Triterpene saponins from soybeans for treating kidney disease

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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C514S033000, C536S005000, C536S018100

Reexamination Certificate

active

06784159

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to methods and compositions for treating kidney disease, in particular polycystic kidney disease.
BACKGROUND OF THE INVENTION
Autosomal Polycystic Kidney Disease (ADPKD) is the most prevalent, potentially fatal, inherited disease affecting the human kidney with a reported incidence of 1 out of every 500 births. It has been estimated that 500,000 persons in North America suffer from this disease of which 30,000-75,000 are Canadians. Worldwide, almost 5 million persons suffer from this debilitating disease. Polycystic kidney disease results in enlarged, cyst-filled kidneys in the abdomen producing severe, unremitting back pain, early and progressive hypertension, frequent urinary tract infections and blood in the urine. PKD also has inflammatory and other clinical components. Approximately 45% of cases can be expected to progress to end-stage renal disease (fatal) before the age of 60, adding to health care costs for dialysis treatment, hospitalization, premature morbidity due to cardiovascular and other disorders, surgeries, etc.
At present, there are no known treatments of PKD other than renal ablation, organ transplantation and cyst decompression, all costly, and sometimes life threatening. There is some evidence that, in adult humans, a slower rate of kidney deterioration is associated with a moderate protein restriction (Oldrizzi, L., et al., 1983., Kidney Int., 271:553). This therapy however, is of limited use in the growing child with PKD.
Previous studies of the inventors have shown that feeding a soy protein isolate (SPI;Supro 675 Plus HG®, Protein Technologies, International, St Louis, Mo.) markedly slowed disease progression in the DBA/2FG-pcy(pcy) mouse model of ADPKD (Tomobe K et al, 1998. Am. J. Kidney Diseases. 31:55-61). However, at that time the identity of the active component of the soy protein isolate was not determined.
In view of the foregoing, there is a need in the art to develop a treatment for polycystic kidney disease.
SUMMARY OF THE INVENTION
The present inventors have determined that soyasaponin B
b
is useful in treating polycystic kidney disease.
Accordingly, the present invention provides a method of treating a kidney disease comprising administering an effective amount of soyasaponin B
b
or an analog thereof to an animal in need thereof.
The present invention also includes pharmaceutical and nutraceutical compositions comprising an effective amount of soyasaponin B
b
or an analog thereof in admixture with suitable diluents or carriers.
The present invention further includes a novel method for the isolation of soyasaponin B
b
.


REFERENCES:
patent: 4217345 (1980-08-01), Shinohara et al.
patent: 4557927 (1985-12-01), Miyake et al.
patent: WO 99/34810 (1999-07-01), None
patent: WO 99/34916 (1999-07-01), None
Shiraiwa et al “Composition and Structure of Group A Saponin in Saponin Seed”, Agric. Biol. Chem. 55(2), 315-322, 1991.*
Shiraiwa et al “Composition and Structure of Group A Saponin in Saponin Seed”, Agric. Biol. Chem. 55(2), 323-331, 1991.*
Shiraiwa et al “Composition and Structure of Group A Saponin in Saponin Seed”, Agric. Biol. Chem. 55(4), 911-917, 1991.*
Philbrick, Diana J. et al “Effect of a soyasaponin-enriched alcohol extract from soy protein isolate on disease progression in mice with polycystic kidney disease”, vol. 10, 1999, pp 85A.*
Shiraiwa, Masakazu, et al. Composition and Structure of “Group A Saponin” in Soybean Seed, Agric. Biol. Chem. 55(2), 315-322, 1991.
Shiraiwa, Masakazu, et al. Composition and Content of Saponins in Soybean Seed According to Variety, Cultivation Year and Maturity, Agric. Biol. Chem. 55(2), 323-331, 1991.
Shiraiwa, Masakazu et al. Compositoin and Structure of “Group B Saponin” in Soybean Seed, Agric. Biol. Chem. 55(4), 911-917, 1991.
Philbrick, DP et al., “Effect of a Soyasaponin-Enriched Alcohol Extract from Soy Protein Isolate on Disease Progression in Mice with Polycystic Kidney Disease”, American Society of Nephrology Meeting, Nov. 7, 1999.
Tomobe K et al., “Effect of Dietary Soy Protein and Genistein on Disease Progression in Mice with Polycystic Kidney Disease”, Am. J. Kidney Diseases 31:55-56, 1998.
Shiraiwa M et al., “Composition and Structure of “Group B Saponin” in Soybean Seed”, Agr. Biol. Chem. 55(4):911-917, 1991.

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