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Details for Patent: 5,126,324

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Details for Patent: 5,126,324

Title: Method of enhancing growth in patients using combination therapy
Abstract:A method is disclosed for enhancing growth of a mammal by administration of a combination of effective amounts of IGF-I and GH so as to enhance the growth of the mammal over the enhancement in growth achieved using either IGF-I or GH alone in an amount equal to that used for either IGF-I or GH, respectively, in the combination. Preferably, the mammal is a child, the IGF-I is native-sequence, mature human IGF-I or human brain IGF-I, and the GH is native-sequence, mature human GH with or without a terminal methionine. In another preferred embodiment, the mammal is a non-human animal of economic importance such as a cow or pig.
Inventor(s): Clark; Ross G. (Pacifica, CA), Cronin; Michael J. (San Mateo, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Filing Date:Jun 07, 1990
Application Number:07/535,005
Claims:1. A method for enhancing growth of a mammal comprising administering systemically and concurrently to the mammal effective amounts of IGF-I and GH, wherein the GH is administered by injections, so as to enhance said growth of the mammal over the enhancement in growth achieved using an equivalent dose of IGF-I or GH alone, without incurring hypoglycemia.

2. The method of claim 1 wherein the mammal is an animal.

3. The method of claim 2 wherein the GH and IGF-I are bovine, ovine, or porcine GH or IGF-I, and the animal is bovine, ovine, or porcine, respectively.

4. The method of claim 1 wherein the mammal is a human.

5. The method of claim 4 wherein the human is a non-adult.

6. The method of claim 4 wherein the IGF-I is human native-sequence, mature IGF-I and the GH is human native-sequence, mature GH.

7. The method of claim 6 wherein the IGF-I has no N-terminal methionine.

8. The method of claim 6 wherein the IGF-I has a specific activity of greater than about 14,000 units/mg by radioreceptor assay using placenta membranes.

9. The method of claim 6 wherein the IGF-I is a human native-sequence IGF-I analog having the glutamic acid at position 3 replaced by another amino acid or deleted.

10. The method of claim 9 wherein the IGF-I is des(1-3)-IGF-I.

11. The method of claim 10 wherein the des(1-3)-IGF-I is in a sterile, isotonic solution containing acetic acid, pH 3.2 to 4.5.

12. The method of claim 6 wherein the IGF-I is in a sterile, isotonic solution containing a citrate buffer, pH 6.

13. The method of claim 6 wherein the GH is recombinant GH.

14. The method of claim 13 wherein the GH is in a sterile, isotonic solution containing mannitol and a phosphate buffer, pH 7.4-7.8.

15. The method of claim 1 wherein the IGF-I is administered by continuous infusion.

16. The method of claim 15 wherein the administration of GH or IGF-I or both is by the subcutaneous or intravenous route.

17. The method of claim 1 wherein the administration of both GH and IGF-I is by the subcutaneous route.

18. The method of claim 15 wherein the GH is injected once daily.

19. The method of claim 1 wherein the effective amount of each of GH and IGF-I is at least 0.1 mg/kg/day.

20. The method of claim 4 wherein the effective amount of each of GH and IGF-I is at least 1 mg/kg/day.

21. The method of claim 1 wherein the IGF-I and GH are administered separately.

22. The method of claim 1 wherein the IGF-I and GH are administered as a single formulation.

23. The method of claim 4 wherein the human to be treated has diabetes.

24. The method of claim 4 wherein the human to be treated experiences hyperinsulinemia or hyperglycemia with GH treatment alone.

25. The method of claim 4 wherein the human to be treated exhibits a reduced anabolic effect when treated with GH alone.

26. The method of claim 25 wherein the human to be treated has reached a maximum growth level and then a decrease in annualized growth rate after having previously been treated with GH alone.

27. The method of claim 25 wherein the human to be treated is at an age that is 2-3 years before his or her growth plate closes.

28. The method of claim 4 wherein the effective amount of GH is less than the dose that gives a maximal growth response using GH alone.

29. The method of claim 4 wherein the effective amount of GH is greater than the dose that gives a maximal growth response using GH alone.
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