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Combination therapy with glatiramer acetate and riluzole

A technology of glatiramer acetate and a composition, which is applied in the field of combined therapy using glatiramer acetate and riluzole, can solve the problems of difficult to predict when the effect will occur, what changes will occur, become obvious and the like.

Inactive Publication Date: 2008-07-23
TEVA PHARMA IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, when two drugs are administered to treat a disease, it is not possible to predict what changes will occur in each drug's negative side profile
[0020] Also, it is really difficult to predict when the effects of an interaction between two drugs will become apparent

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0187] Example 1: Glutamate Toxicity

[0188] Under normal conditions, glutamate acts as an essential neurotransmitter. However, when glutamate levels rise above normal levels, glutamate becomes toxic. Elevated glutamate levels and resulting toxicity are involved in a number of diseases, as discussed in the Background of the Invention.

[0189] method

[0190] Sixty mice were injected with glutamate (0.2M) to induce retinal ganglion cell (RGC) death. As indicated in Table 1, mice were immunized with glatiramer acetate, riluzole, or both prior to glutamate injection. Glatiramer acetate was administered s.c. (subcutaneously), 100 [mu]l / mouse, with or without adjuvant. Glatiramer acetate can also be administered orally, with or without adjuvants. Glatiramer acetate can be administered in more than several doses prior to the glutamate challenge, or can be administered concurrently with glutamate. Riluzole was administered by gavage in 4 doses of 10 mg / kg each. Control ani...

Embodiment 2

[0196] Example 2: MPTP-induced dopaminergic neurotoxicity

[0197] MPTP is a neurotoxin that damages nigrostriatal dopaminergic neurons in some mammalian species, including mice, and produces parkinsonism in humans and primates. A key initial step in its neurotoxic mechanism involves the conversion of MPTP to its toxic metabolite 1-methyl-4-phenylpyridinium ion (MPP+). This reaction is catalyzed by the enzyme MAO-B and likely occurs outside dopaminergic neurons, primarily in glia (US Patent No. 6,316,504).

[0198] method

[0199] i) animal

[0200] Mice (C57B16 males, weighing 20-25 g, 6-8 weeks old) were obtained from Harlan (Jerusalem) and housed 5 per cage for 1 week prior to treatment. Standard rat chow and water were provided ad libitum. Room lighting was 12 hours light, 12 hours dark; lights started at 7:00AM. The cages were placed in a locked room in the animal house, accessible only to personnel familiar with the safety guidelines for MPTP administration and ...

Embodiment 3

[0225] Example 3: Experimental Model for Amyotrophic Lateral Sclerosis

[0226] method

[0227] Transgenic mice carrying multiple copies of the human G93A Cu / Zn SOD mutation are considered the best model system for anterior horn cell degenerations, such as amyotrophic lateral sclerosis (Ludolph et al; Gurney et al 1994 and 1996).

[0228] i) animal

[0229] Transgenic mice overexpressing the human Cu / Zn-SOD G93A mutation ((B6SJL-TgN(SOD1-G93A)1Gur) and non-transgenic B6 / SJL mice were purchased from Jackson Laboratory (Bar Harbor, ME, USA). G1H The second generation of mice.

[0230] ii) treatment solutions

[0231] In 5 groups (N=15), SOD1 transgenic mice were treated with two doses of glatiramer acetate alone or in combination with riluzole. Groups of 15 mice served as controls.

[0232] The treatment plan for the 6 groups is as follows:

[0233] Group I: low dose glatiramer acetate

[0234] Group II: high dose glatiramer acetate

[0235] Group III: Riluzole 30m...

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Abstract

The present invention provides a method for providing neuroprotection to the central or peripheral nervous system of a subject in need of such neuroprotection, which comprises periodically administering to the subject a certain amount of glatiramer acetate and a certain amount of 2-amino-6 - Trifluoromethoxybenzothiazole, wherein said amount is effective to provide neuroprotection to said subject's central or peripheral nervous system when taken together. The present invention also provides a package comprising glatiramer acetate, 2-amino-6-trifluoromethoxybenzothiazole, and a composition for use together to provide neuroprotection to the central or peripheral nervous system of a subject in need of such neuroprotection. Neuroprotective Instructions for Use. Furthermore, the present invention provides a pharmaceutical composition comprising an amount of glatiramer acetate and an amount of 2-amino-6-trifluoromethoxybenzothiazole, wherein said amounts are effective to provide for Neuroprotection of the subject's central or peripheral nervous system. The present invention also provides a pharmaceutical combination comprising a certain amount of glatiramer acetate and a certain amount of 2-amino-6-trifluoromethoxybenzothiazole in separate dosage forms, the combination is effective for providing Neuroprotection of the central or peripheral nervous system. Additionally, the combination therapy may be used to treat a subject afflicted with multiple sclerosis or a subject afflicted with amyotrophic lateral sclerosis.

Description

[0001] Throughout this application, various publications are cited in parentheses. Full citations of these publications can be found at the end of the specification, listed in alphabetical order immediately preceding the claims. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the prior art to which this invention pertains. field of invention [0002] The present invention relates to combination therapy with glatiramer acetate and riluzole for neuroprotection, multiple sclerosis and amyotrophic lateral sclerosis. Background of the invention [0003] Neuroprotection refers to the protection of the central or peripheral nervous system from neuronal loss, axonal loss and / or myelin loss. Neuroprotection is postulated to be one way to achieve treatment of neurodegenerative diseases and neurotrauma. [0004] One of the more common neurological disorders in adults is multiple scler...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/00A61K31/425
Inventor L·哈亚尔德尼E·克林格尔E·布拉屋格朗德
Owner TEVA PHARMA IND LTD
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