Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector
Reexamination Certificate
1998-07-24
2002-06-18
Zeman, Mary K. (Department: 1631)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
C424S001130, C424S278100, C424S209100, C530S395000, C514S002600, C514S008100, C514S888000
Reexamination Certificate
active
06406698
ABSTRACT:
FIELD OF INVENTION
The present invention provides pharmaceutical compositions comprising:
a) serum amyloid P component in a form capable of binding a virus component, said binding resulting in a reduction of the pathogenic properties of said virus component; and
b) a physiologically acceptable carrier.
The pharmaceutical composition comprises serum amyloid P component (SAP) (a naturally occurring protein) or a binder-functional subunit thereof.
The reduction of pathogenic properties results in prophylaxis, alleviation or cure of infectious diseases caused by said virus component.
Especially preferred are compositions formulated for mucosal administration, e.g. nasal administration.
In particular, the virus component is a virus carbohydrate, e.g. exposed on a viral hemagglutinin, and the binding results in at least a partial blocking of said hemagglutinin.
The virus component may be derived from an orthomyxovirus, e.g. an influenzavirus type A, B or C from humans or animals, a virus from the paramyxoviridae family, e.g. a paramyxovirus, from a herpes virus or from a corona virus.
The invention also provides the use of serum amyloid P component (SAP) for the production of a medicament for the prophylaxis or treatment of virus infectious diseases in human beings or animals. The prophylaxis or treatment is obtained by means of SAP in a form capable of binding at least a part of a virus component causing said infectious disease, said binding resulting in a reduction of the pathogenic properties of said virus component.
According to the present invention, the serum amyloid P component (SAP) is the native protein, the recombinant protein or a binder-functional subunit thereof, the subunit being one or more complete SAP polypeptide chain(s) or a part or parts of the chain comprising the Ca
2+
-dependent carbohydrate binding site(s) or synthetic peptides constructed to contain amino acid sequences contributing to said binding sites.
The infectious disease may be caused by the above-mentioned viruses.
A preferred aspect of the invention relates to a method of preventing infection with influenza virus or a parainfluenza virus and the transmission of said virus by blocking virus infectivity with serum amyloid P component (SAP). In particular, this invention relates to the prophylactic/therapeutic use of SAP in epidemics/pandemics of influenza virus infection in man.
Another aspect of the invention relates to the prophylactic/therapeutic use of SAP in epidemics/pandemics of influenza virus infection in horses, swine, and birds.
For instance for prophylactic treatment of horses the pharmaceutical composition may be contained in a vehicle for nose spray or a nebulizer, which is applied separately to the nostrils, nose or upper respiratory tract.
BACKGROUND OF THE INVENTION (HUMAN BEINGS)
Viral infections are a major cause of serious diseases for which effective prevention or treatment in many cases are still not available. The present invention is concerned with viral infections caused by the families orthomyxoviridae, paramyxoviridae, herpes viridae and corona viridae.
The orthomyxoviridae family include i.a. the orthomyxoviruses influenza viruses types A, B and influenza virus type C. Especially influenza virus type A is a major cause of morbidity and mortality due to respiratory disease, outbreaks of which may occur in world-wide epidemics.
The paramyxovirus genus comprises the four serotypes of human parainfluenza viruses, mumps virus, shipping fever virus of cattle and sheep and the avian parainfluenza virus, Newcastle disease virus. Other viruses from the paramyxoviridae family include the Morbillivirus genus (e.g. measles virus, canine distemper virus and rinderpest virus) and the pneumovirus genus (e.g. human and bovine respiratory syncytial virus). The parainfluenza viruses and respiratory syncytial virus are major pathogens causing severe respiratory tract disease in infants and young children.
The herpesviridae family comprises several important human pathogens. Important members of this family are herpes simplex types 1 and 2, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus and human herpes virus type 6. The human corona viridae cause common colds and have been implicated in gastroenteritis in infants.
The main aspect of the present invention concerns human and animal influenzavirus. A more elaborate discussion of these viruses is therefore deemed proper.
Influenzavirus is a genus of viruses (family orthomyxoviridae) which includes influenza virus type A and influenza virus type B. Both A and B types cause sporadic or epidemic influenza in man; type A strains also cause epizootics in pigs, horses or birds (e.g. fowl plague and swine influenza). The viruses are transmitted via aerosols or water or by direct contact.
The enveloped virions are pleomorphic, ca. 80-120 nm in diameter. The envelope encloses the genome of 8 molecules of linear negative-sense ssRNA (total Mwt ca. 5×10
6
), the RNA forming helical ribonucleoprotein complexes with protein NP. Proteins PB1, PB2 and PB3, which together constitute a transcriptase, are associated with the NP-RNA complex. The envelope is associated with viral matrix protein M1 (which occurs internally, surrounding the nucleoprotein core), M2 protein (an integral membrane protein, product of a spliced transcript of the same genome segment (1) as M1), and the glycoproteins HA (hemagglutinin) and NA (neuraminidase); HA trimers and NA tetramers form spikes and mushroom-shaped projections, respectively, which radiate from the outer surface of the viral envelope (24).
Influenza virus types are divided into subtypes (subgroups) on the basis of antigenic differences in the HA antigens (13 subtypes) and NA antigens (9 subtypes). Each individual virus strain is designated by a formula which indicates the following : type (A, B or C); the animal from which the strain was first isolated (omitted if the host was human); the place of initial isolation; the strain number; the year of isolation; and the particular HA (=H) and NA (=N) antigens. Example: A/duck/Ukraine/1/63(H3N8). In humans, strain A/Singapore/1/57(H2N2)—formerly known as “strain A2”—was responsible for the influenza pandemic of 1957 (“Asian flu”), while Strain A/Hong Kong/1/68(H3N2) was responsible for the 1968 pandemic (“Hong Kong flu”). However, these strains are not immutable; influenza viruses undergo ANTIGENIC VARIATION in their glycoprotein antigenic determinants, allowing the viruses to overcome their hosts' immune responses and resulting in new epidemics of influenza. Two kinds of antigenic variation occur: ANTIGENIC DRIFT AND ANTIGENIC SHIFT. Antigenic shift occurs infrequently and has been recorded only in type A strains. It appears to depend on the fact that type A strains can infect animals as well as man, and that, in mixed infections involving strains from different species, genome segments may undergo reassortment, allowing the generation of new virus subtypes (25). Since 1946, three distinct human subtypes —H1N1, H2N2 and H3N2—have arisen, each causing a new pandemic of influenza and each largely replacing its predecessor. Each prevailing subtype has also undergone regular antigenic drift (as a result of small mutational changes in HA and NA antigens), each new variant causing outbreaks and epidemics of influenza. Antigenic drift also occurs, though more slowly, in B- and C-type influenza viruses.
Influenza virus C is also a virus of the ORTHOMYXOVIRIDAE. It is physicochemically and morphologically similar to members of the genus Influenzavirus, but differs in containing only 7 RNA segments (total Mwt ca. 4-5×10
6
) and in having only one type of surface glycoprotein (HA) which has both haemagglutinating and receptor-destroying activities, but apparently no neuraminidase activity. It has recently been shown that, contrary to previous assumptions, sialic acid may nevertheless be an essential component of the host cell-surface receptor (26). Influenza virus C primarily infects man, although it has been isolated from pigs in China; i
Andersen Ove
Nielsen Ellen Holm
Svehang Sven-Erik
Darby & Darby
Profylakse Aps
Zeman Mary K.
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