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Gonadotropin-releasing hormones for use as adjuvant immunotherapeutics

An immunotherapy, sex hormone technology, applied in the direction of antiviral agents, allergic diseases, organic active ingredients, etc. Effects of long-term prevention of STD progression

Pending Publication Date: 2019-10-25
ISR IMMUNE SYST REGULATION HLDG AB (PUBL)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the long-term efficacy of antiretroviral therapy is affected by patient compliance, drug toxicity, and drug resistance

Method used

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  • Gonadotropin-releasing hormones for use as adjuvant immunotherapeutics
  • Gonadotropin-releasing hormones for use as adjuvant immunotherapeutics
  • Gonadotropin-releasing hormones for use as adjuvant immunotherapeutics

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Example 1: Phase II clinical study of open label

[0077] An open-label, uncontrolled, single-center Phase IIa clinical study was conducted by the Clinical Research Group at the University of Pretoria, South Africa. Research outline such as image 3 shown. Subjects were HIV 1-infected antiretroviral therapy (ART)-naïve male patients (n=26). Inclusion criteria were asymptomatic, confirmed HIV-1 infection documented by HIV antibody test, male, age 18-50 years, CD4 + T cell count >350 cells / μl whole blood, and HLA-A*0205, HLA-A*3002, or HLA-B*1503 haplotype positive. The patient administered buserelin acetate nasal spray solution ( Sanofi-Aventis) 28 days. To compensate for any endocrine side effects, the patient received a further intramuscular injection of 150 mg testosterone cypionate ( - Testosterone, Pfizer). The primary study objective was to assess the safety and tolerability of intranasal buserelin acetate for 28 days, and the secondary study objectives w...

Embodiment 2

[0082] Example 2: Follow-up Study and Interim Analysis

[0083] To investigate the long-term effects of GnRH therapy in patients with HIV / AIDS, in particular to develop ways to minimize the risk of disease progression, a follow-up study and an interim analysis were performed 36-48 months after the open-label phase II clinical study . The aim of the study was to assess the progression of HIV infection over the time period from completion of the phase IIa clinical study (Example 1 ) based on assessment of past and present clinical, immunological and virological status.

[0084] Follow-up included 13 of the initial 26 patients, nine of whom underwent a full clinical examination. For interim analyses, disease progression was based on immunologic criteria and was defined as a medical condition in which a patient developed any AIDS-defining disease (eg, tuberculosis infection) during the period from the last day of treatment in the clinical trial to the day of follow-up, or CD4 me...

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Abstract

The present invention relates to the use of a gonadotropin-releasing hormone (including GnRH I, a GnRH I analogue, GnRH II, or a GnRH II analogue) as adjuvant immunotherapeutic.

Description

technical field [0001] The present invention relates to the use of gonadotropin-releasing hormone (including GnRH I, GnRH I analogs, GnRH II or GnRH II analogs) as an adjuvant immunotherapeutic agent. The use of GnRH and its analogues minimizes the risk of progression of viral diseases, especially HIV. The present invention also relates to pharmaceutical compositions or pharmaceutical kits comprising gonadotropin-releasing hormone for use as an adjuvant immunotherapeutic agent, and methods of treating human or animal subjects comprising administering gonadotropin-releasing hormone to induce Progression risk is minimized. Background technique [0002] CD4 + Cells are key mediators of the immune response and are major targets of HIV infection and related viral diseases. The current standard of care for HIV patients is antiretroviral therapy (ART), which combines various antiretroviral (ARV) drugs that work synergistically to suppress HIV and mitigate disease progression. H...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/09A61K31/568A61K31/4178A61P37/04A61P31/12A61P31/18
CPCA61K38/09A61K31/568A61K31/4178A61P31/12A61P31/18A61P37/04A61K2300/00A61K31/05A61K31/565A61K31/566A61K31/567A61K31/5685A61K31/57A61K31/58
Inventor 欧拉·温克韦斯特延·隆德格伦
Owner ISR IMMUNE SYST REGULATION HLDG AB (PUBL)
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