FDA lifts a partial hold on Cell Therapeutics' leukemia drug

Cell Therapeutics ($CTIC) got some good news from the FDA to start 2014. The agency has lifted a partial hold on tosedostat (IND 075503), giving the Seattle-based biotech a green light for all clinical studies of the cancer drug.

The FDA had clamped a partial hold on the mid-stage drug last summer, after a patient taking the drug in a study died of myocarditis, an inflammation of heart muscle. Cell Therapeutics shares barely budged today, though, perhaps reflecting a wary investment community which had tired long ago of the biotech's erratic course.

Cell Therapeutics bought tosedostat for a mere $10 million. The experimental therapy inhibits aminopeptidases, and the biotech is developing it in Phase II for acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).

CTIC is perhaps best known for losing a unanimous vote by outside FDA experts after agency cancer czar Richard Pazdur laid into the program for Pixuvri (pixantrone), which failed to demonstrate a statistically significant improvement over the control arm.

"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, a researcher at the prestigious Fred Hutchinson Cancer Research Center and the principal investigator in the tosedostat first-line AML/MDS trial, in a statement.

- here's the release