Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2006-11-09
2010-06-29
Landsman, Robert (Department: 1647)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S002600, C530S308000
Reexamination Certificate
active
07745403
ABSTRACT:
GLP-2 analogues are disclosed which comprise one of more substitutions as compared to [hGly2]GLP-2 and which improved biological activity in vivo and/or improved chemical stability, e.g., as assessed in in vitro stability assays. More particularly, preferred GLP-2 analogues disclosed herein comprise substitutions at one or more of positions 8, 16, 24 and/or 28 of the wild-type GLP-2 sequence, optionally in combination with further substitutions at position 2 (as mentioned in the introduction) and one or more of positions 3, 5, 7, 10 and 11, and/or a deletion of one or more of amino acids 31 to 33 and/or the addition of a N-terminal or C-terminal stabilizing peptide sequence. The analogues are particularly useful for the prophylaxis or treatment of stomach and bowel-related disorders and for ameliorating side effects of chemotherapy. Also disclosed are methods and kits for selecting a patient from populations suited for treatment with GLP-2 analogues.
REFERENCES:
patent: 5789379 (1998-08-01), Drucker et al.
patent: 5834428 (1998-11-01), Drucker
patent: 5912229 (1999-06-01), Thim et al.
patent: 5990077 (1999-11-01), Drucker
patent: 5994500 (1999-11-01), Drucker et al.
patent: 6051557 (2000-04-01), Drucker
patent: 6184201 (2001-02-01), Drucker et al.
patent: 6184208 (2001-02-01), Deigin et al.
patent: 6297214 (2001-10-01), Drucker
patent: 6586399 (2003-07-01), Drucker
patent: 6770620 (2004-08-01), Henriksen
patent: 7049284 (2006-05-01), Drucker
patent: 7411039 (2008-08-01), Thim et al.
patent: 2002/0025933 (2002-02-01), Knudsen et al.
patent: 2003/0040478 (2003-02-01), Drucker et al.
patent: 2003/0109449 (2003-06-01), Drucker et al.
patent: 2003/0158101 (2003-08-01), Drucker
patent: 2003/0162703 (2003-08-01), Drucker et al.
patent: 2003/0207809 (2003-11-01), Drucker
patent: 2004/0052862 (2004-03-01), Henriksen et al.
patent: 2004/0122210 (2004-06-01), Thim et al.
patent: 2004/0127418 (2004-07-01), Knudsen et al.
patent: 2005/0282749 (2005-12-01), Henriksen et al.
patent: 2006/0105954 (2006-05-01), Drucker
patent: WO 96/32414 (1996-10-01), None
patent: WO 97/39031 (1997-10-01), None
patent: WO 99/46283 (1999-09-01), None
patent: WO 01/04156 (2001-01-01), None
patent: WO 01/41779 (2001-06-01), None
patent: WO 02/066511 (2002-08-01), None
U.S. Appl. No. 11/429,168, filed May 4, 2006, Larsen et al.
Benjamin et al., “Glucagon-Like Peptide-2 Enhances Intestinal Epithelial Barrier Function of Both Transcellular and Paracellular Pathways in the Mouse,”Gut47:112-119 (2000).
Booth et al., “Teduglutide ([Gly2]GLP-2) Protects Small Intestinal Stem Cells from Radiation Damage,”Cell Prolif. 37:385-400 (2004).
Boushey et al., “Glucagon-Like Peptide (GLP)-2 Reduces Chemotherapy-Associated Mortality and Enhances Cell Survival in Cells Expressing a Transfected GLP-2 Receptor,”Cancer Res. 61:687-693 (2001).
Cheeseman, “Upregulation of SGLT-1 Transport Activity in Rat Jejunum Induced by GLP-2 Infusion in Vivo,”Am. J. Physiol. 273:R1965-1971 (1997).
DaCambra et al., “Structural Determinants for Activity of Glucagon-Like Peptide 2,”Biochemistry39:8888-8894 (2000).
Drucker et al., “Induction of Intestinal Epithelial Proliferation by Glucagon-Like Peptide 2,”Proc. Nat. Acad. Sci. U.S.A. 93:7911-7916 (1996).
Ferrone and Scolapio, “Teduglutide for the Treatment of Short Bowel Syndrome,”Ann. Pharmacother. 40:1105-1109 (2006).
Guan et al., “GLP-2-Mediated Up-Regulation of Intestinal Blood Flow and Glucose Uptake is Nitric Oxide-Dependent in TPN-Fed Piglets,”Gastroenterology125:136-147 (2003).
Jeppesen, “The Use of Hormonal Growth Factors in the Treatment of Patients with Short-Bowel Syndrome,”Drugs66:581-589 (2006).
Sinclair and Drucker, “Proglucagon-Derived Peptides: Mechanisms of Action and Therapeutic Potential,”Physiology20:357-365 (2005).
Tavares et al., “Ezymatic- and Renal-Dependent Catabolism of the Intestinotropic Hormone Glucagon-Like Peptide-2 in Rats,”Am. J. Physiol. Endocrinol. Metab. 278:E134-E139 (2000).
Thulesen et al., “Glucagon-Like Peptide 2 (GLP-2) Accelerates the Growth of Colonic Neoplasms in Mice,”Gut53:1145-1150 (2004).
Wøjdemann et al., “Inhibition of Sham Feeding-Stimulated Human Gastric Acid Secretion by Glucagon-Like Peptide-2,”J. Clin. Endocrinol. Metab. 84:2513-2517 (1999).
Yusta et al., “Enteroendocrine Localization of GLP-2 Receptor Expression in Humans and Rodents,”Gastroenterology119:744-755 (2000).
Drucker et al., “Regulation of the Biological Activity of Glucagon-like Peptide 2 In Vivo by Dipeptidyl Peptidase IV”Nature Biotechnology15:673-677 (1997).
International Search Report from PCT/GB2006/001633 dated Oct. 24, 2006.
Larsen Bjarne Due
Petersen Yvette Miata
Bieker-Brady Kristina
Clark & Elbing LLP
Dang Ian
Landsman Robert
Zealand Pharma A/S
LandOfFree
Methods of treating chemotherapy-induced diarrhea/mucositis... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods of treating chemotherapy-induced diarrhea/mucositis..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods of treating chemotherapy-induced diarrhea/mucositis... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4165637