CA2583823A1 - Platelet-derived growth factor compositions and methods of use thereof - Google Patents

Platelet-derived growth factor compositions and methods of use thereof Download PDF

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Publication number
CA2583823A1
CA2583823A1 CA002583823A CA2583823A CA2583823A1 CA 2583823 A1 CA2583823 A1 CA 2583823A1 CA 002583823 A CA002583823 A CA 002583823A CA 2583823 A CA2583823 A CA 2583823A CA 2583823 A1 CA2583823 A1 CA 2583823A1
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Prior art keywords
pdgf
poly
bone
implant material
beta
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CA002583823A
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French (fr)
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CA2583823C (en
Inventor
Samuel E. Lynch
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Biomimetic Therapeutics LLC
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Biomimetic Therapeutics, Inc.
Samuel E. Lynch
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Priority to CA 2726144 priority Critical patent/CA2726144C/en
Publication of CA2583823A1 publication Critical patent/CA2583823A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/28—Bones
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    • A—HUMAN NECESSITIES
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • A61K38/1858—Platelet-derived growth factor [PDGF]
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/425—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of phosphorus containing material, e.g. apatite
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475—Growth factors; Growth regulators
    • C07K14/49—Platelet-derived growth factor [PDGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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Abstract

A method for promoting growth of bone, periodontium, ligament, or cartilage in a mammal by applying to the bone, periodontium, ligament, or cartilage a composition comprising platelet-derived growth factor at a concentration in the range of about 0.1 mg/mL to about 1.0 mg/mL in a pharmaceutically acceptable liquid carrier and a pharmaceutically-acceptable solid carrier.

Claims (78)

1. A method for promoting growth of bone, periodontium, ligament, or cartilage of a mammal comprising administering to said mammal an implant material comprising platelet-derived growth factor (PDGF) at a concentration in the range of about 0.1 mg/mL to about 1.0 mg/mL in a pharmaceutically acceptable liquid carrier and a pharmaceutically acceptable solid carrier, wherein said implant material promotes the growth of said bone, periodontium, ligament, or cartilage.
2. The method of claim 1, wherein said PDGF has a concentration of about 0.3 mg/mL.
3. The method of claim 2, wherein said PDGF has a concentration of 0.3 mg/mL.
4. The method of claim 1, wherein said pharmaceutically acceptable solid carrier comprises one or more of the following: a biocompatible binder, a bone substituting agent, or a gel.
5. The method of claim 4, wherein said biocompatible binder is a natural or synthetic polymer.
6. The method of claim 5, wherein said natural or synthetic polymer is selected from polysaccharides, nucleic acids, carbohydrates, proteins, polypeptides, collagen, poly(.alpha.-hydroxy acids), poly(lactones), poly(amino acids), poly(anhydrides), poly(orthoesters), poly(anhydride-co-imides), poly(orthocarbonates), poly(.alpha.-hydroxy alkanoates), poly(dioxanones), poly(phosphoesters), polylactic acid, poly(L-lactide) (PLLA), poly(D,L-lactide) (PDLLA), polyglycolic acid, polyglycolide (PGA), poly(lactide-co-glycolide (PLGA), poly(L-lactide-co-D, L-lactide), poly(D,L-lactide-co-trimethylene carbonate), polyhydroxybutyrate (PHB), poly(.epsilon.-caprolactone), poly(.delta.-valerolactone), poly(.gamma.-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, polymethylmethacrylate, carbon fibers, poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers, poly(ethylene terephthalate)polyamide, and copolymers and mixtures thereof.
7. The method of claim 5, wherein said natural or synthetic polymer is selected from collagen, polyglycolic acid, polylactic acid, and polymethylmethacrylate.
8. The method of claim 4, wherein said biocompatible binder is selected from alginic acid, arabic gum, guar gum, xantham gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,O-carboxymethyl chitosan, a dextran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, a cellulose, a glucosamine, a proteoglycan, a starch, lactic acid, a pluronic, sodium glycerophosphate, collagen, glycogen, a keratin, silk, and derivatives and mixtures thereof.
9. The method of claim 4, wherein said biocompatible binder is sodium hyaluronate or derivatives thereof.
10. The method of claim 9, wherein said biocompatible binder is hyaluronic acid.
11. The method of claim 4, wherein said biocompatible binder is selected from methylcellulose, carboxymethylcellulose, hydroxypropyl methylcellulose, or hydroxyethyl cellulose.
12. The method of claim 10, wherein said biocompatible binder is carboxymethylcellulose.
13. The method of claim 8, wherein said dextran is .alpha.-cyclodextrin, ,.beta.-cyclodextrin, .gamma.-cyclodextrin, or sodium dextran sulfate.
14. The method of claim 8, wherein said starch is hydroxyethyl starch or starch soluble.
15. The method of claim 4, wherein said bone substituting agent is selected from a calcium phosphate, calcium sulfate, or demineralized bone.
16. The method of claim 15, wherein said calcium phosphate is selected from tricalcium phosphate, hydroxyapatite, poorly crystalline hydroxyapatite, amorphous calcium phosphate, calcium metaphosphate, dicalcium phosphate dihydrate, heptacalcium phosphate, calcium pyrophosphate dihydrate, calcium pyrophosphate, and octacalcium phosphate.
17. The method of claim 15, wherein said calcium phosphate is provided as a paste or putty that forms a hardened calcium phosphate upon in vivo administration.
18. The method of claim 15, wherein said calcium phosphate is provided as a hardened calcium phosphate.
19. The method of claim 15, wherein said calcium phosphate is bioresorable.
20. The method of claim 16, wherein said tricalcium phosphate is .beta.-tricalcium phosphate (.beta.-TCP).
21. The method of claim 20, wherein said .beta.-TCP comprises a matrix of micron- or submicron-sized particles.
22. The method of claim 21, wherein said .beta.-TCP particles have a size of less than about 5000 µm.
23. The method of claim 21, wherein said .beta.-TCP particles have a size in the range of about 100 to about 5000 µm.
24. The method of claim 23, wherein said .beta.-TCP particles have a size in the range of about 100 to about 3000 µm.
25. The method of claim 24, wherein said .beta.-TCP particles have a size in the range of about 250 to about 2000 µm.
26. The method of claim 21, wherein said .beta.-TCP particles are porous.
27. The method of claim 26, wherein said .beta.-TCP particles are greater than 40% porous.
28. The method of claim 27, wherein said .beta.-TCP particles are greater than 65% porous.
29. The method of claim 28, wherein said .beta.-TCP particles are greater than 90% porous.
30. The method of claim 20, wherein said .beta.-TCP is provided in a shape suitable for implantation.
31. The method of claim 30, wherein said shape is selected from a sphere, a cylinder, and a block.
32. The method of claim 15, wherein said demineralized bone is cortical or cancellous bone.
33. The method of claim 1, wherein said pharmaceutically acceptable liquid carrier is selected from water, a physiologically acceptable buffer, or a cell culture medium.
34. The method of claim 33, wherein said physiologically acceptable buffer is sodium acetate buffer.
35. The method of claim 1, wherein said composition further comprises a biologically active agent.
36. The method of claim 35, wherein said biologically active agent is selected from an antibody, an antibiotic, a polynucleotide, a polypeptide, a protein, an anti-cancer agent, a growth factor, an anti-inflammatory agent, and a vaccine.
37. The method of claim 36, wherein said protein is an osteogenic protein.
38. The method of claim 37, wherein said osteogenic protein is selected from insulin-like growth factor I(IGF-I), insulin-like growth factor II(IGF-II), transforming growth factor-.beta.1 (TGF-.beta.1), transforming growth factor-.beta.2 (TGF-.beta.2), transforming growth factor-.alpha.(TGF-.alpha.), a bone morphogenetic protein (BMP), or osteogenin.
39. The method of claim 1, wherein said implant material further comprises autologous bone marrow or autologous platelet extracts.
40. The method of claim 1, wherein said PDGF is partially or substantially purified.
41. The method of claim 1, wherein said PDGF is obtained from a natural source or a recombinant source.
42. The method of claim 41, wherein said natural source comprises blood, platelets, serum, platelet concentrate, platelet-rich plasma (PRP), or bone marrow.
43. The method of claim 41, wherein said natural source is platelet-rich plasma (PRP).
44. The method of claim 1, wherein said implant material delivers said PDGF
to said bone, periodontium, ligament, or cartilage for at least 1 day following administration.
45. The method of claim 1, wherein said implant material delivers said PDGF
to said bone, periodontium, ligament, or cartilage for less than about 28 days following administration.
46. The method of claim 1, wherein said implant material delivers said PDGF
to said bone, periodontium, ligament, or cartilage for less than about 21 days following administration.
47. The method of claim 1, wherein said implant material delivers said PDGF

to said bone, periodontium, ligament, or cartilage for less than about 14 days following administration.
48. The method of claim 1, wherein said implant material delivers said PDGF
to said bone, periodontium, ligament, or cartilage from about 1 day to about 14 days following administration.
49. The method of claim 1, wherein said bone, periodontium, ligament, or cartilage is damaged.
50. The method of claim 1 further coinprising the step of allowing said bone, periodontium, ligament, or cartilage to grow.
51. The method of claim 50 further comprising the steps of exposing said bone, periodontium, ligament, or cartilage by producing a surgical flap of skin prior to administering said implant material, and replacing said flap after administering said implant material.
52. The method of claim 51 further comprising, following the step of producing a surgical flap of skin to expose said bone, periodontium, or ligament, but prior to step (a), the step of planing said bone or periodontium to remove organic matter from said bone or periodontium.
53. The method of claim 1, wherein said PDGF is released from the implant material upon administration at an average rate of less than or equal to 300 µg/day.
54. The method of claim 1, wherein said PDGF is released from the implant material upon administration at an average rate of less than 100 µg/day.
55. The method of claim 1, wherein said PDGF is released from the implant material upon administration at an average rate of less than 50 µg/day.
56. The method of claim 1, wherein said PDGF is released from the implant material upon administration at an average rate of less than 10 µg/day.
57. The method of claim 1, wherein said PDGF is released from the implant material upon administration at an average rate of less than 1 µg/day.
58. The method of claim 1, wherein said pharmaceutically acceptable liquid carrier is sterile.
59. The method of claim 1, wherein said PDGF is PDGF AA, PDGF BB, PDGF CC, or PDGF DD, or combinations or derivatives thereof.
60. The method of claim 59, wherein said PDGF is PDGF-BB.
61. The method of claim 59, wherein said PDGF is PDGF-AB.
62. A method for promoting growth of bone, periodontium, ligament, or cartilage of a mammal comprising (a) administering to said mammal an implant
63 material comprising platelet-derived growth factor (PDGF) at a concentration in the range of less than or equal to 0.3 mg/mL in a pharmaceutically acceptable liquid carrier and a pharmaceutically acceptable solid carrier, wherein said implant material promotes the growth of said bone, periodontium, ligament, or cartilage.

63. A vial comprising platelet-derived growth factor (PDGF) at a concentration in the range of about 0.1 mg/mL to about 1.0 mg/mL in a pharmaceutically acceptable liquid.
64. The vial of claim 63, wherein said liquid is sterile sodium acetate buffer.
65. The vial of claim 63 comprising PDGF at a concentration of about 0.3 mg/mL.
66. The vial of claim 63, wherein said PDGF is PDGF-BB.
67. The vial of claim 64, wherein said PDGF is stable in said buffer for at least 36 months when stored at a temperature in the range of 2°C to 80°C.
68. The vial of claim 64, wherein said PDGF is stable for at least 24 months when stored at a temperature in the range of 2°C to 80°C.
69. The vial of claim 64, wherein said PDGF is stable for at least 18 months when stored at a temperature in the range of 2°C to 80°C.
70. The vial of claim 64, wherein said PDGF is stable for at least 12 months when stored at a temperature in the range of 2°C to 80°C
71. An implant material comprising a porous calcium phosphate having adsorbed therein a liquid comprising platelet-derived growth factor (PDGF) at a concentration in the range of about 0.1 mg/mL to about 1.0 mg/mL.
72. The implant material of claim 71, wherein the concentration of PDGF is about 0.3 mg/mL.
73. The implant material of claim 71, wherein said calcium phosphate is selected from tricalcium phosphate, hydroxyapatite, poorly crystalline hydroxyapatite, amorphous calcium phosphate, calcium metaphosphate, dicalcium phosphate dihydrate, heptacalcium phosphate, calcium pyrophosphate dihydrate, calcium pyrophosphate, and octacalcium phosphate.
74. The implant material of claim 71, wherein said PDGF is provided in a sterile liquid.
75. The implant material of claim 74, wherein said liquid is sodium acetate buffer.
76. A method of preparing an implant material comprising saturating a calcium phosphate material in a sterile liquid comprising platelet-derived growth factor (PDGF) at a concentration in the range of about 0.1 mg/mL to about 1.0 mg/mL.
77. The method of claim 76, wherein the concentration of PDGF is about 0.3 mg/mL.
78. The method of claim 76, wherein said calcium phosphate is selected from tricalcium phosphate, hydroxyapatite, poorly crystalline hydroxyapatite, amorphous calcium phosphate, calcium metaphosphate, dicalcium phosphate dihydrate, heptacalcium phosphate, calcium pyrophosphate dihydrate, calcium pyrophosphate, and octacalcium phosphate.
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