MAXYGEN BEGINS STUDY OF PEGYLATED G-CSF
Maxygen has initiated a Phase I trial in the United States to evaluate the safety, tolerability and pharmacokinetic and pharmacodynamic profile of Maxy-G34, a next-generation granulocyte colony-stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia. The trial is a double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Maxy-G34 is a PEGylated proprietary G-CSF variant designed to be administered as a single subcutaneous injection once per chemotherapy cycle.
Maxygen has made changes in the G-CSF gene sequence that code for novel PEGylation sites in the resulting protein. In contrast to the currently marketed PEGylated G-CSF, Maxy-G34 has multiple PEG groups attached at specifically selected sites on the molecule. In several in vivo models, Maxy- G34 has demonstrated improved pharmacokinetics and pharmacodynamics over the currently marketed PEGylated G-CSF.
G-CSF is a natural protein that stimulates the body's bone marrow to produce neutrophils, a specific type of white blood cell that plays an important role in the defense against bacterial infections. Neutropenia is a severe decrease in neutrophil cell counts in the blood and is a common side effect of chemotherapeutic treatments for many forms of cancer.
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