Methods of treating amyotrophic lateral sclerosis and neuropathy

A neuropathic, purpose-built technology applied in the field of treatment of amyotrophic lateral sclerosis, capable of solving problems such as prolongation of time

Pending Publication Date: 2020-11-24
MEDDAY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This also prolongs the time before the individual needs ventilatory support

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] Example 1 - Treatment of ALS

[0104] Patients with ALS have been treated with high doses of biotin (100 mg three times a day) and show some stabilization of their disability.

[0105] The 47-year-old man, who began showing symptoms of ALS in February 2013, had difficulty with speech -- speech that was slow and slurred. Speech difficulties worsened over several months, and then the patient began to exhibit lower extremity weakness in summer 2013, as well as some low back pain, occasionally extending to the legs. EMG studies disclose diffuse neurogenic changes with fibrillation potential. Record fasciculations. Biopsy of the right quadriceps (November 2013) was reported as "neurogenic atrophy". CK (creatine kinase) increased intermittently around 350-500 times. Other external tests were negative: Lyme serology, HIV antibodies (abs), ENA, AChR abs, MuSK abs, GM1 abs, genetic testing from dystrophic myotonia type 2: negative. Asialoganglioside GM1: only above the up...

Embodiment 2

[0109] Example 2: Animal Studies of ALS

[0110] The transgenic SOD1(G93A) mouse is the model of choice for the following exploratory studies:

[0111] - Mice develop a disease similar to ALS (weight loss, progressive paralysis).

[0112] - Disease started earlier (110 days vs. 8.5 / 9 months) and progressed faster (death in 5.5 months vs. 14 months) than in other SOD models.

[0113] - The cohorts were very homogeneous in terms of disease progression.

[0114] Proposed proof-of-concept experiment:

[0115] The effect of biotin was evaluated in SOD1(G93A) mice with regard to the clinical efficacy of improved muscle strength and weight gain.

[0116] "Clinical" assessment:

[0117] - 10 transgenic SOD (G93A) mice

[0118] - 2 groups of 5 mice: untreated and biotin-treated (custom diet)

[0119] - The dose used is about 30 mg / kg / day, which is equivalent to the human dose of 5 to 10 mg / kg / day

[0120] -Biotin will be mixed in dry food

[0121] - "Clinical" examinations: f...

Embodiment 3

[0130] Example 3: Use of Biotin to Treat Chronic Inflammatory Demyelinating Polyneuropathy

[0131] Clinical trials can be established to determine the efficacy and safety of high dose biotin on motor and sensory transmission in patients with demyelinating polyneuropathy in patients with:

[0132] - Chronic inflammatory demyelinating polyneuropathy on clinical and neurophysiological basis

[0133] -Proven genetic diagnosis of Xia-Ma-Tu Sanshi 1A

[0134] - Anti-myelin-associated glycoprotein polyneuropathy.

[0135] Inclusion parameters included deterioration of electrophysiological parameters over the past 3 years.

[0136] The primary endpoint was the change from baseline to week 48 in at least two of the four criteria for demyelination:

[0137] · Motor nerve conduction velocity,

[0138] · Distal latency,

[0139] · F wave latency,

[0140] · Motor nerve potential length,

[0141] Those 4 parameters were evaluated for 8 neurons. A change was considered significan...

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PUM

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Abstract

The invention relates to the use of biotin for treating Amyotrophic Lateral Sclerosis, as well as demyelinating peripheral neuropathies and Neuromyelitis optica (NMO).

Description

[0001] The present invention is a divisional application of a Chinese patent application with an application date of March 25, 2016, an application date of "201680018463.8", and an invention title of "Method for Treating Amyotrophic Lateral Sclerosis and Neuropathy". technical field [0002] The present invention relates to the treatment of amyotrophic lateral sclerosis (ALS), and also relates to demyelinating neuropathies (demyelinating neuropathies) and optic neuromyelitis (neuromyelitis optica, NMO). Background technique [0003] Motor neuron diseases (MND) are a group of incurable neurological disorders caused by the selective degeneration of motor neurons. Amyotrophic lateral sclerosis (ALS) or Lou Gehrigs disease is the most representative MND in adults with an incidence of 2-3 per 100,000 / year (Schmitt et al, 2014). It is characterized by progressive muscle weakness and atrophy, loss of upper and lower motor neurons, and ensuing death 3-5 years after diagnosis. [00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4188A61P25/00
CPCA61K31/4188A61P25/00A61K9/0019A61K9/0053A61K45/06A61P21/00A61P25/28
Inventor F.赛德尔
Owner MEDDAY PHARMA
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