Claims for Patent: 9,321,812

Summary for Patent: 9,321,812

Title:	Insulin independence among patients with diabetes utilizing an optimized hamster REG3 gamma peptide
Abstract:	Embodiments of the present invention provide for novel therapies, pharmaceutical compositions and methods for insulin independence utilizing a new optimized hamster Reg3 gamma peptide, which is new to the art and has not previously been considered for development in the 30 year history since its discovery. Methods, pharmaceutical compositions and therapies novel to the prior art are utilized in this invention to render patients with recent onset and existing type 1 diabetes insulin independent by an optimized hamster Reg3 gamma peptide and an immune tolerance agent for type 1 patients to become insulin independent and used alone without an immune tolerance agent for type 2 diabetes. While not wishing to be bound by theory, optimized Reg3 gamma peptides increases beta cell generation by its demonstrated properties shown within of transforming ductal pancreatic cells into new islets.
Inventor(s):	Levetan; Claresa (Bryn Mawr, PA)
Assignee:	Perle Bioscience (Charleston, SC)
Application Number:	14/453,414
Patent Claims:	1. A pharmaceutical composition comprising a peptide comprising SEQ ID NO: 2. 2. The pharmaceutical composition of claim 1, further comprising: an immune tolerance agent selected from the group consisting of: a. Cyclosporine A, b. hOKT3.gamma.1(Ala-Ala), c. ChAglyCD3, d. Sirolimus (Rapamycin), e. Tacrolimus (FK506), f. a heat-shock protein 60 (Diapep277), g. anti-Glutamic Acid Decarboxylase 65 (GAD65) vaccine, h. Mycophenolate Mofetil alone or in combination with Daclizumab, i. anti-CD20 agent (Rituximab), j. Campath-1H (Anti-CD52 Antibody), k. antithymocyte globulin (ATG), l. Vitamin D, m. IBC-VSO vaccine, n. interferon-alpha, o. vaccine using CD4+CD25+ antigen-specific regulatory T cells, and p. Lysofylline. 3. The pharmaceutical composition of claim 1, wherein a N-terminus or a C-terminus of said SEQ ID NO:2 is covalently bonded to a dimeric maleimide activated 40 Kd PEG construct. 4. A composition comprising a peptide comprising SEQ ID NO:2 in a pharmaceutically acceptable carrier. 5. The composition of claim 4, further comprising: an immune tolerance agent selected from the group consisting of: a. Cyclosporine A, b. hOKT3.gamma.1(Ala-Ala), c. ChAglyCD3, d. Sirolimus (Rapamycin), e. Tacrolimus (FK506), f. a heat-shock protein 60 (Diapep277), g. anti-Glutamic Acid Decarboxylase 65 (GAD65) vaccine, h. Mycophenolate Mofetil alone or in combination with Daclizumab, i. anti-CD20 agent (Rituximab), j. Campath-1H (Anti-CD52 Antibody), k. antithymocyte globulin (ATG), l. Vitamin D, m. IBC-VSO vaccine, n. interferon-alpha, o. vaccine using CD4+CD25+ antigen-specific regulatory T cells, and p. Lysofylline. 6. The composition of claim 5, wherein the immune tolerance agent is Cyclosporine. 7. The composition of claim 4, wherein the composition is formulated for systemic administration. 8. The composition of claim 4, wherein the composition comprises a targeting agent for targeted administration to specific locations, receptors, cells, tissues, organs, or organ systems. 9. The pharmaceutical composition of claim 4, wherein the N-terminus or C-terminus is covalently bonded to a dimeric maleimide activated 40 Kd PEG construct. 10. The composition of claim 5, wherein the composition is formulated for systemic administration. 11. The composition of claim 5, wherein the composition comprises a targeting agent for targeted administration to specific locations, receptors, cells, tissues, organs, or organ systems. 12. The pharmaceutical composition of claim 2, wherein the immune tolerance agent is Cyclosporine. 13. The pharmaceutical composition of claim 1, wherein the composition is formulated for systemic administration. 14. The pharmaceutical composition of claim 1, wherein the composition comprises a targeting agent for targeted administration to specific locations, receptors, cells, tissues, organs, or organ systems. 15. The pharmaceutical composition of claim 2, wherein the composition is formulated for systemic administration. 16. The pharmaceutical composition of claim 2, wherein the composition comprises a targeting agent for targeted administration to specific locations, receptors, cells, tissues, organs, or organ systems.

Details for Patent 9,321,812

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-02-26
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-02-26
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2039-02-26
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2039-02-26
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2039-02-26
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2039-02-26
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2039-02-26