This is a Phase II grant application to further develop long acting G-CSF proteins for the treatment of neutropenia. It is submitted by Bolder Biotechnology, Inc. George N. Cox, PhD, Principal investigator. The investigator notes the recombinant G-CSF has a worldwide sales in excess of $1.2 Billion in 1998. They propose to create modified G-CSF proteins that are equal to or superior than natural G-CSF in stimulating granulocyte formation in-vivo but would require less frequent dosing. Their goal is to have a long acting protein that could be given once a week or every other week. During Phase I they identified sites in the G-CSF that could be modified without reducing the proteins bio-activity in-vitro. During Phase II they plan to manufacture sufficient quantities of the modified G-CSF protein for testing in animal models with neutropenia. It is their contention that these novel G-CSF proteins will reduce the amount of G-CSF required per patient, improve patient compliance and quality of life, and result in considerable cost savings for patients and healthcare providers.
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