Use of 17-ketosteroid compounds, as well as derivatives, metabolites and precursors for treatment of hapatitis C type virus and other togavirus infections

A technology of toga virus and metabolites, applied in the direction of steroids, antiviral agents, medical preparations containing active ingredients, etc., can solve problems such as difficult implementation or standardization

Inactive Publication Date: 2001-12-26
HOLLIS EDEN PHARMA
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  • Abstract
  • Description
  • Claims
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Examples

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Embodiment 2

[0403] Example 2. BrEA formulation 2. A formulation containing 100 mg / mL of BrEA (10% w / w) in 30.4% w / w benzyl benzoate (USP), 30.7% w / w polyethylene glycol 300 (NF), approximately 28% w / w propylene glycol (USP) and 1.9% w / w benzyl alcohol (NF), this formulation, hereinafter referred to as "Formulation 2", was prepared as follows. A predetermined amount of BrEA (1.0 kg) was suspended in PEG300 (approximately 3.0 L) present in the dosing container, followed by mixing for at least 5 minutes at room temperature to form a homogeneous emulsion. Thereafter the necessary amount of propylene glycol (about 1.5 L) was added and mixing continued for at least 5 minutes to form a homogeneous suspension. Benzyl benzoate (approximately 3.0 L) was added and the contents of the vessel were mixed for approximately 5 minutes, resulting in a translucent suspension. Benzyl alcohol (about 200ml) was added and mixing continued for about 5 minutes to give a clear colorless solution. Propylene glyco...

Embodiment 3

[0404] Example 3. Human clinical trials. The clinical trial protocol includes approximately 15-20 patients. In Phase I or I / II trials, patients are moderately infected with one or more togaviruses (eg, HCV) and they are moderately symptomatic. Patients received treatment for 1, 2 or 3 weeks. In 3, 4 or 5 days of the patient's medication week, two or more dosage groups, such as 25, 50 or 100 mg / day of 16α-bromo-androsterone ( BrEA) or its esters. Dosing is on consecutive days or on an intermittent schedule, eg 2, 3 or 4 doses administered every other day. The formulation containing BrEA is a formulation as described herein, eg the formulation of example 1 or 2, preferably the formulation of example 2. During the week of treatment and 1, 2, 3, or more weeks thereafter, regular blood draws were drawn to assess infection or its symptoms, pharmacokinetics, blood cytokines (e.g., IL-2, IL-4, IL- 10, IGF1, γIFN, GM-CSF) and intracellular cytokines (eg IL-2, IL-4, IL-10, IGF1, γI...

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Abstract

The present invention provides 17-keto steroid compounds and their derivatives, metabolites and precursors and pharmaceutically acceptable salts thereof for the treatment or prevention of hepatitis C virus and/or hepatitis G virus in patients requiring such treatment, these compounds Collectively referred to as "compounds of the present invention". In addition, the present invention provides methods of treating or preventing togavirus infections including one or more of alphaviruses, flaviviruses (such as yellow fever virus), hepatitis C virus, and hepatitis G virus, Infection with rubella virus or pestiviruses (such as bovine viral diarrhea virus). In addition, the present invention provides combination therapy comprising the administration of one or more compounds described herein and the administration of one or more compounds selected from the group consisting of plasma concentration-enhancing compounds, macrophage stimulating factors, oxidative agents, ribavirin, and alpha interferon compounds and/or oxygen supply. The compounds of the invention may also be used to alleviate or alleviate one or more symptoms associated with togavirus infection.

Description

Background of the invention [0001] The present invention relates to steroidal compositions and methods of using them to treat flavivirus and togavirus infections, such as hepatitis C virus ("HCV") infections. [0002] The present invention relates to 17-keto steroids and derivatives, metabolites and precursors of such compounds and any pharmaceutically acceptable salts thereof (collectively referred to as "compounds of the invention") optionally in combination with one or more other chemical agents and / or methods of treatment (as described below) for the treatment of hepatitis C virus and / or hepatitis G virus in a patient in need of such treatment. Furthermore, the present invention relates to methods of treating togaviruses, including alphaviruses (also known as arboviruses group A), flaviviruses (also known as arboviruses group B) (such as yellow fever , hepatitis C and hepatitis G), rubellaviruses (such as rubella) and pestiviruses (also known as mucosal disease viruses) (...

Claims

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Application Information

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IPC IPC(8): A61K31/353A61K31/357A61K31/56A61K31/5685A61K31/565A61P7/08A61P31/14C07J1/00C07J3/00
CPCA61K31/56A61K31/565A61K31/568A61K31/5685C07J1/0011C07J3/005A61P31/14A61P33/02A61P33/06A61P7/08Y02A50/30A61K2300/00
Inventor 克拉伦斯·纳撒尼尔·阿勒姆詹姆斯·马丁·弗林克帕特里克·T·普伦德加斯特
Owner HOLLIS EDEN PHARMA
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