Systemic administration of NAC as an adjunct in the treatment of bioterror exposures such as anthrax, smallpox or radiation and for vaccination prophylaxis, and use in combination with DHEA for the treatment of smallpox and other viruses

Abstract

The invention is for the combination and related methods of N-acetyl-cysteine oral, inhaled, or intravenous, or glutathione inhaled or intravenous, generally in combination with antibiotic and / or antiviral therapy to ameliorate the toxic effects of infection with materials used in Bioterror incidents such as Bacillus anthracis and smallpox virus, and alternatively, upon exposure to radiation, during testing, and vaccination, as treatment prior to treatment with antibiotic or antiviral therapy to ameliorate the toxic effects of infection and exposure with these organisms.

Description

CONTINUATION DATA[0001] This application is a continuation in part of provisional application 60 / 338,267 filed on Nov. 9, 2002 entitled Systemic Administration Of Glutathione Or Precursor Such As NAC As An Adjunct In The Treatment Of Bacillus Anthracis Exposure Or Infection, of provisional application 60 / 371,590 filed on Apr. 11, 2002 entitled Use Of Glutathione Precursor In The Treatment Of Smallpox And The Use Of Glutathione Precursor In The Treatment Of Radiation Exposure, The Use Of The Combination Of Glutathione Precursor And DHEA For The Treatment Of Smallpox And Other Viruses, and of a provisional application being filed this day with the above title, all of which are incorporated by reference herein.[0002] The invention is for the combination of N-acetyl-cysteine oral, inhaled, or intravenous, or glutathione inhaled or intravenous, and antibiotic and / or antiviral therapy to ameliorate the toxic effects of infection with materials used in Bioterror incidents such as Bacillus ...

AI Technical Summary

Benefits of technology

[0041] Another object is to enable treatment of multiple vector exposure without fear of toxicity of individuals and without fear of compromising later desired treatments, particularly useful where a number of threats may be combined.

[0042] Another object is that in the event of mass attack, not everyone will be exposed or present with symptoms, and this invention, utilizing NAC, enables some treatment by purchasing economically in relatively vast quantities enabling more optimal use of more limited and considerably more expensive antibiotic, anti-viral and vaccination resources.

[0046] For patients with inhalation anthrax, for whom the prognosis is very poor, the addition of IV NAC offers one of the few non-toxic detoxification regimes to interrupt the dramatic and life-threatening effect of toxin release and apoptotic effect triggered by Bacillus anthracis.

[0047] The invention also can give partial protection against changes by bioterrorists to the anthrax activity because the invention combats through natural metabolic pathways the toxin effect whatever the strain of anthrax that is the source. Such sources may change because of the emergence of antibiotic resistant strains either through natural selection or the introduction of antibiotic resistance through genetic manipulation by manufacturers of bioterror weapons.

Problems solved by technology

In cases of pulmonary anthrax, peribronchial hemorrhagic lymphadenitis blocks pulmonary lymphatic drainage, leading to pulmonary edema.

It is postulated that the macrophage accumulates the IL-1 until a critical level of toxin is reached which causes lysis of the cell and uncontrolled release of the accumulated IL-1 in a large amount that can lead to shock and death.

Dixon, Meselson, Guillemin and Hanna, "Anthrax," N. Engl. J. Med. 341(11): 815-26, Sep. 9, 1999 specifically note "Unfortunately, anti-toxin preparations are not currently available in the United States.

Viruses cause problems by changing the machinery of the cell that it has commandeered and by creating so many copies of itself that the cell cannot maintain its normal function, ceases functioning normally and may even rupture, releasing large amounts of virus.

The pustules then dry up and shrink, leaving a hard crust that eventually flakes off leaving a sunken scar.

As a biological weapon, smallpox represents a serious threat as it has been reported to carry a case-fatality rate of 30% or more in unvaccinated populations.

The increase in oxidation decreases the available glutathione.

Thus, it may be difficult to identify the etiologic cause of the early stage symptoms of biological weapons or radiation.

Additional factors also play a role in limiting the individual's ability to combat infection.

Stress will also lower the response to vaccination and decrease protection to subsequent infection challenge in pigs immunized with a viral vaccine.

No patent, however, has claimed the use of a combination of NAC and DHEA or its metabolite AED as an immune enhancing combination for the treatment of viral diseases such as smallpox.

As the presence of viral infection will decrease the level of glutathione it is likely that the immunization response may be compromised in individuals who are already carrying smallpox.