FDA lifts hold on studies testing Cell Therapeutics' cancer drug

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[January 02, 2014]   (Reuters) Cell Therapeutics Inc said the U.S. Food and Drug Administration lifted a hold imposed in June last year on studies testing the company's blood cancer drug.

The company's shares rose about 3 percent to $1.97 in premarket trading on Thursday.

Cell Therapeutics said it received the notification from the regulator on December 26.

The FDA placed the hold after a patient treated with a combination of the drug, tosedostat, and a chemotherapy drug died of a heart muscle infection.

Under the hold, the company could not enroll new patients in any trials of tosedostat.

The regulator asked for more information on all heart-related events in patients treated with the drug.


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Tosedostat is being tested in mid-stage trials in the United States and European Union on elderly patients with two forms of blood cancer  acute myeloid leukemia and myelodysplastic syndrome.

(Reporting by Vrinda Manocha in Bangalore; editing by Kirti Pandey)

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