 180 response submission, then the CHMP can  determine the approvability of the MAA without requiring an oral explanation. CTI is required to submit its day 181 responses to the day 180 list of outstanding issues by December 19, 2011 unless CTI deems it requires more time and requests an extension. At present CTI believes it will have all the requisite information and analyses to address all of the outstanding issues.

About Pixuvri (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 -- r
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SOURCE Cell Therapeutics, Inc.
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