Method for inducing sustained immune response

a natural immune system and immune system technology, applied in the direction of immunological disorders, drug compositions, peptide/protein ingredients, etc., can solve the problems of not being totally effective in treating or preventing the development of aids, the use of il2 is normally accompanied by major toxicity, and the patient is more susceptible to pathological infections or malignancies, so as to promote a sustained cell increase in immune system response and increase immune system response , the effect of sustained immune respons

Inactive Publication Date: 2014-01-23
TNI BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patient class is more susceptible to pathological infections or malignancies against which a normal immune system would have otherwise provided sufficient protection.
Unfortunately, the use of IL2 is normally accompanied by major toxicity (Davey, et al., JAMA, 2000; 284: 183-189).
Nevertheless, given the potential promise of these therapies directed toward anti-retroviral effects, none have proven to be totally effective in treating or preventing development of AIDS.
In addition, many of these compounds cause adverse side effects including low platelet count, diarrhea, nausea, renal toxicity, and bone marrow cytopenia (Kempf, et al., U.S. Pat. No. 6,017,928; Lai, et al., U.S. Pat. No. 6,093,743).

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

In Vivo Administration of Met-Enkephalin as a ‘Therapeutic Vaccine’

[0040]An original 12 week double blind study designed to measure the effects of a regular dosing schedule of met-enkephalin on cytotoxic T cells levels in HIV-infected patients was undertaken. Dosages for each patient varied according to group: (1) 60 μg / Kg; (2) 125 μg / Kg and (3) placebo. The patients were administered either active agent (met-enkephalin) or placebo (normal saline; control group) once a week for twelve weeks by means of intravenous infusions. At the eight and twelve week mark, samples from each patient were taken in order to measure levels of T-cells. At twelve weeks the infusions were stopped. Measurement of T-cell counts were again recorded 4 weeks after stopping the infusions (16 week time point). The results show sustained response levels of cytotoxic T cells a month after the last dosing of met-enkephalin.

TABLE IIImmunological Values One Month After Last N-Saline InfusionBASELINEONE MONTHDIFFERE...

example 2

In Vivo Administration of Met-Enkephalin of Advanced AIDS Patients

[0048]Six advanced AIDS patients with CD4 Counts of less than 200 cells per μl were treated with an intermittent therapy of met-enkephalin. During an initial dosage regimen, dosages of met-enkephalin were given at 20 μg / Kg bodyweight of the subject three times per week for 4 weeks. Thereafter, subjects were given 20-100 μg / Kg bodyweight on an as-needed basis. Patients 4 and 6 had intermittent treatments after an initial dosage regimen.

[0049]Results at the start of the regimen, after one month of regular initial dosage regimen, and, for patients 4 and 6, after 3 additional months of intermittent therapy are given in Table IV and V.

TABLE IVAIDS Patients Rx Regimen and Clinical EvaluationMet-EnkPatientRxTreatmentAssociatedClinicalDescriptionPre-Rx statusRegimenDurationTreatmentEvaluation1. 42 Yr. MaleKapos Sarcoma20 μg / Kg, 4 mos.Kaposi Sarcoma stableHomosexual(Cutancous)3x / wkNo opportunistic infectionPheumocystis carinii...

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Abstract

A method for promoting a sustained increased level of T-cell production in immunocompromised subjects in which method enkephalin peptides are administered according to an intermittent dose schedule. In particular, the method involves treatment of immunocompromised patients which includes the administration of enkephalin, either alone or in conjunction with other therapies, in an initial dosage regimen, with periodic booster dosages of enkephalin as necessary to maintain sustained immune system response.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Divisional of U.S. application Ser. No. 10 / 146,999 filed on May 16, 2002, which claims the benefit of priority of U.S. Provisional Application No. 60 / 291,237, filed on May 16, 2001. All of the above applications are hereby expressly incorporated by reference into the present application.FIELD OF THE INVENTION[0002]The present invention relates to methods of stimulating and promoting a sustained natural immune system response, resulting in increased resistance and inhibition of infectious agents, including viruses, bacteria, fungi and parasites, and other immunodeficiency-related ailments. More specifically, the invention relates to an intermittent dose schedule for promoting a sustained increased level of T-cell production (cytotoxic T cells).BACKGROUND OF THE INVENTION[0003]The immune system protects the body against infectious agents, including bacteria, viruses, fungi, and parasites. In addition, the immune system...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/17A61K45/06A61K38/00A61K38/12A61K38/33
CPCA61K38/1709A61K45/06A61K38/33A61K38/00A61P35/00A61P37/00A61P37/04
Inventor PLOTNIKOFF, NICHOLAS P.
Owner TNI BIOTECH INC
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