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FDA Lifts Clinical Hold on Cell Therapeutics Drug

Phase II Tosedostat trials in blood cancer resume

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By: Kristin Brooks

Managing Editor, Contract Pharma

Cell Therapeutics, Inc. has received notification from FDA lifting the partial clinical hold on tosedostat (IND 075503), allowing all studies to continue. Tosedostat, a selective inhibitor of aminopeptidases, which are necessary for growth and tumor cell survival, is under development for the treatment of blood-related cancers. Tosedostat is currently being studied in Phase II trials in elderly patients with newly diagnosed and relapsed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).
 
“We are pleased that the FDA has responded favorably to the tosedostat clinical trial data provided and removed the partial clinical hold to allow further development of tosedostat in ongoing and future studies,” said John Pagel, M.D., Ph.D., principal investigator in the tosedostat first-line AML/MDS trial.

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