Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-04-08
2001-07-03
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C424S400000, C424S451000, C424S464000, C424S489000
Reexamination Certificate
active
06255280
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method for reducing adverse effects of a neural injury by administering to a patient a therapeutically effective amount of cyclosporin A.
BACKGROUND OF THE INVENTION
Severe traumatic brain injuries (TBI) initiate a cascade of events that lead to a plethora of adverse effects including dramatic elevations of intracranial pressure (ICP) and dysfunction of cerebrovascular regulatory mechanisms essential for survival. Ischemic brain injury is observed universally in those patients who die following severe TBI. Intracranial hypertension (IH) following traumatic brain injury is associated with direct effects on cerebral perfusion which may be responsible for secondary ischemia. The contributions of both post-traumatic cerebral edema and alteration in cerebral blood volume to ICP appear to vary based on the length of time after the primary mechanical insult. This combination of vasomotor dysfunction and abnormalities in vascular permeability is characteristic of acute inflammation.
The mortality rate from severe traumatic brain injury (TBI) in the United States alone amounts to 9-30 deaths per 100,000. Those suffering brain injury requiring medical treatment number 160-300 per 100,000, with approximately 20 percent of patients admitted to treatment facilities sustain a moderate to severe degree of injury as measured by the Glasgow Coma Score (GCS) of 3-12. Direct costs of brain injury, including the costs of treatment and long-term care, as well as indirect costs, including disablement and the loss of productivity of brain injury patients and other such costs, are staggering.
One approach to treating severe traumatic brain injuries is with hypothermia, as in U.S. Pat. No. 5,486,204 to Clifton. The procedure includes the introduction of specified medication to reduce the risk of cardiac arrhythmia and a complicated protocol for the treatment which defines time, temperature, rate of change of temperature, the timing of the introduction of medications, and rigidly controlled rewarming to reduce the incidence of rewarming shock in recovering patients.
There exists a need to provide simplified methodology for treating traumatic brain injuries in mammals, including humans. The present invention addresses and solves the problems attendant upon multistep, complicated processes for treating severe traumatic brain injuries.
DISCLOSURE OF THE INVENTION
An object of the present invention is a method of treating a mammal suffering from traumatic brain injury.
Additional objects, advantages and other features of the invention will be set forth in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from the practice of the invention. The objects and advantages of the invention may be realized and obtained as particularly pointed out in the appended claims.
According to the present invention, the foregoing and other objects are achieved in part by a method of treating a mammal, including humans, suffering from traumatic brain injury, which method comprises administering a therapeutically effective amount of cyclosporin A.
Another aspect of the present invention is a pharmaceutical composition for treatment of severe traumatic brain injuries, the composition comprising an amount of cyclosporin A effective for reducing adverse effects of traumatic brain injury and pharmaceutically acceptable carrier.
Additional objects and advantages of the present invention will become readily apparent to those skilled in this art from the following detailed description, wherein embodiments of the invention are described simply by way of illustrating of the best mode contemplated in carrying out the invention. As will be realized, the invention is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
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Uchino et al, “Amelioration by Cyclosporin A of brain damage in transient forebrain ischemia in the rat”, Brain Research, pp 216-226, Aug. 25, 1998.*
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McDermott & Will & Emery
Page Thurman K.
Pulliam Amy E
University of Kentucky Research Foundation
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