Claims for Patent: 7,989,415

Summary for Patent: 7,989,415

Title:	Peptides, derivatives and analogs thereof, and methods of using same
Abstract:	Human proIslet Peptides (HIP) and HIP analogs and derivatives thereof, derived from or homologous in sequence to the human REG3A protein, chromosome 2p12, are able to induce islet neogenesis from endogenous pancreatic progenitor cells. Human proIslet Peptides are used either alone or in combination with other pharmaceuticals in the treatment of type 1 and type 2 diabetes and other pathologies related to aberrant glucose, carbohydrate, and/or lipid metabolism, insulin resistance, overweight, obesity, polycystic ovarian syndrome, eating disorders and the metabolic syndrome.
Inventor(s):	Levetan; Claresa S. (Bryn Mawr, PA), Upham; Loraine V. (Mt. Laurel, NJ)
Assignee:	CureDM Group Holdings, LLC (Wilmington, DE)
Application Number:	12/635,053
Patent Claims:	1. A method of treating a pathology associated with impaired pancreatic function selected from pre-diabetes, type 2 diabetes, latent autoimmune diabetes, and hyperglycemia in a subject in need thereof comprising: administering to the subject a therapeutically effective amount of a human proislet peptide consisting of the amino acid sequence selected from SEQ ID No. 3, SEQ ID No: 7 and a combination thereof. 2. The method of claim 1 further comprising the step of administering one or more agents for stimulating pancreatic islet cell regeneration. 3. The method of claim 2, wherein the agent for stimulating pancreatic islet cell regeneration is selected from a member of the group consisting of human proislet peptide, amylin, pramlinitide, exendin-4, liraglutide, GLP-1 receptor agonists, GLP-1, hamster INGAP, GIP, dipeptydyl peptidase-4 inhibitors and analogs thereof. 4. The method of claim 1 further comprising the step of administering one or more agents that inhibit autoimmune cells that target pancreatic islet cells. 5. The method of claim 4, wherein the agent that inhibits the autoimmune cells that target pancreatic islet cells is selected from the group consisting of anti-CD3 antibody, rapamycin, FK506, heat-shock protein, tacrolimus, GAD65 vaccine, mycophenolate mofetil, lysofylline, rituximab, daclizumab, anti-CD52 antibody, anti-CD20 antibody, Vitamin D, IBC-VSO vaccine, interferon alpha and CD4.sup.+CD25.sup.+ antigen-specific regulatory T cells. 6. The method of claim 5, wherein the vitamin D is vitamin D3. 7. The method of claim 6, wherein the vitamin D3 is administered to the subject in an amount effective to maintain 25-hydroxy vitamin D above about 40 ng/mL in the subject. 8. The method of claim 1, wherein at least one symptom of the pathology associated with impaired pancreatic function is treated as a result of the administration of at least one human proislet peptide. 9. The method of claim 8, wherein the symptom is selected from a member of the group consisting of frequent urination, excessive thirst, extreme hunger, unusual weight loss, increased fatigue, irritability, blurry vision, genital itching, odd aches and pains, dry mouth, dry or itchy skin, impotence, vaginal yeast infections, poor healing of cuts and scrapes, excessive or unusual infections, hyperglycemia, loss of glycemic control, fluctuations in postprandial blood glucose, fluctuations in blood glucagons and fluctuations in blood triglycerides. 10. The method of claim 1, wherein the subject is a mammal. 11. The method of claim 10, wherein the mammal is selected from a human, a horse, a cow, a sheep, a dog and a cat. 12. The method of claim 1, wherein the peptide is SEQ ID No. 3. 13. The method of claim 1, wherein the peptide is SEQ ID No. 7. 14. The method of claim 1, wherein the peptide is administered in a pharmaceutical composition. 15. The method of claim 1, wherein the peptide is administered to said subject by a route selected from orally, subcutaneously, transdermally, intranasally, parenterally, topically and buccally. 16. The method of claim 1 further comprising administering insulin. 17. The method of claim 1, wherein said human proislet peptide is conjugated to a compound selected from albumin, transferrin and polyethylene glycol. 18. A method of treating type 1 diabetes comprising administering a human proislet peptide consisting of the amino acid sequence SEQ ID No. 3. 19. The method of claim 18 further comprising the step of administering one or more agents for stimulating pancreatic islet cell regeneration. 20. The method of claim 18, wherein the agent for stimulating pancreatic islet cell regeneration is selected from a member of the group consisting of human proislet peptide, amylin, pramlinitide, exendin-4, liraglutide, GLP-1 receptor agonists, GLP-1, hamster INGAP, GIP, dipeptydyl peptidase-4 inhibitors and analogs thereof. 21. The method of claim 18 further comprising the step of administering one or more agents that inhibit autoimmune cells that target pancreatic islet cells. 22. The method of claim 21, wherein the agent that inhibits the autoimmune cells that target pancreatic islet cells is selected from the group consisting of anti-CD3 antibody, rapamycin, FK506, heat-shock protein, tacrolimus, GAD65 vaccine, mycophenolate mofetil, lysofylline, rituximab, daclizumab, anti-CD52 antibody, anti-CD20 antibody, Vitamin D, IBC-VSO vaccine, interferon alpha and CD4.sup.+CD25.sup.+ antigen-specific regulatory T cells. 23. The method of claim 22, wherein the vitamin D is vitamin D3. 24. The method of claim 23, wherein the vitamin D3 is administered to the subject in an amount effective to maintain 25-hydroxy vitamin D above about 40 ng/mL in the subject. 25. The method of claim 18, wherein at least one symptom of type 1 diabetes is treated as a result of the administration of the peptide. 26. The method of claim 25, wherein the symptom is selected from a member of the group consisting of frequent urination, excessive thirst, extreme hunger, unusual weight loss, increased fatigue, irritability, blurry vision, genital itching, odd aches and pains, dry mouth, dry or itchy skin, impotence, vaginal yeast infections, poor healing of cuts and scrapes, excessive or unusual infections, hyperglycemia, loss of glycemic control, fluctuations in postprandial blood glucose, fluctuations in blood glucagons and fluctuations in blood triglycerides. 27. The method of claim 18, wherein the subject is a mammal. 28. The method of claim 27, wherein the mammal is selected from a human, a horse, a cow, a sheep, a dog and a cat. 29. The method of claim 18, wherein the peptide is administered in a pharmaceutical composition. 30. The method of claim 18, wherein the peptide is administered to said subject by a route selected from orally, subcutaneously, transdermally, intranasally, parenterally, topically and buccally. 31. The method of claim 18 further comprising administering insulin. 32. The method of claim 18, wherein said human proislet peptide is conjugated to a compound selected from albumin, transferrin and polyethylene glycol.

Details for Patent 7,989,415

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2025-05-25
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2025-05-25
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2025-05-25