Pharmaceutical composition for treatment and prevention of chronic disease

a technology of pharmaceutical compositions and compositions, applied in the field of pharmaceutical compositions, to achieve the effect of low efficacy

Inactive Publication Date: 2020-03-26
STELIC INST OF REGENERATIVE MEDICINE STELIC INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011]It is necessary to develop a novel treatment method for chronic disease for whi

Problems solved by technology

However, based on research conducted on knockout mice, although circulating leukocytes invade inflammatory tissue even

Method used

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  • Pharmaceutical composition for treatment and prevention of chronic disease
  • Pharmaceutical composition for treatment and prevention of chronic disease
  • Pharmaceutical composition for treatment and prevention of chronic disease

Examples

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example 1

[0086]The following provides an explanation of a clinical trial of the pharmaceutical composition of the present invention based on Sections 8 and 9 of the phase IIa clinical trial protocol of STNM01. Furthermore, in the following explanation, although terms such as “will be” representing the future tense are used in the description of the trial protocol, the clinical trial was actually completed by the filing date of the present application.

[0087]Clinical Trial Protocol Section 8—Trial Design and Scheduled Sample Size

[0088]8.1 Trial Design

[0089]This clinical trial is a randomized double-blind, placebo-controlled parallel-group trial of STNM01 by single-dose submucosal injection.

[0090]Freeze-dried STNM01 will be diluted using physiological saline. The trial drug will be administered submucosally into the rectosigmoid colon using an endoscope. The patients will be randomized so as to receive STNM01 (a concentrations of 25 nM and 250 nM) or a placebo. The subjects will receive a singl...

example 2

[0197]The present example provides an explanation of the results of a repeated-dose investigator initiated trial (IIT) in which biological preparation (Infliximab and / or Adalimunab)-resistant ulcerative colitis (UC) patients were administered the pharmaceutical composition of the present invention (STNM01).

[0198]FIG. 7 is a schematic diagram of the trial design of the investigator initiated trial of the present example. A total of five subjects observed to be resistant to a biological preparation (Infliximab and / or Adalimunab) in screening were administered 250 nM STNM01 by submucosal injection using an endoscope for a total of three times consisting of baseline (week 0) and in week 2 and week 4. In the trial of Example 1, subjects administered a biological preparation were administered STNM01 following a washout period during which time the biological preparation was not administered for one month. In the trial of Example 2, however, STNM01 was administered while continuing adminis...

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Abstract

An object of the present invention is to develop a novel treatment method for chronic diseases for which conventional treatment methods are either ineffective or for which efficacy is low. The present invention provides a pharmaceutical composition for the treatment and/or prevention of an inflammatory chronic disease that is used in combination with a biological preparation that inhibits leukocyte tissue invasion. The pharmaceutical composition of the present invention contains as an active ingredient thereof siRNA suppressing the expression of CHST15 gene that contains a structure formed by the hybridization of RNA containing the base sequence represented by SEQ ID NO: 1 with RNA complementary thereto.

Description

TECHNICAL FIELD[0001]The present invention relates to a pharmaceutical composition comprising as active ingredients thereof siRNA and a DNA vector capable of expressing that siRNA, and more particularly, relates to inhibition of expression of human CHST15, a pharmaceutical composition comprising as active ingredients thereof siRNA and a DNA vector capable of expressing that siRNA, the use thereof, and an administration method.BACKGROUND ART[0002]Many chronic diseases are autoimmune diseases that are associated with chronic inflammation. In recent years, attention has focused on the invasion of tissue by leukocytes involved in inflammation as a novel treatment target for these chronic diseases. The invasion of inflammatory tissue by leukocytes circulating in the blood consists of the four stages indicated below. Namely, (1) decrease in leukocyte flow rate due to a first interaction between vascular endothelial cells and leukocytes in the vicinity of the inflammation site (rolling), (...

Claims

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Application Information

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IPC IPC(8): A61K31/7105A61K31/713A61K31/711C07K16/28A61K38/13A61P37/06A61P1/00
CPCA61P1/00A61K45/06C07K16/2839A61K31/7105A61P37/06A61K31/711A61K31/713A61K38/13A61P1/18A61P11/06A61P29/00C12N2310/14C12N15/63C12N15/113
Inventor YONEYAMA, HIROYUKI
Owner STELIC INST OF REGENERATIVE MEDICINE STELIC INST
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