Activation of the endogenous ileal brake hormone pathway for organ regeneration and related compositions, methods of treatment, diagnostics, and regulatory systems

A composition, organ technology, applied in the fields of regenerating hepatocytes, pancreatic beta cells of subjects, reducing cellular inflammation and regenerating nerve cells

Inactive Publication Date: 2017-05-17
杰罗米申塔格 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As expected, weight savings with RYGB over Brake TM Faster because RYGB surgery also physically reduces the size of the stomach, limiting intake in a second profound way relative to the ileal brake approach alone

Method used

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  • Activation of the endogenous ileal brake hormone pathway for organ regeneration and related compositions, methods of treatment, diagnostics, and regulatory systems
  • Activation of the endogenous ileal brake hormone pathway for organ regeneration and related compositions, methods of treatment, diagnostics, and regulatory systems
  • Activation of the endogenous ileal brake hormone pathway for organ regeneration and related compositions, methods of treatment, diagnostics, and regulatory systems

Examples

Experimental program
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Effect test

Embodiment 1

[0403] Example 1: Formulations for Pancreas Regeneration to Improve T2D

[0404] The subject invention for the treatment of T2D relates to a pharmaceutical formulation or dosage form comprising a first active drug comprising an ileal brake hormone releasing substance, which is coated with an immediate or delayed release layer of a second active drug, said second active drug The medicament preferably comprises the antihyperglycemic drug metformin or a pharmaceutically acceptable salt thereof, or sitagliptin or a substitute from the list of available DPP-IV inhibitors as defined herein. The ileal brake hormone releasing substance is delivered in a controlled release manner from a tablet core, preferably an osmotic tablet core without gelling or swelling polymers.

[0405] The composition of the tablet core should include an ileal brake hormone releasing substance and at least one pharmaceutically acceptable excipient. In one embodiment of the invention, the tablet core comprise...

Embodiment 2

[0461] Example 2: Using MetaBrake TM pancreatic beta cell regeneration

[0462] Metformin is the main treatment for T2D worldwide, and all biguanides show dose-related reductions in hyperglycemia. Several studies of metformin in T2D patients have shown a reduction in the cardiovascular risk profile. This can be achieved by lowering glucose, or it can be the result of moderate weight loss, or both. Metformin alone is known not to regenerate pancreas or liver in patients with T2D, nor does it directly affect the cardiovascular system or vascular endothelium. When we examined our control patients treated with metformin, we confirmed that even at a dose of 2.0 grams per day, there were no significant changes in any parameters indicative of regeneration. Specifically, the FS index increased with metformin alone and it slowly lost control of T2D in all parameters. see Figure 4 , Figure 5 , Figure 18 and Figure 19 , to account for the rise in the FS index and the loss of ...

Embodiment 3

[0496] Example 3. Obesity and connection with gut microbiota

[0497] Use of the disclosed treatments and methods of modifying the human gastrointestinal flora for the purpose of triggering regeneration of pancreatic beta cells, liver cells and regeneration of gastrointestinal cells to facilitate treatment of metabolic syndrome based on the discovery. The probiotics selected for the coating in the formulation of the second active ingredient were Faecalibacterium prausnitzii, Bacteroides thetaiotaomicron, and Lactobacillus johnsonii. The approximate dose of these strains released in the ileum according to the formulation was 10^6 to 10^8 colony forming units. It is expected that these specific organisms will be co-formulated with typical probiotic bacterial organisms such as lactobacilli and bifidobacteria.

[0498] including Brake TM Clinical evidence of the utility of these synergistic combinations of diabetes therapies with probiotic replacement organisms will be provided...

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Abstract

In one embodiment, the invention provides a method of regenerating organs and tissues in a subject suffering from one or more organ or tissue manifestations of glucose supply side associated metabolic syndrome, the method comprising: (a) confirming that the subject suffers from or is at risk for suffering from organ and / or tissue damage associated with a glucose supply side associated metabolic syndrome; and (b) co-administering to the subject an effective amount of a pharmaceutical composition comprising a first and optionally a second active composition, said first active composition comprising an ileal brake hormone releasing substance encapsulated within an enteric coating which releases said substance within said subject's ileum and ascending colon causing release of at least one ileal brake hormone from L-cells of said subject, said optional second active composition being formulated in immediate and / or early release form in an over coating onto said enteric coating, wherein said second composition is beneficial to at least one aspect of said subject's metabolic syndrome manifestations. Coadministration methods with a second pharmaceutical composition are also disclosed.

Description

[0001] field of invention [0002] The inventors herein disclose new pathways and system controllers for organ and tissue regeneration, as well as pharmaceutical compositions for regulating and controlling the process. Accordingly, the present invention provides pharmaceutical compositions, methods of treatment, diagnostics and computer-implementable systems related to the regeneration of organs damaged by various metabolic syndromes, including hyperlipidemia, insulin resistance, hyperlipidemia, Blood pressure, atherosclerosis, fatty liver disease, and certain chronic inflammatory states, among others. [0003] In one embodiment, the present invention provides a method of regenerating pancreatic beta cells in a subject with type 2 diabetes (T2D). The method comprises administering to a subject in need thereof a pharmaceutical dosage form comprising an effective amount of an ileal brake hormone releasing substance comprising at least one enteric-coated or delayed-release microbe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7004A61K38/55A61P3/10G16H20/10G16H50/30
CPCA61K45/06A61K31/138A61K31/401A61K35/741A61K9/209G16H50/30A61K31/155A61K31/555A61K31/7004A61P1/00A61P1/04A61P1/16A61P1/18A61P11/00A61P13/12A61P19/02A61P25/00A61P25/28A61P29/00A61P3/04A61P3/06A61P43/00A61P9/00A61P9/04A61P9/10A61P9/12A61P3/10G16H20/10Y02A90/10A61K2300/00A61K36/05A61K36/48A61K36/8998
Inventor 杰罗米.申塔格约瑟夫.M.费亚德
Owner 杰罗米申塔格
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