Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1994-09-27
2003-07-01
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06586443
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the treatment of certain chronic diseases; namely, chronic infections caused by herpes virus, both herpes simplex virus and Epstein-Barr virus, chronic long-term inflammatory disease of the connective tissue, chronic fatigue syndrome and multiple sclerosis, by, the low dose administration of an essentially pure opiate receptor antagonist, such as naltrexone and naloxone.
BACKGROUND OF THE INVENTION
In our application Ser. No. 129,862, and now U.S. Pat. No. 4,888,346, we disclosed and claimed the treatment of humans infected with HTLV-III (AIDS) virus, including clinically diagnosed AIDS and AIDS-related complex (ARC), by the administration at low dosage levels of an essentially pure opiate receptor antagonist, preferably such antagonist having preferential blocking activity for Mu over Delta opiate receptor sites and exhibiting at the contemplated low dosage level a substantially selective blocking activity for Mu over Delta receptor sites, exemplified by naltrexone and naloxone. The patent literature relating to the medical utility proposed at the time for these and related drugs is summarized in the introductory discussion of the earlier application, the complete contents of which are hereby incorporated by reference, and include the treatment of narcotic addiction and narcotic overdose, the relief of severe itching in conjunction with Hodgkins Disease, mycosis funoides, severe jaundice, and various types of pruritis, the treatment of anorexia, the treatment of medical shock; i.e., anaphylactic, burn, cardiac, and the like shock, and the treatment of alcoholism or alcoholic intoxication.
As explained in the prior applications, essentially pure opiate receptor antagonists, exemplified by naltrexone and naloxone, appear to be effective in potentiating the natural human immune system against the HTLV-III (AIDS) virus, apparently by up-regulation of the endorphinergic system to thereby enhance hemostatic regulation of the natural immune function or the human body in ways by no means adequately understood. It has now been discovered that surprisingly these drugs are likewise effective for the treatment of certain chronic long-term diseases for which a specific medical treatment has been largely unavailable up to now, and even their etiology is, in a majority of instances, unknown.
DETAILED DESCRIPTION OF THE INVENTION
The diseases with which the invention is particularly concerned are listed below, together with a summary description of their pertinent medical features.
CHRONIC HERPES VIRUS INFECTIONS
The important herpes virus infections are chronic genital herpes and chronic infections due to the Epstein-Barr virus (EPV). Genital herpes is a highly prevalent disease caused by the herpes simplex virus (HSV) type No. 2, transmitted from person to person by direct contact. The disease typically begins with a genital rash and mild itching which develops into vesicular lesions appearing mainly on the genitalia and adjacent body regions, which lesions can expand to an ulcerated condition, which can be accompanied by a general malaise, fever and anorexia. Neurological complications are possible but rare. The disease is often self-limiting and may disappear after a single episode or, more typically, can reoccur in milder and less frequent episodes; but for some, it can be become chronic with severe and painful episodes at weekly or monthly intervals. Such episodes can be precipitated by stress, trauma, menstrual hormone changes, etc. The chronic disease is usually associated with high levels of serum antibodies against HSV. There is presently no cure for genital herpes. Treatment with the anti-viral drug, acylovir, administered in topical form appears to limit episodic duration but does not effect a cure, prevent transmission or protect against subsequent reoccurance. Otherwise, treatment is generally palliative. Substantial risk exists for infants delivered by normal birth from infected mothers; neonatal herpes can cause brain damage and possible death.
EBV is the cause of infectious mononucleosis which occurs mainly in late adolescence and young adults by transmission of the virus through direct oral contact. Its symptoms are “flu-like” and mainly include headache, sore throat, muscle soreness, swollen glands, and general fatigue and weakness. These symptoms usually dissipage within a few weeks and treatment consists mainly of rest and curtailed activities combined with analgesic administration to relieve pain and soreness, there being no curative treatment known. Occasionally, the condition becomes recurrent or chronic which is particularly indicated by serological evidence of EBV and a significant increase in lymphocytes, with a large atypical fraction. In chronic cases, the “flu-like” symptoms may persist for a considerable period, and it is this category with which the invention is concerned.
CHRONIC INFLAMMATORY CONNECTIVE TISSUE DISEASE
The most important inflammatory connective tissue diseases are rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
RA is an inflammatory disease affecting the connective tissue of the joints and elsewhere in patients of all ages but mainly between 20 and 40. It occurs about equally in both sexes but with a considerably higher liklihood of severity in females. It begins typically in mild form with one or more joints becoming painfully inflamed and stiff accompanied by malaise, fever and weight loss. For some the episodes may be mild and separated by lengthy remissions, but more generally the episodes become more severe and frequent in a continuing pattern of remissions and exacerbations. Its cause is unknown, and opinion is divided over whether it is due to an autoimmune reaction of the body, infection by some unidentified virus or bacteria, or an inherited genetic predisposition. The chronic form can lead to both cartilage destruction and loss of muscle control at the joint. Degenerative effects may also occur in the collagen in various bodily organs. Curative treatment is unknown; treatment is symptomatic and usually involves the administration of anti-inflammatory drugs, most commonly aspirin. The objective is mainly to achieve tolerance and acceptance by the patient with activity aimed at maintaining joint mobility.
Systemic lupus erythematosus is a chronic inflammatory disease of connective tissue throughout the body and usually appears in a pattern of remissions and acute episodes. It occurs primarily in females, mainly of childbearing age, but any age can be affected, being about eight times more prevalent in females than in males. The black race is several times more susceptible than the white race. SLE is a syndrome and can affect various organs of the body; it is usually manifested by fever, weight loss, joint pain, skin lesions and rash, Renal, cardiovascular and pulmonary complications are common. Its origin is unknown but apparently is due to an inexplicable defect in the immune system. Contributing factors include exposure to ultraviolet radiation; e.g., from sunlight, infection and hormonal effects. No treatment is known; anti-inflammatories or analgesics are given for symptomatic relief together with corticosteroids and in extreme cases immunosupressive agents,
MULTIPLE SCLEROSIS
MS is a chronic neurological disease resulting in destruction of the myelin covering of nerve cells, particularly of the brain and spinal cord. It affects men and women equally, mainly between the ages of 20 and 40. Etiological evidence is mixed. Certain evidence suggests an infectious (viral) factor since occurrence is far more common in temperate regions than in tropical regions. Other evidence suggests autoimmune involvement changes in the seriology of the autoimmune system being usually evident prior to acute attacks. Still further evidence suggests a genetic predisposition, persons of Oriental and African ancestry being generally free of the disease independently of origin of birth. Or a combination of all three could be involved in that exposure to a virus at an early age, by which most
Bihari Bernard
Drury Finvola
Daniel William J.
Travers Russell
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