NZ783621B2 - Compositions and methods for the treatment of wounds, disorders, and diseases of the skin - Google Patents
Compositions and methods for the treatment of wounds, disorders, and diseases of the skinInfo
- Publication number
- NZ783621B2 NZ783621B2 NZ783621A NZ78362116A NZ783621B2 NZ 783621 B2 NZ783621 B2 NZ 783621B2 NZ 783621 A NZ783621 A NZ 783621A NZ 78362116 A NZ78362116 A NZ 78362116A NZ 783621 B2 NZ783621 B2 NZ 783621B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- pharmaceutical composition
- hsv
- herpes simplex
- simplex virus
- polypeptide
- Prior art date
Links
Abstract
The present disclosure relates, in part, to pharmaceutical compositions comprising one or more polynucleotides suitable for enhancing, increasing, augmenting, and/or supplementing the levels of Collagen alpha-1 (VII) chain polypeptide and/or Lysyl hydroxylase 3 polypeptide and/or Keratin type I cytoskeletal 17 polypeptide in a subject. The present disclosure also relates, in part, to pharmaceutical compositions and methods of use for providing prophylactic, palliative, or therapeutic relief of a wound, disorder, or disease of the skin in a subject, including a subject having, or at risk of developing, one or more symptoms of epidermolysis bullosa.
Claims (35)
1. A pharmaceutical composition for delivery of a transgene to the skin of a subject comprising: a) a replication-defective herpes simplex virus (HSV) comprising a recombinant HSV genome, wherein the recombinant HSV genome comprises one or more polynucleotides encoding the transgene, wherein the replication-defective HSV is not a McKrae strain HSV; b) a pharmaceutically acceptable carrier; wherein the recombinant HSV genome comprises an inactivating mutation in the ICP22 herpes simplex virus gene and both copies of the ICP4 herpes simplex virus gene; and wherein the pharmaceutical composition is to be administered to one or more areas of the subject affected by a wound, disorder, or disease of the skin.
2. The pharmaceutical composition of claim 1, wherein the HSV is a herpes simplex type 1 virus (HSV-1) or a herpes simplex type 2 virus (HSV-2).
3. The pharmaceutical composition of claim 1 or claim 2, wherein the recombinant HSV genome comprises the one or more polynucleotides encoding the transgene in one or more viral gene loci.
4. The pharmaceutical composition of any one of claims 1-3, wherein the recombinant HSV genome comprises the one or more polynucleotides encoding the transgene in one or both of the ICP4 viral gene loci.
5. The pharmaceutical composition of any one of claims 1-4, wherein the recombinant HSV genome further comprises an inactivating mutation in a herpes simplex virus gene selected from the group consisting of ICP0, ICP27, ICP47, thymidine kinase (tk), long unique region (UL) 41, and UL55.
6. The pharmaceutical composition of any one of claims 1-5, wherein the inactivating mutation is a deletion of at least a portion of the coding sequence of the herpes simplex virus gene.
7. The pharmaceutical composition of claim 6, wherein the inactivating mutation is a deletion of at least a portion of the coding sequence of the ICP22 herpes simplex virus gene. 21794525_1 (GHMatters) P109671.NZ.2
8. The pharmaceutical composition of claim 6 or claim 7, wherein the inactivating mutation is a deletion of at least a portion of the coding sequence of the ICP4 herpes simplex virus gene.
9. The pharmaceutical composition of any one of claims 1-8, wherein the replication- defective HSV has reduced cytotoxicity as compared to a wild-type herpes simplex virus.
10. The pharmaceutical composition of any one of claims 1-9, wherein the subject is a human.
11. The pharmaceutical composition of any one of claims 1-10, wherein the one or more target cells are one or more keratinocytes and/or fibroblasts.
12. The pharmaceutical composition of any one of claims 1-11, wherein the HSV has been engineered to reduce cytotoxicity in keratinocytes and/or fibroblasts as compared to a wild- type HSV.
13. The pharmaceutical composition of any one of claims 1-12, wherein the pharmaceutical composition comprises at least 1 x 10 plaque forming units (PFU) of the HSV.
14. The pharmaceutical composition of any one of claims 1-13, wherein the pharmaceutically acceptable carrier is suitable for topical administration, transdermal administration, subcutaneous injection, intradermal injection, or any combinations thereof.
15. The pharmaceutical composition of any one of claims 1-14, wherein the one or more polynucleotides encode a Collagen alpha-1 (VII) chain polypeptide, a Lysyl hydroxylase 3 polypeptide, and/or a Keratin type I cytoskeletal 17 polypeptide.
16. The pharmaceutical composition of claim 15, wherein the Collagen alpha-1 (VII) chain polypeptide has at least 80% sequence identity to the sequence of SEQ ID NO: 2.
17. The pharmaceutical composition of claim 15, wherein the Lysyl hydroxylase 3 polypeptide has at least 80% sequence identity to the sequence of SEQ ID NO: 4.
18. The pharmaceutical composition of claim 15, wherein the Keratin type I cytoskeletal 17 polypeptide has at least 80% sequence identity to the sequence of SEQ ID NO: 30. 21794525_1 (GHMatters) P109671.NZ.2
19. The pharmaceutical composition of any one of claims 1-18, wherein the pharmaceutical composition comprises an ointment, paste, cream, suspension, emulsion, fatty ointment, gel, powder, lotion, solution, spray, patch, or microneedle array.
20. Use of a replication-defective herpes simplex virus (HSV) in the manufacture of a pharmaceutical composition for prophylactic, palliative, or therapeutic relief of a wound, disorder, or disease of the skin of a subject, wherein: the HSV comprises a recombinant HSV genome comprising one or more polynucleotides encoding a transgene; the replication-defective HSV is not a McKrae strain HSV; the recombinant HSV genome comprises an inactivating mutation in the ICP22 herpes simplex virus gene and both copies of the ICP4 herpes simplex virus gene; and the pharmaceutical composition is to be administered to one or more areas of the subject affected by a wound, disorder, or disease of the skin
21. The pharmaceutical composition of claim 20, wherein the HSV is a herpes simplex type 1 virus (HSV-1) or a herpes simplex type 2 virus (HSV-2).
22. The pharmaceutical composition of claim 20 or claim 21, wherein the recombinant HSV genome comprises the one or more polynucleotides encoding the transgene in one or more viral gene loci.
23. The pharmaceutical composition of any one of claims 20-22, wherein the recombinant HSV genome comprises the one or more polynucleotides encoding the transgene in one or both of the ICP4 viral gene loci.
24. The use of any one of claims 20-23, wherein the recombinant HSV genome further comprises an inactivating mutation in a herpes simplex virus gene selected from the group consisting of ICP0, ICP27, ICP47, thymidine kinase (tk), long unique region (UL) 41, and UL55.
25. The use of any one of claims 20-24, wherein the inactivating mutation is a deletion of at least a portion of the coding sequence of the herpes simplex virus gene. 21794525_1 (GHMatters) P109671.NZ.2
26. The use of claim 25, wherein the inactivating mutation is a deletion of at least a portion of the coding sequence of the ICP22 herpes simplex virus gene.
27. The use of claim 25 or claim 26, wherein the inactivating mutation is a deletion of at least a portion of the coding sequence of the ICP4 herpes simplex virus gene.
28. The use of any one of claims 20-27, wherein the HSV has reduced cytotoxicity as compared to a wild-type herpes simplex virus.
29. The use of any one of claims 20-28, wherein the subject is a human.
30. The use of any one of claims 20-29, wherein the one or more target cells are one or more keratinocytes and/or fibroblasts.
31. The use of any one of claims 20-30, wherein the HSV has been engineered to reduce cytotoxicity in keratinocytes and/or fibroblasts as compared to a wild-type HSV.
32. The use of any one of claims 20-31, wherein the one or more polynucleotides encode a Collagen alpha-1 (VII) chain polypeptide, a Lysyl hydroxylase 3 polypeptide, and/or a Keratin type I cytoskeletal 17 polypeptide.
33. The use of any one of claims 20-32, wherein the pharmaceutical composition is to be administered topically, transdermally, subcutaneously, or intradermally to the subject.
34. The use of any one of claims 20-33, wherein the disease or disorder of the skin is epidermolysis bullosa.
35. The use of any one of claims 20-34, wherein the disease or disorder of the skin is dystrophic epidermolysis bullosa. 21794525_1 (GHMatters) P109671.NZ.2
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662320316P | 2016-04-08 | 2016-04-08 | |
| NZ778381A NZ778381B2 (en) | 2016-12-28 | Compositions and methods for the treatment of wounds, disorders, and diseases of the skin |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ783621A NZ783621A (en) | 2025-06-27 |
| NZ783621B2 true NZ783621B2 (en) | 2025-09-30 |
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