Immunex Inc.'s granulocyte macrophage colony stimulatingfactor (GM-CSF) appears to be safe in children and lessen theside effects of chemotherapy (CT).
"This is the first published study of GM-CSF in childrenundergoing CT," said Immunex spokesman Jason Rubin. "Thequestion we hope to answer in the months ahead is what dosesof GM-CSF will be most effective in permitting the use of higherdoses of chemotherapeutic agents," he said.
Chemotherapy often reduces the white blood cell count, leavingpatients susceptible to infection. GM-CSF boosts the growth ofwhite blood cells.
Researchers at St. Jude Children's Research Hospital inMemphis, Tenn., reported in Thursday's Journal of ClinicalOncology that all 25 children administered GM-CSF toleratedthe drug well, even at doses that are three to four times thosetolerated by adults.
The study found that chemotherapy patients given high dosesof GM-CSF required 50 percent fewer days of antibiotic therapythan patients receiving low doses.
A Phase II controlled, randomized study will begin at St. Judelater this year, said hospital spokeswoman Deborah McCreery.The scientists are also evaluating whether they can inject GM-CSF under the skin rather than administer it intravenously.
Seattle-based Immunex received Food and Drug Administrationapproval in March to sell its Leukine GM-CSF to cancer patientswho have had autologous bone marrow transplants. Thecompany is testing GM-CSF on adults undergoing CT.
Amgen Inc. received FDA approval in February for Neupogen,or G-CSF (granulocyte CSF), to decrease the incidence ofinfection associated with cancer drugs that reduce white bloodcell count. G-CSF can be given to children even though efficacyhas not yet been demonstrated, said Amgen spokeswomanKimberley Dorsey. Amgen has shown that G-CSF is safe inchildren, and the company is the process of conducting efficacystudies, she said.
Immunex stock (NASDAQ:IMNX) closed Thursday at $45, up$1.25.
-- Carol Talkington Verser, Ph.D. Special to BioWorld
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