FDA lifts hold on studies testing Cell Therapeutics' cancer drug tosedostat

By Reuters Staff

(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 tosedostat.

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 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.

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

The company notes on its website that tosedostat is a "novel, orally administered aminopeptidase inhibitor that deprives tumor cells of the amino acid building blocks they need to make proteins necessary for tumor cell survival. Tosedostat has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in Phase 1-2 clinical trials."

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