Monday, June 24, 2013
FDA puts Cell Therapeutics blood cancer drug on hold after death
(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.
(Reporting by Pallavi Ail in Bangalore; Editing by Don Sebastian)
This entry passed through the Full-Text RSS service — if this is your content and you're reading it on someone else's site, please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: 'You Say What You Like, Because They Like What You Say' - http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/731-you-say-what-you-like-because-they-like-what-you-say.html
