Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2001-09-13
2003-07-22
Swartz, Rodney P (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S009100, C424S009200, C424S184100, C424S204100, C424S225100, C424S229100, C424S234100
Reexamination Certificate
active
06596282
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the use of
M. vaccae
in the treatment of viral infections, particularly chronic viral infections.
BACKGROUND TO THE INVENTION
British Specification No. 2156673 (International Patent Specification WO85/03639) describes immunotherapeutic agents comprising killed cells of
M. vaccae
. These agents are useful in the immunotherapy of mycobacterial disease, especially tuberculosis and leprosy. It is stated that use of this immunotherapeutic agent facilitates the removal of the persisting bacilli responsible for tuberculosis or leprosy which, as is well known, it is difficult to remove by chemotherapy alone.
International Patent Specification PCT/GB85/00183 (WO85/05034) describes compositions for the alleviation of the symptoms of, and for the treatment or diagnosis of, arthritic disease which comprise as active ingredient the whole organism of
M. vaccae
. It is stated that the preparations of
M. vaccae
are useful for the treatment of various autoimmune diseases and especially arthritic conditions including rheumatoid arthritis, ankylosing spondylitis or Reiter's syndrome.
Other uses of
M. vaccae
are described in, inter alia, WO91/02542, which refers to compositions comprising antigenic and immunoregulatory material derived from
M. vaccae
as being generally useful in the treatment of pathological conditions in which the proportion of agalactosyl IgG (i.e. IgG which lacks terminal galactose from the N-linked oligosaccharides on the heavy chains) is increased, WO92/08484, which refers to the use of
M. vaccae
for the treatment of uveitis, WO94/06466, which provides the use of antigenic and/or immunoregulatory materials derived from
M. vaccae
for the manufacture of a medicament useful in the therapy of AIDS and also in the therapy of HIV-positive asymptomatic patients, and South African patent application 95/2644, which teaches that immunotherapy with
M. vaccae
is expected to be effective against tumours of mesodemal, endodermal and ectodermal origin, including breast and bronchial tumours.
The therapeutic agent conveniently, and therefore preferably, comprises dead cells of
M. vaccae
, most preferably cells which have been killed by autoclaving, although WO92/08488 further discloses that killed cells of
M. vaccae
can be used to stimulate and/or modify in a favourable way the immune response to antigens which are not endogenous to
M. vaccae.
International application PCT/GB98/03346 teaches that cold-shocked
M. vaccae
preparations may be obtained which comprise proteins induced by cold-shock treatment and that such preparations have a variety of uses, including but not limited to the treatment of diseases such as Raynaud's syndrome or hypothermia.
DISCLOSURE OF THE INVENTION
We have surprisingly found that treatment of chronic viral infections with
M. vaccae
is beneficial to the course of the infection, in either stabilizing the infection or providing partial or complete clinical improvements.
The action of
M. vaccae
against viral diseases in humans or other animals is surprising in that the action of this bacterial antigen induces a response to cells infected at a distant site by a virus.
The present invention thus provides a method of treating a chronic viral infection, excluding an HIV infection, which method comprises administering to a human or animal subject in need of treatment an effective amount of an
M. vaccae
preparation. The action against these non-HIV chronic viruses may be distinguished over the action against HIV in that HIV directly attacks the host immune system which is believed to be modulated by the action of
M. vaccae.
The invention further provides the use of an
M. vaccae
preparation for the manufacture of a medicament for use in the treatment of a chronic viral infection, excluding an HIV infection.
DETAILED DESCRIPTION OF THE INVENTION
Certain viruses can enter specific cells, change the function of the cells to produce viral proteins and express stress proteins, without killing them. Such viruses slowly replicate within the infected host cells and such infection may cause chronic or relapsing disease, and may also produce clinical lesions. Thus by “chronic viral infection”, is meant a viral infection of humans or other animals which is able to infect a host and reproduce within the cells of a host over a prolonged period of time—usually weeks, months or years, without proving fatal.
Amongst viruses giving rise to chronic infections and which may be treated in accordance with the present invention are the human papilloma viruses (HPV), Herpes simplex and other herpes viruses, the viruses of hepatitis B and C as well as other hepatitis viruses, and the measles virus, all of which can produce important clinical diseases. Prolonged infection may ultimately lead to the induction of disease which may be, e.g. in the case of hepatitis C virus liver cancer, fatal to the patient.
Papilloma viruses in man give rise to four different presentations of warts. Sporadic warts, usually on the hands, plantar warts of the foot, multiple warts in which scattered large areas of skin are involved in confluent warty excrescences, often involving the pudenda (venereal warts) and papilloma virus associated dysplasia of the uterine cervix, quite often without other lesions. The first two of these are usually minor, self-resolving or easily treated by topical measures. The second two are much more difficult to treat and usually persist lifelong to varying degrees. Cervical dysplasia is a well known premalignant condition and is the major reason for the cervical smear programme. There are at least 75 types of HPV that can be distinguished. Solitary lesions are usually associated with a single type, multiple lesions are often found to be due to several different types of virus at the same time, venereal warts and cervical dysplasia are often associated with types 16, 18 or 31 virus. These types, as well as other HPV subtypes, e.g. HPV2
a
and HPV21 may be treated in accordance with the present invention.
The herpes simplex virus HSV-1 causes the common condition known as “cold sores” in which small raised or ulcerated lesions occur several times a year, at the mucocutaneous junction between the buccal or nasal mucosa and the surrounding skin. Frequently the lesions occur when immunity is impaired by acute virus infections. The viruses survive longterm in small nerve endings. The HSV-2 virus can also give rise to genital herpes in which extensive lesions occur around the mucocutaneous junction between the glans penis and prepuce or around the vulva. In both sexes genital herpetic lesions tend to be much more extensive and severe than are cold sores. Fluctuating from time to time, genital herpes is much more persistent than are cold sores. Again, the virus becomes established in small nerves from which it continuously reinfects the pudendal regions. The present invention provides for treatment of both HSV-1 and HSV-2 infection, as well as for the treatment of other herpes viruses.
Hepatitis B and C viruses are usually, though perhaps not solely, transmitted from person to person with blood products. Both give rise to an acute hepatitis that in some people resolves without further problems and in others becomes chronic. Chronic hepatitis results in slow cirrhosis is of the liver that may lead to death due to liver failure or to development of malignant hepatomas. Neither disease is at all easily treated.
Very rarely the measles virus can become established chronically in the brain and give rise to a progressive and fatal condition called subacute sclerosing pan-encephalitis (SSPE), for which there is no known treatment.
Other chronic viral infections which may be treated in accordance with the present invention include Epstein Barr virus (EBV), as well as other viruses such as those which may be associated with tumours, or in the case of animals, various veterinary viral diseases, for example those of domestic pets or farmyard animals important in agriculture.
It will be understood that the actio
Rook Graham A. W.
Stanford Cynthia A.
Stanford John L.
Nixon & Vanderhye P.C.
Stanford Rook Limited
Swartz Rodney P
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