June 24 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