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Hsp therapy in conjunction with a low antigenicity diet

a low-antigenicity, hydrolyzed protein technology, applied in animal/human proteins, metabolism disorders, non-active ingredients of pharmaceuticals, etc., can solve the problems of difficult to distinguish clinically between type 1 and type 2 diabetes, increase the risk of type 1 diabetes in finnish children, and the immune destruction process is much slower. , to achieve the effect of improving the protective effect of hydrolyzed protein/low-antigenic di

Inactive Publication Date: 2007-03-15
ANDROMEDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0023] The present invention provides a method for improvement of the protective effect of a hydro

Problems solved by technology

1993, Diabetes 42 1786-1790) that early introduction of dairy products is associated with increased risk of type 1 diabetes in Finnish children.
However, a review of the evidence supporting this theory does not indicate that BSA was ever tested for diabetogenic activity in the absence of β-casein.
The immune destructive process is much slower, making it sometimes difficult to distinguish clinically between type 1 and type 2 diabetes.
It is still unclear whether early treatment with insulin is beneficial for the remaining beta cells.
However, there is no evidence presented of any trials where either human or animal subjects were fed milk or milk products with denatured BSA.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Neonatal Oral Administration of DiaPep277 in Combination with the Protective Hydrolyzed Casein Diet

Materials and Methods:

[0090] Experimental Set-Up:

[0091] Group-housed BB-DP rats (breeding colony, Groningen, the Netherlands) were orally inoculated once per day with either placebo (aqua dist.) or Diapep277 at days 4, 5, 6 and 7 of life (black box in FIG. 1). Animals were treated in compliance with the principles of laboratory care (NIH publication no. 85-23, revised 1985) and the Dutch law on experimental animal care. Inoculation was done via a silicon-tube swallowed by the neonate and fluid was inoculated directly into the stomach. DiaPep277 was supplied by Peptor Ltd., Rehovot, Israel. It is an analog of the native 437-460 sequence of human hsp60, in which the existing cystein residues at positions 442 and 447 were replaced by valine, for better chemical stabilization. Per inoculation 300 μg / rat of Diapep277 in a volume of 300 μl was administered. At the age of 21 days (gray bo...

example 2

Dose Response Effect of Oral Administration of DiaPep277 on the Development of Diabetes Type 1 in the BB-DP Rat

[0097] It was shown that neonatal oral administration of DiaPep277 in combination with the protective HC diet significantly delayed the onset of diabetes type 1 in the BB-DP rat and decreased the incidence by 64% compared to placebo controls on a conventional diet. Administration of DiaPep277 in combination with a conventional diet tended to lower the incidence. Instead of 85% only 69% of the animals became diabetic. In this previous experiment orally DiaPep277 was administered on four consecutive days (day 4, 5, 6, and 7 of life) in a concentration of 300 μg / rat / day. Since this dose by itself tended to lower the diabetes incidence a dose response experiments are performed to check whether the effect of DiaPep277 becomes more pronounced at higher doses and whether a prolongation of the administration period (longer than four consecutive days) also increases the effect of D...

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Abstract

The present invention fragments and analogs of heat shock proteins in combination with a low antigenicity diet for suppression, prevention and treatment of diabetes. The invention is exemplified using DiaPep277™, an analog of residues 437-460 of human Hsp60 in combination with a hydrolyzed casein diet. The invention further relates to orally active pharmaceutical compositions comprising Hsp60 fragments and analogs, such as DiaPep277, useful for suppression, prevention or treatment of diabetes and to a regimen for delaying the onset of type 1 diabetes and for inhibition of insulitis.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of International application PCT / IL2005 / 000100 filed Jan. 27, 2005, which claims the benefit of provisional application 60 / 539,330 filed Jan. 28, 2004. The entire content of each prior application is expressly incorporated herein by reference thereto.FIELD OF THE INVENTION [0002] The invention relates to methods for delaying the onset of autoimmune diseases, particularly Type 1 diabetes, using administration of a fragment of heat shock protein (HSP), particularly DiaPep277 derived from Hsp60, in conjunction with a low antigenicity diet, particularly a diet comprising hydrolyzed casein, and to methods useful for prevention, delay, suppression or treatment of autoimmune diseases using oral administration of DiaPep277. The present invention further relates to formulations adapted for oral administration of DiaPep277 and other hsp60 peptide analogs and fragments. BACKGROUND OF THE INVENTION [0003] Type 1 d...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K38/08
CPCA61K38/018A61K38/164A61K38/1709A61K2300/00A61P3/10
Inventor ROZING, JOHANNESELIAS, DANA
Owner ANDROMEDA BIOTECH
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