# US 12,109,324 B2 · Compositions for treating wounds

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- Number: US 12,109,324 B2
- Document ID: US12109324B2
- Status: Granted
- Kind: B2
- Application number: 16/698,245
- Filed: 2019-11-27
- Published: 2020-05-28
- Granted: 2024-10-08
- Earliest claimed: 2014-10-14
- Applicants: Samuel E. Lynch
- Inventors: Samuel E. Lynch; Leslie Wisner-Lynch
- Web page: https://patentgrep.com/patent/US12109324B2

## CPC

- A61L 26/0066: {Medicaments; Biocides}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K 38/1858: {Platelet-derived growth factor [PDGF]}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61L 26/0023: {Polysaccharides}
- A61L 26/0033: {Collagen}
- A61L 26/0052: {Mixtures of macromolecular compounds}
- A61L 26/0085: {Porous materials, e.g. foams or sponges}
- A61L 26/0095: {Composite materials, i.e. containing one material dispersed in a matrix of the same or different material}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61L 2300/414: Growth factors
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Novel compositions for treating wounds and promoting the healing thereof are described, including composition containing novel combinations of a carrier and recombinant platelet derived growth factor having fewer isoforms and enhanced biostability. Methods of treating wounds with novel therapeutic composition using doing procedures leading to effective results with a minimal number of treatment applications are also described.

## Claims

### Claim 1

A lyophilized therapeutic composition consisting essentially of recombinant human platelet-derived growth factor (rhPDGF) B chain homodimer (rhPDGF-BB), incorporated into a biocompatible matrix, wherein the lyophilized therapeutic composition is formed from a rhPDGF-BB solution disposed in a porous biocompatible matrix,
wherein:
(a) the rhPDGF-BB solution contains between about 0.05 mg/ml to about 5 mg/ml of rhPDGF-BB in a buffer;
(b) the porous biocompatible matrix consists of a natural polymer selected from the group consisting of collagen, gelatin, fibrin, alginate, cellulose, chitosan and fibronectin;
(c) the porous biocompatible matrix includes an open porous structure that allows for cell attachment and ingrowth into said pores, wherein the pores have a pore size distribution of between 50 μm and 1000 μm, or an average pore size of between 50 μm and 500 μm, and wherein said pores entrap at least 50% of said rhPDGF-BB within said pores;
(d) the ratio of the rhPDGF-BB solution to the matrix is between about 0.05 ml/cm3 to about 5 ml/cm3;
(e) upon wetting with a physiologic solution, the lyophilized therapeutic composition yields a ratio of the rhPDGF-BB to the matrix that is between about 75 μg PDGF/cm3 of matrix to about 225 μg PDGF/cm3 of matrix; and
(f) the lyophilized therapeutic composition is biostable and retains at least 80% of its bioactivity when stored for at least six months.

### Claim 2 (depends on 1)

The composition of claim 1, wherein at least 80% of the rhPDGF-BB on a weight basis is unclipped rhPDGF-BB.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the rhPDGF-BB is produced through an E. coli expression system.

### Claim 4 (depends on 1)

The composition of claim 1, wherein said matrix er carrier has pores, and said pores have pore sizes ranging from about 50 μm to about 1000 μm.

### Claim 5 (depends on 1)

The composition of claim 1, wherein said matrix of carrier has pores, and said pores have pore sizes ranging from about 100 μm to about 500 μm.

### Claim 6 (depends on 1)

The composition of claim 1, wherein a majority of the pores within the matrix are interconnected.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the matrix is an insoluble collagen sponge or insoluble collagen wound dressing.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the physiologic solution is sterile water, saline, or a buffer.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the composition is adapted for treating wounds by having a ratio of the rhPDGF-BB to the matrix that is between 75 μg PDGF/cm3 of matrix to 225 μg PDGF/cm3 of matrix, upon wetting with the physiologic solution.