Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1995-10-12
pubmed:abstractText
PIXY321 is a novel fusion protein of recombinant human granulocyte-macrophage colony-stimulating factor and interleukin-3 that exhibits biologic effects of both its parent cytokines in vitro and in preclinical studies. To evaluate the clinical safety and hematopoietic effects of this hybrid cytokine, PIXY321 was administered by subcutaneous injection twice daily at doses of 25 to 1,000 micrograms/m2/day over 14 days to 24 patients with sarcoma before chemotherapy as part of a phase I trial. The treatment was associated with significant increases in white blood cell, neutrophil, platelet, and reticulocyte counts (all P < .001). The increase in neutrophil count was dose-related and was seen during treatment with the cytokine, whereas the increase in platelet count was gradual and peaked after the cessation of the cytokine treatment and was not clearly dose related. PIXY321 treatment also increased bone marrow (BM) cellularity and the percentage of BM cells in S phase (P < .001). In addition, there was a significant increase in the number of CD34+ cells and committed and multipotential progenitors in the peripheral blood. The ex vivo expansion capacity of peripheral blood and BM progenitor cells was preserved after the in vivo treatment with PIXY321. The treatment was well tolerated, with the most common side-effect being injection site reactions. The results of this study show the biologic and clinical activity of a genetically engineered fusion molecule of two hematopoietic cytokines in humans with normal hematopoietic function.
pubmed:grant
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
0006-4971
pubmed:author
pubmed:issnType
Print
pubmed:day
15
pubmed:volume
86
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
2098-105
pubmed:dateRevised
2007-11-14
pubmed:meshHeading
pubmed-meshheading:7662957-Agranulocytosis, pubmed-meshheading:7662957-Antibody Formation, pubmed-meshheading:7662957-Antineoplastic Agents, pubmed-meshheading:7662957-Blood Cell Count, pubmed-meshheading:7662957-Bone Marrow, pubmed-meshheading:7662957-Bone Marrow Diseases, pubmed-meshheading:7662957-Cells, Cultured, pubmed-meshheading:7662957-Colony-Forming Units Assay, pubmed-meshheading:7662957-Drug Administration Schedule, pubmed-meshheading:7662957-Granulocyte-Macrophage Colony-Stimulating Factor, pubmed-meshheading:7662957-Hematopoiesis, pubmed-meshheading:7662957-Hematopoietic Stem Cells, pubmed-meshheading:7662957-Humans, pubmed-meshheading:7662957-Injections, Subcutaneous, pubmed-meshheading:7662957-Interleukin-3, pubmed-meshheading:7662957-Neutrophils, pubmed-meshheading:7662957-Premedication, pubmed-meshheading:7662957-Recombinant Fusion Proteins, pubmed-meshheading:7662957-Safety, pubmed-meshheading:7662957-Sarcoma, pubmed-meshheading:7662957-Treatment Outcome
pubmed:year
1995
pubmed:articleTitle
In vivo biologic effects of PIXY321, a synthetic hybrid protein of recombinant human granulocyte-macrophage colony-stimulating factor and interleukin-3 in cancer patients with normal hematopoiesis: a phase I study.
pubmed:affiliation
Department of Clinical Immunology and Biological Therapy, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, U.S. Gov't, P.H.S., Research Support, Non-U.S. Gov't, Clinical Trial, Phase I