Cell Therapeutics Advances non-Hodgkin’’s Lymphoma in E.U. (CTIC)

September 15, 2009 · Filed Under Cancer 

Cell Therapeutics, Inc. (NASDAQ: CTIC) is running higher on the report that it has advanced its Pixantrone filing process in Europe.  It has submitted a Pediatric Investigation Plan to the European Medicines Agency as part of the required filing process.

This is required to seek approval of pixantrone as a treatment for relapsed or refractory aggressive non-Hodgkin’’s Lymphoma in Europe.

The PIP outlines how the company proposes to study the drug in children in order to benefit child health.  The company noted that anthracyclines are a mainstay in the treatment of childhood leukemias, lymphomas and solid tumors but long-term cardiotoxicity represents a significant issue.  Cell Therapeutics plans to evaluate safety and efficacy of pixantrone in pediatric cancer patients.

CTI recently received a prescription drug user fee act action date of April 23, 2010 in the U.S. regarding CTI’s New Drug Application for pixantrone as potential treatment for relapsed or refractory, aggressive non-Hodgkin’s lymphoma.

Right before the open we have seen over 1 million shares and shares are up close to 6% at $1.45.  The 52-week high is $2.23

JON C. OGG
September 15, 2009

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