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LONG-ACTING GM-CSF PROTEINS FOR TREATING NEUTROPENIA

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N/A
Agency Tracking Number: 2R44CA084850-02
Amount: $0.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
678 W WILLOW ST
LOUISVILLE, CO 80027
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 DANIEL DOHERTY
 () -
Business Contact
Phone: (303) 735-2296
Email: BOLDERBIO@AOL.COM
Research Institution
N/A
Abstract

DESCRIPTION: (Investigator's abstract) Granulocyte-Macrophage Colony
Stimulating Factor (GM-CSF) is a cytokine that stimulates proliferation and
differentiation of hematopoietic progenitor cells. Recombinant human GM-CSF is
used to stimulate neutrophil production in patients with neutropenia resulting
from myelosuppressive chemotherapy. Recombinant human GMCSF had world-wide
sales of approximately $100 million during 1997, a 20 percent increase from
1996. We propose to create modified GM-CSF proteins that are equal or superior
to natural GM-CSF at stimulating granulocyte/monocyte formation In vivo, but
which require less frequent dosing, on the order of once per week or once every
other week. During Phase I we identified sites in GM-CSF that can be modified
without affecting the protein's in vitro bioactivity. During Phase II, we will
manufacture sufficient quantities of the modified GM-CSF proteins for testing
in animal models of neutropenia. The improved characteristics of the novel
GM-CSF proteins will reduce the amount of GM-CSF required per patient, improve
patient compliance and quality of life and result in considerable cost savings
to patients and healthcare providers. Information gained from these studies
will aid in creating long-acting versions of structurally related cytokines and
growth factors for use in treating cancer, infectious disease and hematopoietic
disorders.
PROPOSED COMMERCIAL APPLICATION:
Recombinant human GM-CSF is used to restore neutrophil production in patients with
neutropenia resulting from chemotherapy or bone marrow transplantation. Recombinant
GM-CSF had world-wide sales in excess of $100 million in 1997. The modified GM-CSF
proteins under development will require much less frequent dosing, providing significant
cost savings to patients and healthcare providers. Additional potential benefits include
improved drug efficacy and improved patient quality of life.

* Information listed above is at the time of submission. *

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