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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
S Vadhan-Raj, HE Broxmeyer, M Andreeff, JC Bandres, ES Buescher, RS Benjamin, NE Papadopoulos, A Burgess, S Patel and C Plager
Department of Clinical Immunology and Biological Therapy, University of
Texas M.D. Anderson Cancer Center, Houston 77030, USA.
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.
Volume 86,
Issue 6,
pp. 2098-2105,
09/15/1995
Copyright © 1995 by The American Society of Hematology
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