US5126324A
Expired / Lapsed
US
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Method of enhancing growth in patients using combination therapy
Assignee: Genentech Inc
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Filing: 1990-06-07
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Granted: 1992-06-30
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Expires: 2010-06-07
Abstract
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.
Inventors
- 👤 Ross G. Clark
- 👤 Michael J. Cronin
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 14:25
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/27; A61K38/30; A61K47/00; A61K47/06; A61K47/08; A61K47/10; A61P; A61P43/00; A61P5/00; A61K47/12; A61K47/26
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
56 words
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.
Claim 2
Independent Claim
56 words
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.
Claim 3
Dependent Claim
11 words
The method of claim 1 wherein the mammal is an animal.
Claim 4
Dependent Claim
27 words
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.
Claim 5
Dependent Claim
11 words
The method of claim 1 wherein the mammal is a human.
Claim 6
Dependent Claim
11 words
The method of claim 4 wherein the human is a non-adult.
Claim 7
Dependent Claim
21 words
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.
Claim 8
Dependent Claim
12 words
The method of claim 6 wherein the IGF-I has no N-terminal methionine.
Claim 9
Dependent Claim
24 words
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.
Claim 10
Dependent Claim
28 words
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.
Claim 11
Dependent Claim
10 words
The method of claim 9 wherein the IGF-I is des(1-3)-IGF-I.
Claim 12
Dependent Claim
21 words
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.
Claim 13
Dependent Claim
20 words
The method of claim 6 wherein the IGF-I is in a sterile, isotonic solution containing a citrate buffer, pH 6.
Claim 14
Dependent Claim
11 words
The method of claim 6 wherein the GH is recombinant GH.
Claim 15
Dependent Claim
22 words
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.
Claim 16
Dependent Claim
13 words
The method of claim 1 wherein the IGF-I is administered by continuous infusion.
Claim 17
Dependent Claim
21 words
The method of claim 15 wherein the administration of GH or IGF-I or both is by the subcutaneous or intravenous route.
Claim 18
Dependent Claim
18 words
The method of claim 1 wherein the administration of both GH and IGF-I is by the subcutaneous route.
Claim 19
Dependent Claim
12 words
The method of claim 15 wherein the GH is injected once daily.
Claim 20
Dependent Claim
20 words
The method of claim 1 wherein the effective amount of each of GH and IGF-I is at least 0.1 mg/kg/day.
Claim 21
Dependent Claim
20 words
The method of claim 4 wherein the effective amount of each of GH and IGF-I is at least 1 mg/kg/day.
Claim 22
Dependent Claim
13 words
The method of claim 1 wherein the IGF-I and GH are administered separately.
Claim 23
Dependent Claim
16 words
The method of claim 1 wherein the IGF-I and GH are administered as a single formulation.
Claim 24
Dependent Claim
13 words
The method of claim 4 wherein the human to be treated has diabetes.
Claim 25
Dependent Claim
19 words
The method of claim 4 wherein the human to be treated experiences hyperinsulinemia or hyperglycemia with GH treatment alone.
Claim 26
Dependent Claim
21 words
The method of claim 4 wherein the human to be treated exhibits a reduced anabolic effect when treated with GH alone.
Claim 27
Dependent Claim
33 words
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.
Claim 28
Dependent Claim
26 words
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.
Claim 29
Dependent Claim
25 words
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.
Claim 30
Dependent Claim
25 words
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.
References Cited (Backward Citations)
WO1989009792A1
Cited
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1995-06-30 | 1995-12-30 | 1996-06-30 | $2000.00 | Window Closed / Lapsed |
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