In a three-center trial, Immunex Corp.'s GM-CSF has hastenedrecovery after bone marrow transplants following intensivechemotherapy and radiation treatments. As reported in today'sNew England Journal of Medicine, GM-CSF cut hospital staysfor patients by a week on average, with a cost reduction ofabout $20,000.
GM-CSF, or granulocyte macrophage colony stimulating factor,was approved by the Food and Drug Administration in March.This week's report is the full presentation of the study datathat were summarized for the FDA's consideration inDecember, said Immunex spokesman Jason Rubin.
Seattle-based Immunex (NASDAQ:IMNX) is approved to sell itsdrug for use in cancer patients who have had autologous bonemarrow transplants.
Regimens to treat cancers of the lymphoid system may destroya patient's bone marrow, the body's factory for white bloodcells, as well as the cancer. Replacing a patient's marrow,culled before chemotherapy or radiation, can restore apatient's immunity, but a critical three weeks must pass forthe graft to settle and begin to function.
The recombinantly produced colony stimulating factor sends amessage to produce more infection-fighting white blood cells,and also may prod existing white blood cells to work harder.Immunex's product signals both granulocyte and macrophagecells.
Earlier trials of GM-CSF suggested that the drug has few sideeffects and may speed recovery of white blood cells in thebloodstream. The reported study was a double-blind, placebo-controlled trial with 128 patients. The study showedsignificantly fewer infections, less need for antibiotics andsix fewer days of hospitalization with GM-CSF.
While patients given GM-CSF in the present study recoveredwhite blood cell counts one week sooner, the group given thedrug did not on average survive any longer than the placebo-treated patients over the 100 days of the study.
-- Roberta Friedman Special to BioWorld
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