FDA puts Cell Therapeutics blood cancer drug on hold after death

June 24 Mon Jun 24, 2013 6:31am EDT

June 24 (Reuters) - Cell Therapeutics Inc said the U.S. Food and Drug Administration has placed a partial clinical hold on the company's experimental blood cancer drug after the death of a patient.

The patient, being treated with the drug tosedostat in combination with a chemotherapy drug, died of myocarditis, or infection of the heart muscle, the company said in a regulatory filing on Monday. ()

The company said the FDA had asked for more information and a detailed review of all cardiac events or cardiac-related investigations in patients treated with tosedostat.

Under the partial clinical hold, Cell Therapeutics cannot enroll new patients in any of the ongoing tosedostat trials until an agreement is reached with the FDA.

Cell Therapeutics shares closed at $1.22 on the Nasdaq on Friday.

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Comments (1)
Could all this be happening so fast because it was a WA State SEN. Who Died????? If it was you or I, or one of our family members this happen to. Would they pull the trial so fast? Or would they make you and me fight through the WA State Med board to get this kind of action, this fast. We would have to fight the MED board for 2 years, and even then we would have to prove in a court of law that this drug, did indeed cause the the death in question? I dare to ask is the patient referred to in this article Sen. Mike Carrel of WA State???

http://capitolrecord.tvw.org/2013/05/sen-mike-carrell-dies-of-complications-from-pre-cancer-treatment/#.UchlhTS1Eg9

Jun 24, 2013 12:07pm EDT  --  Report as abuse
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