Claims for Patent: 8,816,047

Summary for Patent: 8,816,047

Title:	Compositions and methods of using proislet peptides and analogs thereof
Abstract:	Embodiments relate to proislet peptides, preferably HIP, that exhibit increased stability and efficacy, and methods of using the same to treating a pathology associated with impaired pancreatic function, including type 1 and type 2 diabetes and symptoms thereof.
Inventor(s):	Levetan; Claresa S. (Rosemont, PA), Garsky; Victor M. (Blue Bell, PA), Upham; Loraine V. (Albuquerque, NM)
Assignee:	Cure DM Group Holdings, LLC (Wynnewood, PA)
Application Number:	12/674,573
Patent Claims:	1. A peptide consisting of the sequence of SEQ ID NO: 7 (HIP2B). 2. A pharmaceutical composition comprising a peptide consisting of the sequence of SEQ ID NO: 7 (HIP2B). 3. The pharmaceutical composition of claim 2, wherein said peptide is present in a therapeutically effective amount. 4. The pharmaceutical composition of claim 3, wherein said therapeutically effective amount is selected from the group consisting of about 20 mg and about 30-60 mg. 5. The pharmaceutical composition of claim 3, wherein said therapeutically effective amount is equivalent to a dose selected from a group consisting of about 0.5 to about 5 mg/kg, about 0.5 to about 1.0 mg/kg, about 0.1 mg/kg, about 0.5 mg/kg, about 1.0 mg/kg, about 5 mg/kg, and 8-20 mg/kilogram. 6. The pharmaceutical composition of claim 3, wherein the therapeutically effective amount is from about 400-800 mg per day, 60 to about 180 mg/day, or from about 60 to about 120 mg/day. 7. The pharmaceutical composition of claim 2 further comprising a pharmaceutically acceptable excipient. 8. A method of treating type 2 diabetes in a subject in need thereof comprising administering to the subject the peptide of claim 1. 9. A method of treating type 2 diabetes in a subject in need thereof comprising administering to the subject a pharmaceutical composition comprising a peptide consisting of the sequence of SEQ ID NO: 7 (HIP2B). 10. The method of claim 8, wherein said peptide is administered in a therapeutically effective amount. 11. The method of claim 9, wherein said pharmaceutical composition comprises a therapeutically effective amount of the peptide. 12. The method of claim 8, further comprising administering a pancreatic islet cell regeneration agent, wherein said agent is selected from the group consisting of amylin, pramlintide, exendin-4, GIP, GLP-1, GLP-1 receptor agonists, GLP-1 analogs, hamster INGAP peptide, liraglutide, dipeptidyl peptidase inhibitor and combinations thereof. 13. The method of claim 9, further comprising administering an agent selected from the group consisting of: teplizumab, abatacept, rapamycin, FK506, IL-2, aldesleukin, lisofylline (1-[(5R)-5-Hydroxyhexyl]-3,7-dimethyl-3,7-dihydro-1H-purine-2,6-dione), interferon-alpha, diazoxide, a statin, mycophenolate mofetil, daclizumab, rituximab; campath-1H, polyclonal anti-T-lymphocyte globulin, pegfilgrastim, vitamin D, anakinra, deoxyspergualin and combinations thereof. 14. The method of claim 13, wherein the statin is atorvastatin. 15. The method of claim 11, wherein the therapeutically effective amount is about 20 mg. 16. The method of claim 11, wherein the therapeutically effective amount is about 30 to about 60 mg. 17. The method of claim 11, wherein the therapeutically effective amount is equivalent to a dose selected from a group consisting of about 0.5 to about 5 mg/kg, about 0.5 to about 1.0 mg/kg, and about 8-20 mg/kilogram. 18. The method of claim 11, wherein the therapeutically effective amount is equivalent to a dose selected from a group consisting of about 0.1 mg/kg, about 0.5 mg/kg, about 1.0 mg/kg, and about 5 mg/kg. 19. The method of claim 11, wherein the therapeutically effective amount is from about 400 to about 800 mg/day, 60 to about 180 mg/day, or from about 60 to about 120 mg/day.

Details for Patent 8,816,047

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Clinigen, Inc.	PROLEUKIN	aldesleukin	For Injection	103293	05/05/1992		2027-08-30
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2027-08-30
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2027-08-30
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2027-08-30