Maxygen starts phase 1 trial for Maxy-G34

By Elaine Rigoli

Tampa, Fla., Sept. 5 - Maxygen, Inc. said it started a phase 1 clinical trial in the United States to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of Maxy-G34, a granulocyte colony stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia.

The ongoing clinical 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.

The Redwood City, Calif.-based pharmaceutical company said it 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, the company said Maxy-G34 demonstrated improved pharmacokinetics and pharmacodynamics compared to the currently marketed PEGylated G-CSF.

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