Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Extracorporeal or ex vivo removal of antibodies or immune...
Patent
1995-06-08
2000-03-21
Saunders, David
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Extracorporeal or ex vivo removal of antibodies or immune...
210630, 210645, 210646, 210648, 210651, 210660, 210661, 210670, 210688, 604 5, 604 6, A61K 3900, A61M 3700
Patent
active
060399465
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to extracorporeal devices for binding substances in a fluid. The devices have particular but not exclusive application in the treatment of disease states wherein the fluid is drawn from and returned to a mammal.
BACKGROUND OF THE INVENTION
Atherosclerosis and cancer are the two major causes of morbidity and mortality in western societies. While there has been significant advance in the treatment of atherosclerosis there is still a great need for more effective treatment interventions.
The main mechanism by which atherosclerosis leads to morbidity and mortality is by narrowing the lumen of arteries and reducing the blood supply to the heart, brain and other vital organs. The factors associated with atherosclerosis include: High levels of cholesterol, triglycerides, low density lipoproteins (LDL) and low levels of high density lipoproteins (HDL).
Other factors are heredity, cigarette smoking, obesity, high blood pressure, reduced physical activity, high fat diets, and a high oxidation activity associated with the production of free radicals, leading to the oxidation of LDL, which accelerates the development of atherosclerotic lesions. Thus, J. Regnstrom et al., Lancet, Vol. 339, No. 8803, May 16, 1992, pp. 1183-86, reported that the susceptibility of LDL to in vitro oxidation in the presence of copper, which acts as a catalyst in the oxidation process, was correlated with the severity of their coronary artery sclerosis. J. T. Salonen et al, Lancet, Vol. 339, No. 8798, Apr. 11, 1992, pp. 883-87, found that the level of autoantibodies to oxidized LDL predicted the progression of atherosclerosis of the carotid artery (the artery that supplies blood to the brain). One likely mechanism in development of atherosclerotic lesions via the oxidation of LDL is the induction of an autoimmune process leading to the production of antibodies specific to oxidized LDL and propagation of the atherosclerotic lesion by the autoantibody binding to oxidized LDL. J. Regnstrom et al., supra, and T. Kita et al., Proceedings of the National Academy of Sciences USA, Vol. 84, 1987, pp. 5928-31. J. T. Salonen et al., Circulation, Vol. 86(3), September 1992, pp. 803-11 reported an association between the risk of heart attack and the level of iron in the blood, with the risk being particularly high when plasma levels of both iron and LDL were elevated.
A significant reduction in blood levels of LDL and cholesterol by diet and lipid reducing drugs was found to result in regression of atherosclerosis. G. Brown et al., New England Journal of Medicine, Vol. 323(19), Nov. 8, 1990, pp. 1289-1298. Oral lipid lowering drugs, such as Lovastatin, MSD (Mevacor.RTM., Merck), are risky and may cause liver damage. Their efficacy is relatively limited, even when they are taken in association with a strict diet. Lowering of LDL by extracorporeal treatment of blood, M. Strahilevitz, U.S. Pat. Nos. 4,375,414 and 4,813,924, and M. Strahilevitz, Atherosclerosis, Vol. 26, 1977, pp. 373-77, is significantly more effective in reducing blood cholesterol and LDL levels. H. Borberg et al., Journal of Clinical Apheresis, Vol. 4, 1988, pp. 59-65; R. L. Wingard et al., American Journal of Kidney Diseases, Vol. 18(5), 1991, pp. 559-65; V. Hombach et al., Dtsch Med. Wschr, Vol. 111(45), 1986, pp. 1709-15. LDL and cholesterol can be removed by affinity adsorption, utilizing as the adsorbent antibodies to LDL or other specific chemical adsorbents, such as dextran sulphate (M. Odaka et al., International Journal of Artificial Organs, Vol. 9, 1986, pp. 343-48) or heparin (D. J. Lupien et al., Pediatric Res., Vol. 14, 1980, pp. 113-17). LDL removal can also be achieved by heparin precipitation (D. Seidel et al., Journal of Clinical Apheresis, Vol. 4, 1988, pp. 78-81), and by double filtration plasmapheresis (S. Yokoyama et al., Arteriosclerosis, Vol. 5, Nov./Dec. 1985, pp. 613-22) as well as by plasma exchange (G. R. Thompson, Lancet 1981 I, pp. 1246-48).
The oral administration of vitamin E is associated with lower risk of
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