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FDA Puts Cell Therapeutics Research on Partial Hold after Patient Death

By Pharmaceutical Processing | June 25, 2013

Shares of Cell Therapeutics Inc. regained some value in premarket trading Tuesday, a day after the stock sank following the drug developer’s announcement that a patient in a clinical study died and regulators had placed a partial hold on the research.

The Seattle company said Monday that a patient who was being treated with a combination of its potential blood cancer treatment tosedostat and some other drugs had died of myocarditis, which is an inflammation of the heart usually caused by an infection.

The company said the drug was being studied in an investigator-sponsored trial and not by Cell Therapeutics. Tosedostat was in mid-stage clinical testing.

The Food and Drug Administration has asked for more information on patients being treated with tosedostat, including more details on the patient who died and information on any cardiac-related investigations into patients treated with tosedostat.

Cell Therapeutics said Tuesday that regulators had placed a hold on only part of the clinical work, and the company has started to comply with the FDA request.

Cell Therapeutics shares sank about 11 percent on Monday to close at $1.09. But the stock rebounded 4 cents to $1.13 Tuesday before markets opened. That put the stock down 13 percent so far this year.

 

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