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Composition for treatment of and method of monitoring hepatitis C virus using interferon-tau

a technology of interferon and hepatitis c virus, which is applied in the direction of antivirals, drug compositions, peptide/protein ingredients, etc., can solve the problems of difficult in vitro culture of virus, difficult to tolerate ribavirin in combination with ifn-,

Inactive Publication Date: 2005-11-03
PEPGEN CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The invention is a composition for treating HCV in a patient by oral delivery. The composition includes ovine Interferon-tau (OvIFN-τ) in a dosage effective to stimulate levels of 2′,5′-oligoadenylate synthetase (OAS) observed in the bloodstream 24 hours after administration. The composition can also include an oral-delivery vehicle containing OvIFN-τ and effective to release the OvIFN-τ in active form in the stomach. The dosage of OvIFN-τ can be greater than 1×109 Units / day. The composition provides a preferred dose of OvIFN-τ between 108-1010 units. The composition is effective in treating hepatitis caused by HCV and can also include a method of monitoring treatment by measuring the blood levels of OAS."

Problems solved by technology

Although HCV has been cloned, the virus has been difficult to culture in vitro (Trepo, 2000).
Even the beneficial effects of ribavirin, however, are transient (Clarke, 2000; Koskinas, et al., 1995), and because of severe side effects, ribavirin, in combination with IFN-α, can be difficult to tolerate (Cotler, et al., 2000).

Method used

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  • Composition for treatment of and method of monitoring hepatitis C virus using interferon-tau
  • Composition for treatment of and method of monitoring hepatitis C virus using interferon-tau
  • Composition for treatment of and method of monitoring hepatitis C virus using interferon-tau

Examples

Experimental program
Comparison scheme
Effect test

example 1

Induction of OAS with Orally and Intraperitoneally Administered Ovine IFN-τ to Mice

[0131] OvIFN-τ (4.99×108 units / mg protein; Pepgen Corp., California or Biological Process Development Facility, Dept. of Food Science and Technology, University of NE-Lincoln, Lincoln, Nebr.; SEQ ID NO:4) was dissolved in 10% maltose solution to prepare ovIFN-τ Solution. The use of OvIFN-τ (SEQ ID NO:2) is also contemplated in the present invention. Two hundred microliters of ovIFN-τ solution was orally administered to ICR mice (average body weight approximately 30 g, 6 weeks of age, female) using a 20 gauge disposable oral sound (Fuchigami, Kyoto) to inject directly to an upper part of the stomach (gastric administration; GA).

[0132] For intraperitoneal administration (I.P.), 100 microliters of ovIFN-τ solution was used. Sample injection to an upper part of a stomach was confirmed by administration of a dye. Twenty-four hours after the administration, the mouse was anesthetized with Nembutal. Blood ...

example 2

Dose-Dependent Induction of OAS by Oral Administration of IFN-τ in Mice

[0134] Using the same procedure as Example 1, OvIFN-τ was orally administered in units of 0, 103, 104, or 105 to an ICR mouse. Twelve hours after oral administration, whole blood was taken from a mouse heart and an OAS activity of whole blood was determined. As shown in FIG. 2, the OAS activity in whole blood increased in a dose dependent manner.

example 3

Reduced ALT, Reduced HCV Viral Titer, and Induction of OAS by Oral Administration of IFN-τ in Human Patients

[0135] A. IFN-τ Preparation

[0136] On day one, one bottle of Ov-IFN-τ (SEQ ID NO:4) is removed from the refrigerator and the patient self-administers the proper volume of test material according to Table 2. Ov-IFN-τ (SEQ ID NO:2) may also be prepared and administered in the same manner.

TABLE 2Recombinant Ov-IFN-τ Patient Dose AdministrationNumber ofOv-IFN-τVolume (ml)Total DailyDose GroupPatients(mg / ml)per Dose (TID)Dose (ml)I61.00.331.0II61.01.03.0III61.03.09.0IV61.05.015.0

[0137] B. Patient Dosing Instructions

[0138] The patient keeps all vials of test material and syringes in the refrigerator maintained at 2 to 8 degrees centrigrade. Prior to the self-administration of medication, the patient removes one vial and one syringe from the refrigerator. The patient removes the cap from the tip of the syringe, places the tip of the syringe into the bottle of medication and withd...

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Abstract

A method of monitoring treatment of HCV by oral administration of ovine IFN-τ is disclosed. The method includes measuring the blood levels of 2′,5′-oligoadenylate synthetase prior to and after such oral administration, and if necessary, adjusting the dose of IFN-τ until a measurable increase in blood 2′,5′-oligoadenylate synthetase level, relative to the level observed prior to administration, is observed. Also disclosed are oral-delivery compositions for use in treating HCV in an HCV-infected patient comprising ovine IFN-τ, in a dosage effective to stimulate bloodstream levels of 2′,5′-oligoadenylate synthetase.

Description

[0001] This application is a continuation of U.S. application Ser. No. 09 / 910,406 filed Jul. 19, 2001, now pending, which claims the benefit of U.S. Provisional Application No. 60 / 219,128 filed Jul. 19, 2000 and JP 317160 filed Oct. 17, 2000, all of which are hereby incorporated by reference in their entirety.FIELD OF THE INVENTION [0002] The present invention relates to the composition for treatment of conditions relating to hepatitis caused by hepatitis C virus (HCV) infection using Interferon-τ (IFN-τ). The present invention also relates to a method of monitoring treatment of HCV by measuring the blood levels of 2′,5′-oligoadenylate synthetase. REFERENCES [0003] Ausubel, F. M., et al., in CURRENT PROTOCOLS IN MOLECULAR BIOLOGY, John Wiley & Sons, Inc., Media, Pa. (1988). [0004] Balzarini, J, et al., Biochem. Biophys. Res. Commun. 178:563-569 (1991). [0005] Bartol, F. F., et al., Biol. Reprod. 33:745-759 (1985). [0006] Bayne, M. L. et al., Gene 66:235-244 (1988). [0007] Bazer, F. ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/21
CPCA61K38/21A61P1/16A61P31/14
Inventor SOKAWA, YOSHIHIROLIU, CHIH-PING
Owner PEPGEN CORP
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