Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-08-17
2001-09-18
Cook, Rebecca (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06291493
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a new medical use of 5-(2-chloroethyl)-4-methylthiazole and the pharmaceutically acceptable salts and solvates thereof and pharmaceutical compositions containing it.
5-(2-chloroethyl)-4-methylthiazole is also known as clomethiazole, chlormethiazole, chlomethiazole, BAN Chlormethiazole and INN Clomethiazole. For the sake of simplicity the expression “clomethiazole” is used throughout the specification.
In particular, the present invention relates to the use of clomethiazole for the prevention and/or treatment of spinal cord injury.
BACKGROUND TO THE INVENTION
Preparations containing clomethiazole, particularly in the form of its acid addition salts, especially the acid addition salt with 1,2-ethanedisulfonic acid are known to possess valuable therapeutic properties. The general pharmacology and therapeutic applications of clomethiazole have been extensively reviewed in recent publications (see Acta Psychiatr Scand 73 (suppl 329), 1986; Progr. Neurobiol. 44, 463-484 (1994).Thus, for example, clomethiazole possesses sedative and hypnotic properties and is used clinically as a hypnotic in the elderly, particularly in the management of psychogeriatric patients. Clomethiazole also possesses anticonvulsant properties and is used clinically for the treatment of different types of convulsive states, such as, for example, status epilepticus and pre-eclampsias. Clomethiazole is also used clinically for the treatment of ethanol (alcohol) withdrawal states including delirium tremens. U.S. Pat. No. 5,399,572 discloses the use of clomethiazole in the prevention and/or treatment of neurodegeneration in pathological conditions such as stroke, cerebral ischaemia, hypoxia, epilepsy and neurodegenerative diseases such as Alzheimer's disease, multi-infarct dementia and Huntingdon's disease.
DESCRIPTION OF THE INVENTION
The present invention relates to the use of clomethiazole for the prevention and/or treatment of spinal cord injury.
In particular, the invention relates to the use of clomethiazole and the pharmaceutically acceptable salts and solvates thereof, in the prevention and/or treatment of pathological conditions caused by compression, either vertical or lateral, to the spinal cord, whether traumatically induced or due to compression due to other causes such as tumours, haemorrhage, infectious processes or spinal stenosis. Trauma may also induce spinal cord injury in the absence of any persistent compression of the cord. Impaired blood supply causing signs of spinal cord ischemia or infarction may also cause tissue destruction in the spinal cord.
Acute ischaemic stroke and its treatment differs substantially from trauma and other conditions which may entail compression of the spinal cord. The major existing treatment for traumatic spinal cord injury (methylprednisolone) is not an effective treatment for stroke. On the other hand, several compounds that are effective in stroke models are also effective in spinal cord compression injury models. Whether these compounds work in the clinic is unknown.
The present invention can be distinguished from the above prior art in that it is concerned with a new medical use which is unexpected and which can be clearly distinguished from the applications in the above described disorders. Given the current treatment for non-penetrating spinal cord injury (dexamethasone), usefulness of clomethiazole in any of the aforementioned indications could not lead to the suggestion that it should be useful in non-penetrating spinal cord injury.
REFERENCES:
patent: 9009174 (1990-08-01), None
Biosis AN 999:81187, Farooque et al, Society for Neuroscience Abstracts, vol. 24,(1-2). abstract, 1998.*
Hedlund, B. et al. Chlormethiazole acts on chloride channels in cultured spinal cord neurons.Neuroscience Letters78:217-221, 1987.
Smith, A. M. Emergencies in Palliative Care.Annals of the Academy of Medicine(Singapore), 23 (2): 186-190, 1994.
Gurusinghe, N. T. et al. Chlormethiazole in the management of post-craniotomy seizures. ActaPsychiatr. Scand.Suppl. 339, 73: 189-193, 1986.
Green, A. R. The Neuroprotective Actions of Chlormethiazole.Progress in Neurobiology44: 463-484, 1994.
Farooque Mohammad
Jackson David
Olsson Yngve
Astrazeneca AB
Cook Rebecca
White & Case LLP
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