Claims for Patent: 8,785,400

Summary for Patent: 8,785,400

Title:	Methods and compositions relating to islet cell neogenesis
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.
Inventor(s):	Levetan; Claresa S. (Rosemont, PA), Upham; Loraine V. (Albuquerque, NM)
Assignee:	CureDM Group Holdings, LLC (Wilmington, DE)
Application Number:	11/943,991
Patent Claims:	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). 2. 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. 3. 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.sup.+CD25.sup.+ antigen-specific regulatory T cells. 4. 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. 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). 6. 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. 7. 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. 8. 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. 9. 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.sup.+CD25.sup.+ antigen-specific regulatory T cells. 10. 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. 11. 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. 12. 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. 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). 14. 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. 15. 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.sup.+CD25.sup.+ antigen-specific regulatory T cells. 16. 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.

Details for Patent 8,785,400

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2026-11-22
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2026-11-22
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Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2026-11-22
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2026-11-22