Antibodies for and treatment to prevent or reduce the severity o

Details Antibodies for and treatment to prevent or reduce the severity o Antibodies for and treatment to prevent or reduce the severity o

1995-04-17

1999-01-12

Saunders, David

Drug, bio-affecting and body treating compositions

Immunoglobulin, antiserum, antibody, or antibody fragment,...

4241411, 4241521, 4241581, 53038873, A61K 39395, C07K 1642

Patent

active

058583599

DESCRIPTION:

BRIEF SUMMARY
This invention relates to xenograft transplants and more particularly to antibodies and a process for treating a patient to prevent or reduce the severity of xenograft rejection.
As a result of shortages of organs, tissues and cells which are available from humans for transplantation purposes, there have been numerous proposals to obtain organs, tissues and cells from nonhuman animals for transplantation into humans.
As in transplantation procedures involving transplantation of organs from one human to another human, rejection of the nonhuman organ is a serious hurdle to the effective use of xenografts.
It is believed that preformed natural antibodies present in humans are one of the principal causes of xenograft hyperacute rejection. As a result, there have been numerous proposals for removing such preformed natural antibodies.
One such proposal is plasma exchange; however, such technique suffers from the disadvantage that all circulating antibodies and many other proteins are removed, whereby a patient loses many beneficial antibodies, as well as the natural antibodies.
Another proposal is the use of nonspecific absorbants (such as antibodies or naturally occurring substances which recognize the Fc region of an antibody) for removing immunoglobulins from plasma. As with plasma exchange, such a technique removes beneficial antibodies as well as natural antibodies which are believed to cause xenograft or ABO incompatible allograft rejection.
Another method which has been proposed is the use of specific materials for removing the specific natural antibodies which are believed to cause xenograft rejection. Such proposal would involve removal of the natural antibodies against the species which is the source of the xenograft. Thus, for example, if an organ from a swine is to be transplanted into a human, in accordance with this proposal, a material would be used which would specifically remove human anti-swine antibodies. Although such a proposal is theoretically possible, to date, the feasability of such technique has not been demonstrated.
Another method which has been proposed is the use of an antigen which complexes with the antibody against the xenograft, whereby such antibody is no longer free to bind with antigen sites on a xenograft. The resulting complex, however, could potentially have detrimental effects.
As a result, there is a need for new and improved methodology for treating patients to prevent xenograft rejection.
In accordance with an aspect of this invention, there is provided an anti IgM antibody and more particularly an anti-human IgM antibody.
In accordance with another aspect of the present invention, an anti-human IgM antibody is used to lower the levels of natural antibodies which react with a xenograft in a patient who has or is to receive a xenograft.
More particularly, the use of anti-human IgM antibody reduces the level of natural antibodies which react with a xenograft to cause xenograft rejection or ABO allograft rejection, without eliminating beneficial non-IgM antibodies.
The natural antibodies which result in xenograft rejection are mainly of the IgM class whereby the use of an anti-human IgM antibody will lower blood levels of the natural antibodies which are xenoreactive to thereby minimize or eliminate xenograft rejection or ABO allograft rejection.
In accordance with a further aspect of the present invention, the anti-human IgM antibodies are anti-human Mu chain antibodies which react with the mu chain portion of the constant region of human antibodies, with such mu chain being characteristic of an IgM antibody. Such anti-human IgM antibody may be used to lower the serum levels of IgM xenoreactive natural antibodies.
In accordance with still another aspect of the present invention, a patient is treated to prevent or reduce the severity of rejection of a xenograft from a non-human animal, such as swine by contacting the patients blood with an anti-human antibody which immunoreacts with human natural antibodies against a xenograft from such non-human animal. Thus, for example

REFERENCES:
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Harris, WJ and Emery S. TIBTECH. 11: 42-44, Feb. 1993.
Johnston, PS et al. Transplantation. 54(4): 573-576, Oct. 1992.
Fischel, RJ et al. Transplanation Proceedings. 22(3): 1077-1078, Jun. 1990.
Schwartz, RS and Datta, SK. Autoimmunity and Autoimmune Diseases. in: Fundamental Immunology: Second Edition. WE Paul, ed. Raven Press, New York. pp. 819-866, 1989.

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