Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Liposomes
Reexamination Certificate
1999-12-03
2001-07-17
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Liposomes
C424S581000, C514S078000, C514S900000, C604S058000, C604S058000
Reexamination Certificate
active
06261597
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods for improving the periodontal health of a subject by intravenous administration of a suspension of liposomes. The invention also relates to methods for improving hair regrowth of a subject by intravenous administration of a suspension of liposomes.
REFERENCES
Amselem, S., et al.,
LIPOSOME TECHNOLOGY
(Gregoriadis, G., Ed.), pp. 501-524, CRC Press, Boca Raton, Fla. (1993).
Barenholz, Y., et al.,
Biochemistry
16:2806 (1977).
Barenholz, Y., et al.,
LIPOSOME TECHNOLOGY
(Gregoriadis, G., Ed), pp. 524-607, CRC Press, Boca Raton, Fla. (1993).
Daida, H., et al.,
Am. J. Cardiol.
73(15):1037-1040 (1994).
Desmarais, R. L., et al.,
Circulation
91(5):1403-1409 (1995).
Groop, P. H., et al.,
Diabet. Med.
11(10):961-967 (1994).
Harrison, T. R., Ed.,
HARRISON'S PRINCIPLES OF INTERNAL MEDICINE, TWELFTH EDITION,
pp. 1001-1015, McGraw Hill, Inc. (1991).
Kokoglu, E., et al.,
Cancer Biochem. Biophys.,
14(2):133-136 (1994).
Levida, M.,
HANDBOOK OF NUTRITION IN THE AGED
(Watson, R. R., Ed.), CRC Press, pp. 89-109 (1985).
Shinitsky, M., et al.,
J. Biol. Chem.
249:2652 (1974).
Szoka, F., et al.,
Ann. Rev. Biophys. Bioeng.
9:467 (1980).
Takahashi, S., et al.,
Ann. Rheum. Dis.
54(2):90-93 (1995).
Tenda, K., et al.,
Jpn. Circ. J.
57(8):789-795 (1993).
Yamamoto, K., et al.,
Metabolism
44(1):4-7 (1995)
BACKGROUND OF THE INVENTION
There are several classes of globular, lipid-containing particles, known as lipoproteins, that circulate in human blood and transport nonpolar lipids, primarily triglycerides and cholesteryl esters, through the plasma. Lipoproteins are classed according to the composition of the nonpolar lipids in the core of the particle and according to the composition of the apoproteins on the surface, and the density size and electrophoretic mobility of the lipoprotein (Harrison, 1991).
Recent studies have shown various disease associations with above-normal or sub-normal levels of certain lipoproteins. It is known, for example, that serum Lp(a) is elevated in subjects with gout (Takahashi, et al., 1995), various types of cancer, such as breast cancer (Kokoglu, et al., 1994), hyperthyroidism (Yamamoto, et al., 1995), and in Type 1 diabetics with early and established renal disease (Groop, et al., 1994). It has also been shown that there is a direct correlation between development of post-angioplasty restenosis and elevated serum Lp(a) concentrations (Tenda, et al., 1993).
SUMMARY OF THE INVENTION
In one aspect, the invention includes a method of reducing the Lp(a) concentration in a subject at risk for developing a disease condition associated with a chronic, elevated Lp(a) concentration, such as gout, breast cancer, hyperthyroidism, coronary heart disease or cerebral vascular disease. The method includes intravenously administering to the subject a suspension of small unilamellar liposomes composed primarily of phosphatidylcholine phospholipids having phase transition temperatures in the range between about −10 and 37° C., preferably a transition temperature of less than about 50° C., as exemplified by egg phosphatidylcholine (egg PC) which has a transition temperature of −5° C.
The liposomes in the composition are small unilamellar vesicles (SUV's), i.e., vesicles having sizes predominantly between 0.02 and 0.12 microns, and preferably 0.02-0.08 microns. The liposome suspension is administered at a dose of between about 50-1,000 mg lipid/kg body weight. Multiple treatments may be given, e.g., at least once a week, over a several week period. Treatment is carried out until a desired reduction in Lp(a) level is observed.
The treatment method may also be applied to a person having an elevated Lp(a) serum concentration and a disease, such as gout, breast cancer or hyperthyroidism, cerebral vascular disease, and coronary heart disease associated with such elevated concentrations.
In another aspect, the invention provides a method of inhibiting restenosis in a subject, following percutaneous transluminal coronary angioplasty or surgical resection of vascular tissue. The method includes administering liposomes, as described above, until a reduction in serum Lp(a) concentration is observed.
In another aspect, the invention includes a method of achieving hair regrowth in a person suffering from male pattern baldness or alopecia, and a method of improving the periodontal condition in a person having symptoms of periodontal disease, such as gingivitis, tooth mobility or bone loss.
In both methods, a suspension of liposomes of the type described above is administered until a significant improvement in the condition is observed.
These and other objects and features of the invention will be more fully appreciated when the following detailed description of the invention is read in conjunction with the accompanying drawings.
REFERENCES:
patent: 4812314 (1989-03-01), Barenholz et al.
patent: 5324520 (1994-06-01), Dunn et al.
patent: 5489611 (1996-02-01), Lee et al.
patent: 5622715 (1997-04-01), Barenholz et al.
patent: 5965157 (1999-10-01), Li et al.
Williams, K.J., Werth, P. and Wolff, J.A. Intravenously administered lecithin liposomes: a synthetic antiatherogenic lipid particle. 1984. Perspectives in Biology and Medicine, 27, 3, pp. 417-431.
Di Nola-Baron Liliana
Foley & Lardner
Page Thurman K.
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