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Details for Patent: 7,662,933

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Details for Patent: 7,662,933

Title:N-terminally chemically modified protein compositions and methods
Abstract: Provided herein are methods and compositions relating to the attachment of water soluble polymers to proteins. Provided are novel methods for N-terminally modifying proteins or analogs thereof, and resultant compositions, including novel N-terminally chemically modified G-CSF compositions and related methods of preparation. Also provided is chemically modified consensus interferon.
Inventor(s): Kinstler; Olaf B. (Thousand Oaks, CA), Gabriel; Nancy Elise (Thousand Oaks, CA), Farrar; Christine E. (Newbury Park, CA), DePrince; Randolph B. (Raleigh, NC)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Filing Date:Apr 26, 2006
Application Number:11/411,321
Claims:1. A method of treating a hematopoietic disorder, wherein the hematopoietic disorder is a result of a reduced neutrophil count, comprising administering a therapeutically effective dose of a substantially homogeneous preparation of N-terminally monopegylated granulocyte colony stimulating factor (G-CSF) or an analog thereof pegylated via an amine linkage optionally in a pharmaceutically acceptable diluent, carrier, or adjuvant.

2. The method of claim 1, wherein the hematopoietic disorder is a result of an infectious disease.

3. The method of claim 2, wherein the infectious disease is a bacterial, viral, or fungal infectious disease.

4. The method of claim 2, wherein the infectious disease is sepsis.

5. The method of claim 1, wherein the hematopoietic disorder is a result of chemotherapy.

6. The method of claim 1, wherein the hematopoietic disorder is a result of radiation therapy.

7. The method of claim 1, wherein the hematopoietic disorder is severe chronic neutropenia or a leukemia.

8. The method of claim 1, wherein the therapeutically effective dose is in a range of 0.01 .mu.g/kg body weight to 100 .mu.g/kg body weight.

9. The method of claim 1, wherein the polyethylene glycol has a molecular weight of 2 kDa to 100 kDa.

10. The method of claim 9, wherein the polyethylene glycol has a molecular weight of 6 kDa to 25 kDa.

11. The method of claim 10, wherein the polyethylene glycol has a molecular weight of 20 kDa.

12. The method of claim 1, wherein the preparation comprises at least 90% N-terminally-modified G-CSF or analog thereof and at most 10% unpegylated G-CSF or analog thereof.

13. The method of claim 12, wherein the preparation comprises at least 95% N-terminally-modified G-CSF or analog thereof and at most 5% unpegylated G-CSF or analog thereof.

14. The method of claim 1, wherein the G-CSF or analog thereof is not glycosylated.

15. The method of claim 1, wherein the G-CSF or analog thereof has a methionine at the N-terminus.
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