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Claims for Patent: 5,824,642

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Claims for Patent: 5,824,642

Title: Treatment of partial growth hormone insensitivity syndrome
Abstract:Methods for increasing the growth rate of a human patient having partial growth hormone insensitivity syndrome, but not Laron syndrome, are described. One such method comprises administering an effective dose of growth hormone, preferably growth hormone with a native human sequence, with or without an N-terminal methionine, to the patient. The patient is characterized as having a height of less than about -2 standard deviations below normal for age and sex, a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, a serum level of IGF-I that is below normal mean levels, and a serum level of growth hormone that is at least normal. In another such method, the same patient population is treated with an effective amount of IGF-I, given alone or in combination with an amount of growth hormone that is effective in combination with the IGF-I.
Inventor(s): Attie; Kenneth (San Francisco, CA), Carlsson; Lena M. S. (Goteborg, SE), Gesundheit; Neil (Los Altos, CA), Goddard; Audrey (San Francisco, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:08/468,580
Patent Claims: 1. A method for increasing the growth rate of a human patient having partial growth hormone insensitivity syndrome comprising administering an effective amount of growth hormone to said patient, whereby said patient has a height less than about -2 standard deviations below normal for age and sex, has a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, has a serum level of IGF-I that is below normal mean levels, and has a mean or maximum stimulated serum level of growth hormone that is at least normal, wherein the patient does not have Laron syndrome.

2. The method of claim 1 wherein the effective amount of growth hormone is greater than about 0.2 mg/kg/week.

3. The method of claim 1 wherein the effective amount of growth hormone is greater than about 0.25 mg/kg/week.

4. The method of claim 1 wherein the effective amount of growth hormone is greater than or equal to about 0.3 mg/kg/week.

5. The method of claim 1 wherein the growth hormone is administered once per day.

6. The method of claim 5 wherein the growth hormone is administered by subcutaneous injections.

7. The method of claim 1 wherein the growth hormone is formulated at a pH of about 7.4 to 7.8.

8. A method for increasing the growth rate of a human patient having partial growth hormone insensitivity syndrome comprising administering an effective amount of IGF-I to said patient, whereby said patient has a height less than about -2 standard deviations below normal for age and sex, has a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, has a serum level of IGF-I that is below normal mean levels, and has a mean or maximum stimulated serum level of growth hormone that is at least normal, wherein the patient does not have Laron syndrome.

9. The method of claim 8 wherein the amount of IGF-I administered is a dose of about 50 to 240 .mu.g/kg/day.

10. The method of claim 9 wherein the IGF-I is administered once or twice daily.

11. The method of claim 10 wherein the IGF-I is administered by subcutaneous injection.

12. The method of claim 8 wherein the IGF-I is formulated at a pH of about 5-6.

13. A method for increasing the growth rate of a human patient having partial growth hormone insensitivity syndrome comprising administering amounts of IGF-I and growth hormone to said patient which amounts are effective in combination, whereby said patient has a height less than about -2 standard deviations below normal for age and sex, has a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, has a serum level of IGF-I that is below normal mean levels, and has a mean or maximum stimulated serum level of growth hormone that is at least normal, wherein the patient does not have Laron syndrome.

14. The method of claim 13 wherein the IGF-I and growth hormone are together administered by subcutaneous injections.

15. A method for increasing the growth rate of a human patient with non-GH-deficient short stature but not Laron syndrome comprising detecting whether the patient has a height less than about -2 standard deviations below normal for age and sex, has a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, has a serum level of IGF-I that is below normal mean levels, and has a mean or maximum stimulated serum level of growth hormone that is at least normal, and, if so, administering an effective amount of growth hormone that increases the growth rate of the patient to said patient.

16. A method for increasing the growth rate of a human patient with non-GH-deficient short stature but not Laron syndrome comprising detecting whether the patient has a height less than about -2 standard deviations below normal for age and sex, has a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, has a serum level of IGF-I that is below normal mean levels, and has a mean or maximum stimulated serum level of growth hormone that is at least normal, and, if so, administering an effective amount of IGF-I to said patient.
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