# US 11,078,244 B2 · Composition and method for delivery of BMP-2 amplifler/co-activator for enhancement of osteogenesis

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- Number: US 11,078,244 B2
- Document ID: US11078244B2
- Status: Granted
- Kind: B2
- Application number: 16/358,343
- Filed: 2019-03-19
- Published: 2019-10-24
- Granted: 2021-08-03
- Earliest claimed: 2006-06-22
- Assignees: Ferring B.V.; Brookhaven Science Associates, LLC
- Applicants: Ferring B.V.; Brookhaven Science Associates, LLC
- Inventors: Paul Zamora; Brent Lee Atkinson; Xinhua Lin; Louis A. Pena
- Web page: https://patentgrep.com/patent/US11078244B2

## CPC

- C07K 14/4705: {stimulating, promoting or activating activity}
- A61K 38/1875: {Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor}
- A61L 27/12: Phosphorus-containing materials, e.g. apatite
- A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/22: Polypeptides or derivatives thereof {, e.g. degradation products}
- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 27/24: Collagen
- A61L 27/34: Macromolecular materials
- A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)}
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- C07K 14/51: Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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 (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A composition comprising a synthetic growth factor analogue comprising a non-growth factor heparin binding region, a linker and a sequence that binds specifically to a cell surface receptor and an osteoconductive material where the synthetic growth factor analogue is attached to and can be released from the osteoconductive material and is an amplifier/co-activator of osteoinduction.

## Claims

### Claim 1

A method for preparing an implantable bone graft material comprising:
forming an aqueous solution comprising a synthetic growth factor analogue having the structure
wherein Hx is 6-aminohexanoic acid; and
mixing the aqueous solution with an osteoconductive material, thereby binding a therapeutically effective amount of the synthetic growth factor analog to the osteoconductive material.

### Claim 2 (depends on 1)

The method of claim 1, wherein the osteoconductive material comprises 60-20 wt % hydroxyapatite and 80-40 wt % tricalcium phosphate.

### Claim 3 (depends on 1)

The method of claim 1, wherein the osteoconductive material comprises 60 wt % hydroxyapatite and 40 wt % tricalcium phosphate.

### Claim 4 (depends on 1)

The method of claim 1, wherein the osteoconductive material comprises 20 wt % hydroxyapatite and 80 wt % tricalcium phosphate.

### Claim 5 (depends on 1)

The method of claim 1, wherein the osteoconductive material is formed into a granule.

### Claim 6 (depends on 5)

The method of claim 5, wherein the synthetic growth factor analogue is bound to the osteoconductive material to yield a concentration ranging from 43 to 431 μg/cc granule.

### Claim 7 (depends on 5)

The method of claim 5, wherein the synthetic growth factor analogue is bound to the osteoconductive material to yield a concentration ranging from 143 to 431 μg/cc granule.

### Claim 8 (depends on 1)

The solution of claim 1, wherein the aqueous solution further comprises mannitol.

### Claim 9 (depends on 1)

The solution of claim 1, wherein the aqueous solution further comprises mannitol and glycine.

### Claim 10 (depends on 1)

The method of claim 1, wherein the concentration of synthetic growth factor analogue in the aqueous solution ranges from 36 to 1,072 μg/mL.

### Claim 11 (depends on 1)

The method of claim 1, wherein the concentration of synthetic growth factor analogue in the aqueous solution ranges from 36 to 359 μg/mL.

### Claim 12

A method for preparing an implantable bone graft material comprising:
forming an aqueous solution comprising mannitol and a synthetic growth factor analogue having the structure
wherein Hx is 6-aminohexanoic acid; and
lyophilizing the solution to yield a lyophilized solid.

### Claim 13 (depends on 12)

The method of claim 12, wherein the solution further comprises glycine.

### Claim 14 (depends on 12)

The method of claim 12, wherein the method further comprises forming a second aqueous solution from the lyophilized solid, the second aqueous solution having a concentration of synthetic growth factor analogue ranging from 36 to 1,072 μg/mL.

### Claim 15 (depends on 12)

The method of claim 12, wherein the method further comprises forming a second aqueous solution from the lyophilized solid, the second aqueous solution having a concentration of synthetic growth factor analogue ranging from 36 to 359 μg/mL.