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Last Updated: April 24, 2024

Claims for Patent: 8,007,790

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Summary for Patent: 8,007,790

Title:	Methods for treating polycystic kidney disease (PKD) or other cyst forming diseases
Abstract:	The present invention is directed to methods of treating or ameliorating an effect of a polycystic disease. More particularly, the methods include administering to a patient in need thereof an amount of a modulator of a tumor necrosis factor (TNF) pathway, which is sufficient to treat or ameliorate an effect of a polycystic disease. Methods of treating or ameliorating an effect of a polycystic kidney disease (PKD) are also provided. Methods are also provided for identifying a candidate compound that may be effective to treat or ameliorate an effect of a polycystic disease or to increase polycystin-2 (PC2) function or decrease Rab11-Family of Interacting Protein2 (FIP2) function. Further provided are methods for identifying a patient having, or who is at risk for developing, a polycystic disease or who would benefit from treatment with a TNF-alpha inhibitor.
Inventor(s):	Li; Rong (Kansas City, MO), Li; Xiaogang (Prairie Village, KS)
Assignee:	Stowers Institute for Medical Research (Kansas City, MO)
Application Number:	11/906,600
Patent Claims:	1. A method of inhibiting or ameliorating renal cyst development in a subject with a polycystic kidney disease comprising administering to a subject in need thereof a therapeutically effective amount of a TNF-.alpha. inhibitor. 2. The method according to claim 1, wherein the polycystic kidney disease is autosomal dominant polycystic kidney disease (ADPKD) or autosomal recessive polycystic kidney disease (ARPKD). 3. The method according to claim 1, wherein the TNF-alpha inhibitor is an antibody or soluble TNF receptor fusion polypeptide that binds TNF-alpha. 4. The method according to claim 3, wherein the TNF-alpha inhibitor is selected from the group consisting of CytoFab (a polyclonal ovine anti TNF-alpha antibody Fab fragment), certolizumab pegol (a PEGylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody), adalimumab (a recombinant human IgG.sub.1 monoclonal anti TNF-alpha antibody), etanercept (a dimeric fusion protein consisting of the extracellular ligand-binding domain of the human 75 kd (p75) TNF receptor linked to the Fc portion of human IgG.sub.1), infliximab (a human-mouse chimeric IgG.sub.1.kappa. anti-TNF-alpha monoclonal antibody), onercept (a recombinant human soluble p55 TNF binding protein), VT-346 (a 43-kd secreted glycoprotein that is a human TNF-alpha inhibitor), golimumab (a fully human anti-TNF-alpha antibody), CYT-6091 (a nanotherapeutic in which TNF-alpha is covalently linked onto the surface of 30 nm particles of pegylated colloidal gold), Dom-0200 (an anti-TNF-alpha human domain antibody), ABX/0401 (a sc humanized anti-TNF-alpha monoclonal antibody), XPro-1595 (a dominant negative protein variant of TNF-alpha that selectively inhibits soluble TNF-alpha), anti-TNF-alpha, ABX/0402 (a humanized anti-TNF-alpha monoclonal antibody), TNF-alpha kinoid (a kinoid vaccine, which induces synthesis of polyclonal antibodies against TNF-alpha), CYT007-TNFQb (a vaccine designed to elicit anti-TNF-alpha antibodies), ESBA-105 (a fully humanized fragment of the VH/VL domains that inhibits TNF-alpha), Dom-0100 (an anti-TNFR1 human domain antibody), PN-0615 (an anti-TNF-alpha human monoclonal antibody), and combinations thereof. 5. The method according to claim 4, wherein the TNF-alpha inhibitor is etanercept. 6. The method according to claim 1, wherein the TNF-alpha inhibitor regulates the activity of tissue necrosis factor (TNF)-alpha. 7. A method of inhibiting or ameliorating renal cyst development in a subject with a polycystic kidney disease (PKD) comprising administering to a subject in need thereof an amount of a TNF-alpha inhibitor comprising etanercept that is sufficient to inhibit or ameliorate an effect of PKD.

Details for Patent 8,007,790

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998	⤷ Try a Trial	2026-04-03
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998	⤷ Try a Trial	2026-04-03
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999	⤷ Try a Trial	2026-04-03
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004	⤷ Try a Trial	2026-04-03
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007	⤷ Try a Trial	2026-04-03
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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