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US 12,497,663 B2Granted
Method of monitoring treatment
AssigneeLDN Pharma Limited
InventorWai Liu
Life of this patent
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Abstract
The invention relates to a method for monitoring the treatment of a subject undergoing therapy with an active that is naltrexone or a metabolite or analogue thereof, comprising: measuring the gene expression profile of any of the genes listed in Table 1 or Table 2, in a sample of CD3+ cells obtained from the subject undergoing treatment; wherein if the expression of any of the genes in Table 1 is increased compared to a control, or if any of the genes listed in Table 2 is decreased compared to a control the active is being administered at an effective level.
Claims20
A method for the treatment of a subject, comprising:
- (i) administering an active that is naltrexone or a metabolite or analogue thereof, wherein the metabolite or analogue is 6-β-naltrexol, naloxone or methylnaltrexone, and
- (ii) if the gene expression profile of any of the genes listed in a) in a sample of CD3+ cells obtained from the subject undergoing treatment is increased compared to a control, or if any of the genes listed in b) in a sample of CD3+ cells obtained from the subject undergoing treatment is decreased compared to a control, administering a further treatment drug to the subject,
- wherein a) is:
- a) i. S100 calcium binding protein A6, mRNA;
- ii. RAS protein activator like 3, mRNA;
- iii. Mitogen-activated protein kinase kinase kinase kinase 1, mRNA;
- iv. Tyrosine 3-monooxygenase/tryptophan 5-monooxygenase, mRNA;
- v. DR1-associated protein 1 (negative cofactor alpha 2), mRNA;
- vi. Castor zinc finger 1, transcript variant 2, mRNA;
- vii. Aldehyde dehydrogenase 4 family, member A1, mRNA;
- viii. Phenylalanine hydroxylase, mRNA;
- ix. Myosin, light polypeptide kinase, transcript variant 5, mRNA;
- x. Eukaryotic translation initiation factor 4B, mRNA;
- xi. Olfactory receptor, family 10, subfamily A, member 6, mRNA;
- xii. Ezrin, transcript variant 1, mRNA;
- xiii. Actin, beta, mRNA;
- xiv. PRP8 pre-mRNA processing factor 8 homolog (S. cerevisiae),mRNA;
- xv. Integrin, beta 2 (complement component 3 receptor 3 and 4),mRNA;
- xvi. Hippocalcin-like 1, transcript variant 2, mRNA;
- xvii. Sparc/osteonectin, cwcv and kazal-like domains proteoglycan 2, mRNA;
- xviii. Poliovirus receptor-related 2 (herpesvirus entry mediator B), mRNA;
- or
- xix. Nucleobindin 1, mRNA;
- and b) is:
- b) i. WD repeat domain 75, mRNA;
- ii. Baculoviral IAP repeat-containing 3, transcript variant, mRNA;
- iii. CDKN2A interacting protein, mRNA;
- iv. Dynein, light chain, LC8-type 2, mRNA;
- v. Eukaryotic translation initiation factor 2, subunit 3 gamma, mRNA;
- vi. Potassium channel tetramerisation domain containing 6, mRNA;
- vii. Proteasome (prosome, macropain) activator subunit 2, mRNA;
- viii. Mortality factor 4 like 1, transcript variant 2, mRNA;
- ix. Metal-regulatory transcription factor 1, mRNA;
- x. Peroxisomal D3,D2-enoyl-CoA isomerase, transcript, mRNA;
- xi. Programmed cell death 4 (neoplastic transformation inhibitor),mRNA;
- xii. Histone cluster 1, H4c, mRNA;
- xiii. BCL2-associated transcription factor 1, transcript variant, mRNA;
- xiv. Eukaryotic translation initiation factor 3, subunit E, mRNA;
- xv. LSM5 homolog, U6 small nuclear RNA associated (S. cerevisiae),mRNA;
- xvi. H3 histone, family 3A, mRNA;
- xvii. Eukaryotic translation initiation factor 3, subunit M, mRNA;
- or
- xviii. CDC42 small effector 2, transcript variant 2, mRNA;
- in a sample of CD3+ cells obtained from the subject undergoing treatment.
41 more elements
A method for the treatment of a subject, comprising:
- (i) administering an active that is naltrexone or a metabolite or analogue thereof, wherein the metabolite or analogue is 6-β-naltrexol, naloxone or methylnaltrexone, and
- (ii) if the gene expression profile of any of the genes listed in a) in a sample of CD3+ cells obtained from the subject undergoing treatment is not increased compared to a control, or if any of the genes listed in b) in a sample of CD3+ cells obtained from the subject undergoing treatment is not decreased compared to a control, re-administering the active to the subject, wherein a) is:
- a) i. S100 calcium binding protein A6, mRNA;
- ii. RAS protein activator like 3, mRNA;
- iii. Mitogen-activated protein kinase kinase kinase kinase 1, mRNA;
- iv. Tyrosine 3-monooxygenase/tryptophan 5-monooxygenase, mRNA;
- v. DR1-associated protein 1 (negative cofactor alpha 2), mRNA;
- vi. Castor zinc finger 1, transcript variant 2, mRNA;
- vii. Aldehyde dehydrogenase 4 family, member A1, mRNA;
- viii. Phenylalanine hydroxylase, mRNA;
- ix. Myosin, light polypeptide kinase, transcript variant 5, mRNA;
- x. Eukaryotic translation initiation factor 4B, mRNA;
- xi. Olfactory receptor, family 10, subfamily A, member 6, mRNA;
- xii. Ezrin, transcript variant 1, mRNA;
- xiii. Actin, beta, mRNA;
- xiv. PRP8 pre-mRNA processing factor 8 homolog (S. cerevisiae),mRNA;
- xv. Integrin, beta 2 (complement component 3 receptor 3 and 4),mRNA;
- xvi. Hippocalcin-like 1, transcript variant 2, mRNA;
- xvii. Sparc/osteonectin, cwcv and kazal-like domains proteoglycan 2, mRNA;
- xviii. Poliovirus receptor-related 2 (herpesvirus entry mediator B), mRNA;
- or
- xix. Nucelobindin 1, mRNA;
- and b) is:
- b) i. WD repeat domain 75, mRNA;
- ii. Baculoviral IAP repeat-containing 3, transcript variant, mRNA;
- iii. CDKN2A interacting protein, mRNA;
- iv. Dynein, light chain, LC8-type 2, mRNA;
- v. Eukaryotic translation initiation factor 2, subunit 3 gamma, mRNA;
- vi. Potassium channel tetramerisation domain containing 6, mRNA;
- vii. Proteasome (prosome, macropain) activator subunit 2, mRNA;
- viii. Mortality factor 4 like 1, transcript variant 2, mRNA;
- ix. Metal-regulatory transcription factor 1, mRNA;
- x. Peroxisomal D3,D2-enoyl-CoA isomerase, transcript, mRNA;
- xi. Programmed cell death 4 (neoplastic transformation inhibitor),mRNA;
- xii. Histone cluster 1, H4c, mRNA;
- xiii. BCL2-associated transcription factor 1, transcript variant, mRNA;
- xiv. Eukaryotic translation initiation factor 3, subunit E, mRNA;
- xv. LSM5 homolog, U6 small nuclear RNA associated (S. cerevisiae),mRNA;
- xvi. H3 histone, family 3A, mRNA;
- xvii. Eukaryotic translation initiation factor 3, subunit M, mRNA;
- or
- xviii. CDC42 small effector 2, transcript variant 2, mRNA;
- in a sample of CD3+ cells obtained from the subject undergoing treatment.
40 more elements
Dependencies are inferred from the claim text.