Treatment of multiple sclerosis using interferon-tau

A technology for multiple sclerosis and interferon, applied in allergic diseases, non-central analgesics, medical preparations containing active ingredients, etc., can solve problems such as damage

Inactive Publication Date: 2009-02-11
PEPGEN CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The oral route of administration may be more problematic because of gastric proteolysis, and the molecule may be destroyed in the acidic conditions of the stomach before it reaches its intended target

Method used

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  • Treatment of multiple sclerosis using interferon-tau
  • Treatment of multiple sclerosis using interferon-tau
  • Treatment of multiple sclerosis using interferon-tau

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0188] A , Preparation of IFNτ

[0189] In one embodiment, a synthetic IFNr gene is obtained by ligating oligonucleotides containing a region adjacent to the DNA sequence encoding the IFNr amino acid sequence using standard molecular methods (Ausubel, et al., supra, 1988). The DNA sequence used may be SEQ ID NO: 1 or SEQ ID NO: 4 or the sequence shown in Imakawa, K. et al., Nature, 330: 377-379, (1987). The obtained IFNr polynucleotide coding sequence can span from position 16 to position 531: a coding sequence of 172 amino acids.

[0190] In one embodiment, the full-length synthetic Stul / SStl gene fragment (540bp) can be cloned into the improved pIN III omp-A expression vector and transformed into competent Escherichia coli SB221 strain. To express IFNτ protein, cells carrying the expression vector were grown in L-broth containing ampicillin to an OD(550nm) of 0.5-1 and induced with IPTG (isopropyl-1-thio-b-D-galactoside) 3 hours and then collected by centrifugation. Sol...

Embodiment 1

[0196] Administration of IFNτ to patients with multiple sclerosis

[0197] A. Variable dose studies

[0198] Patients with multiple sclerosis were used in the trial of treatment with IFN[tau]. 15 patients were randomly divided into 3 treatment groups: patients in group I took 0.2 mg orally (2×10 7 unit / day) dose of IFNτ; patients in group II took orally 0.8mg (8×10 7 unit / day) dose of IFNτ; patients in group III took orally 1.8mg (1.8×10 8 units / day) dose of IFNτ.

[0199] Before treatment with IFNT, on the day of screening and on day 1 (1), blood samples were drawn from each subject to determine baseline cytokine concentrations in serum. After blood collection on day 1, each subject started treatment with oral IFNτ. The vials and syringes containing IFNr (SEQ ID NO: 3) were stored in a refrigerator at 2-8°C prior to administration. Before self-administration, the patient takes a vial and a syringe from the refrigerator. On day 1 of the clinic, remove the cap from the t...

Embodiment 2

[0211] Human patients infected with HCV take IFNτ 3 times a day

[0212] A. Preparation of IFNτ

[0213] On the first day, a bottle of IFNτ (SEQ ID NO: 3) was taken out from the refrigerator, and the patient took an appropriate volume of the test material according to Table 3 by himself. IFNr (SEQ ID NO: 2) can also be prepared and administered in the same manner.

[0214] table 3

[0215] Dosage of patients taking recombinant Ov-IFNτ

[0216] Dose group

patient

quantity IFNτ

(mg / mL) Unit Dose (TID)

Volume (mL) total daily dose

(mg) total daily dose

(U) I 6 1.0 0.33 1.0 1×10 8 II 6 1.0 1.0 3.0 3×10 8 III 6 1.0 3.0 9.0 9×10 8

[0217] B. Instructions for patient dosing

[0218] All vials and syringes containing test material were stored in a refrigerator at 2-8°C. Before self-administration, the patient takes a vial and a syringe from the refrigerator. On the first day of the clinic, remove the cap o...

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Abstract

Methods of treating an autoimmune condition by administering IFNtau are described. IFNtau is administered orally at a dose sufficient to obtain a desired clinical endpoint, such as a reduction in new contrast-enhanced brain lesions in multiple sclerosis patients.

Description

technical field [0001] The present invention relates to pharmaceutical compositions containing interferon-τ and methods of use thereof. More specifically, the present invention relates to methods of treating diseases requiring modulation of specific cytokine levels, such as autoimmune diseases, when sufficient doses of interferon tau (IFNT) are administered to obtain the desired clinical effect. Background technique [0002] Interferon tau (hereinafter referred to as "IFNT" or "interferon tau") was originally discovered as a pregnancy recognition hormone produced by the trophectoderm of the ruminant conceptus (Imakawa, K. et al, Nature, 330: 377- 379, (1987); Bazer, F.W. and Johnson, H.M., Am. J. Repro. Immunol., 26:19-22, (1991)). The distribution of the IFNT gene is restricted to ruminants, including cattle, sheep and goats, (Alexenko, A.P. et al., J. Interferon and Cytokine Res., 19:1335-1341, (1999)), but it is found in other species including humans and mouse cells al...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61P37/00
CPCA61K38/21A61P17/06A61P19/02A61P21/04A61P25/00A61P29/00A61P31/12A61P35/00A61P35/02A61P37/00A61P37/02A61P43/00A61P5/14A61P3/10
Inventor 刘治平L·H·维拉里特
Owner PEPGEN CORP
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