# US 8,785,400 B2 · Methods and compositions relating to islet cell neogenesis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,785,400 B2 - Document ID: US8785400B2 - Status: Granted - Kind: B2 - Application number: 11/943,991 - Filed: 2007-11-21 - Published: 2009-03-12 - Granted: 2014-07-22 - Earliest claimed: 2006-11-22 - Assignees: CureDM Group Holdings, LLC - Applicants: Claresa S. Levetan; Loraine V. Upham - Inventors: Claresa S. Levetan; Loraine V. Upham - Web page: https://patentgrep.com/patent/US8785400B2 ## CPC - A61K 38/10: Peptides having 12 to 20 amino acids {(A61K38/043 - A61K38/046 take precedence)} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes - A61P 3/04: Anorexiants; Antiobesity agents - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61P 35/00: Antineoplastic agents - A61P 37/04: Immunostimulants - C07K 16/2809: {against the T-cell receptor (TcR)-CD3 complex} - A61K 2039/505: {comprising antibodies} - 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 - 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) ## Abstract The present invention provides methods and kits for treating diseases and conditions associated with impaired pancreatic function. The present invention further provides methods of stimulating islet cell neogenesis and stimulating islet cell differentiation from progenitor cells. ## Claims ### Claim 1 A method of stimulating islet cell neogenesis in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a peptide consisting of the amino acid sequence of SEQ ID NO. 4, Human proIslet Peptide 2 (HIP2). ### Claim 2 (depends on 1) The method of claim 1, further comprising administering a therapeutically effective amount of an agent selected from the group consisting of: an immune therapy agent and an additional agent that stimulates islet cell regeneration. ### Claim 3 (depends on 2) The method of claim 2, wherein said immune therapy agent is selected from the group consisting of: anti-CD3 antibodies, sirolimus, tacrolimus, a heat-shock protein 60, an anti-glutamic acid decarboxylase 65 antibody, mycophenolate mofetil alone or in combination with daclizumab, an anti-CD20 agent, rituximab, campath-1H, lysofylline, vitamin D, IBC-VSO vaccine, interferon-alpha, and a vaccine using CD4+CD25+ antigen-specific regulatory T cells. ### Claim 4 (depends on 2) The method of claim 2, wherein said additional agent that stimulates islet cell regeneration is selected from the group consisting of: a Human ProIslet Peptide (HIP) or a HIP-related peptide, amylin, pramlintide, insulin, exendin-4, GIP, GLP-1, GLP-1 receptor agonists, GLP-1 analogs, hamster INGAP peptide and related peptides, liraglutide, and a dipeptidyl peptidase inhibitor which blocks the degradation of GLP-1. ### Claim 5 A method of treating a disease or condition associated with impaired pancreatic function in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a peptide consisting of the amino acid sequence of SEQ ID NO. 4, Human prolslet Peptide 2 (HIP2). ### Claim 6 (depends on 5) The method of claim 5 wherein said disease or condition associated with impaired pancreatic function is selected from the group consisting of: type 1 diabetes, new onset type 1 diabetes, type 2 diabetes, Latent Autoimmune Diabetes in Adults, pre-diabetes, impaired fasting glucose, fasting hyperinsulinemia, impaired glucose tolerance, insulin resistant syndrome, insulin deficiency, metabolic syndrome, obesity, anorexia, bulimia, neuropathic pain, pancreatitis, pancreatic cancer, hyperlipidemia, hypertriglyceridemia, eating disorders, anovulatory cycles, lack of or diminished insulin production resulting in aberrant glucose metabolism, and polycystic ovarian syndrome. ### Claim 7 (depends on 6) The method of claim 6, wherein said disease or condition associated with impaired pancreatic function is selected from the group consisting of: type 1 diabetes, type 2 diabetes, Latent Autoimmune Diabetes in Adults, pre-diabetes, and metabolic syndrome. ### Claim 8 (depends on 5) The method of claim 5, further comprising administering a therapeutically effective amount of an agent selected from the group consisting of: an immune therapy agent and an additional agent that stimulates islet cell regeneration. ### Claim 9 (depends on 8) The method of claim 8, wherein said immune therapy is selected from the group consisting of: anti-CD3 antibodies, sirolimus, tacrolimus, a heat-shock protein 60, an anti-glutamic acid decarboxylase 65 antibody, mycophenolate mofetil alone or in combination with daclizumab, an anti-CD20 agent, rituxirnab, campath-1H, lysofylline, vitamin D, IBC-VSO vaccine, interferon-alpha, and a vaccine using CD4+CD25+ antigen-specific regulatory T cells. ### Claim 10 (depends on 8) The method of claim 8, wherein said additional agent that stimulates islet cell regeneration is selected from the group consisting of: a Human Prolslet Peptide (HIP) or a HIP-related peptide, amylin, pramlintide, insulin, exendin-4, GIP, GLP-1, GLP-1 receptor agonists, GLP-1 analogs, hamster INGAP peptide and related peptides, liraglutide, and a dipeptidyl peptidase inhibitor which blocks the degradation of GLP-1. ### Claim 11 (depends on 8) The method of claim 8, wherein said disease or condition associated with impaired pancreatic function is selected from the group consisting of: type 1 diabetes, new onset type 1 diabetes, type 2 diabetes, Latent Autoimmune Diabetes in Adults, pre-diabetes, impaired fasting glucose, fasting hyperinsulinemia, impaired glucose tolerance, insulin resistant syndrome, insulin deficiency, metabolic syndrome, obesity, anorexia, bulimia, neuropathic pain, pancreatitis, pancreatic cancer, hyperlipidemia, hypertriglyceridemia, eating disorders, anovulatory cycles, lack of or diminished insulin production resulting in aberrant glucose metabolism, and polycystic ovarian syndrome. ### Claim 12 (depends on 11) The method of claim 11, wherein said disease or condition associated with impaired pancreatic function is selected from: type 1 diabetes, type 2 diabetes, Latent Autoimmune Diabetes in Adults, pre-diabetes, and metabolic syndrome. ### Claim 13 A method of reducing insulin requirements in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of a peptide consisting of the amino acid sequence of SEQ ID NO. 4, Human proIslet Peptide 2 (HIP2). ### Claim 14 (depends on 13) The method of claim 13, further comprising administering a therapeutically effective amount of an agent selected from the group consisting of: an immune therapy agent and an additional agent that stimulates islet cell regeneration. ### Claim 15 (depends on 14) The method of claim 14, wherein said immune therapy is selected from the group consisting of: anti-CD3 antibodies, sirolimus, tacrolimus, a heat-shock protein 60, an anti-glutamic acid decarboxylase 65 antibody, mycophenolate mofetil alone or in combination with daclizumab, an anti-CD20 agent, rituximab, campath-1H, lysofylline, vitamin D, IBC-VSO vaccine, interferon-alpha, and a vaccine using CD4+CD25+ antigen-specific regulatory T cells. ### Claim 16 (depends on 14) The method of claim 14, wherein said additional agent that stimulates islet cell regeneration is selected from: a Human ProIslet Peptide (HIP) or a HIP-related peptide, amylin, pramlintide, insulin, exendin-4, GIP, GLP-1, GLP-1 receptor agonists, GLP-1 analogs, hamster INGAP peptide and related peptides, liraglutide, and a dipeptidyl peptidase inhibitor which blocks the degradation of GLP-1.