Use of interleukin-4- for lowering blood-cholesterol levels

Details Use of interleukin-4- for lowering blood-cholesterol levels Use of interleukin-4- for lowering blood-cholesterol levels

1991-06-10

1993-02-23

Lee, Lester L.

Drug, bio-affecting and body treating compositions

Lymphokine

Interleukin

424 851, A61K 4505

Patent

active

051888270

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

This invention relates to the lowering of blood cholesterol levels in mammals by administering a cholesterol lowering effective amount of interleukin-4 (IL-4).
Interleukin-4 (IL-4) is a lymphokine (stimulator of the immune system) that has a broad range of immune cell stimulation as described in Banchereau et al., Lymphokine Res. Vol. 6, No. 1: U135 (1987); Yokoto et al., Proc. Natl. Acad. Sci. USA, 83: 5894-5898 (1986); Lee at al., Proc. Natl. Acad. Sci. USA, 83: 2061-2065 (1986); Coffman et al., J. Immunol. 136: 949-954 (1986); Sanderson et al., Proc. Natl. Acad. Sci. USA, 83: 437-440 (1986); Grabstein et al., J. Exp. Med., 163: 1405-1413 (1985); and Vitetta et al., J. Exp. Med. 162: 1726-1731 (1985). During its early development IL-4 has also been referred to as B-cell growth factor (BCGF) [Butler et al., J. Immunol. 133: 251-255 (1984)(human BCGF); and Farrar et al., J. Immunol. 131: 1838-1842 (1983)(mouse BCGF)] and B-cell stimulatory factor 1 (BSF-1) [Ohara et al., J. Immunol. 135: 2518-2523 (1985)]. The clarification and designation of the name interleukin-4 was finally proposed and adopted in 1986 [Sanderson et al., Proc. Natl. Acad. Sci. USA, 83: 437-440 (1986)].


SUMMARY OF THE INVENTION

The method of this invention involves administering to mammals a serum cholesterol lowering effective amount of IL-4. Preferably, the IL-4 is administered to mammals diagnosed as having elevated blood serum cholesterol levels (hypercholesterolemia). The invention also relates to the use of IL-4 for the manufacture of a medicament for lowering blood serum cholesterol levels.
Preferably, the IL-4 employed is derived from a human source. Preferably the dosage form is one suitable for administration by intravenous injection or intravenous infusion and administration will suitably be in an amount of about 0.5 to about 600 micrograms of IL-4 per kilogram of body weight per day. Preferably, the IL-4 is administered in an amount of about 0.5 to about 125 micrograms of IL-4 per kilogram of body weight per day, and most preferably about 0.5 to about 30 micrograms of IL-4 per kilogram of body weight per day.


DESCRIPTION OF THE DRAWING

FIGS. 1a-d illustrate a construction map for the expression of human IL-4 in the vector pdhfr-SRalpha263.


DETAILED DESCRIPTION OF THE INVENTION

The invention provides a method for lowering blood cholesterol levels in mammals, e.g., mammals with hypercholesterolemia, by administering to said mammals a serum cholesterol lowering effective amount of IL-4. The invention also provides for the use of IL-4 for the manufacture of a medicament for lowering blood serum cholesterol levels.
Any suitable IL-4 may be employed in the present invention. Complementary DNAs (cDNAs) for IL-4 have recently been cloned and sequenced by a number of laboratories, e.g. Yokoto et al., Proc. Natl. Acad. Sci. USA, 83: 5894-5898 (1986) (human); Lee at al., Proc. Natl. Acad. Sci. USA, 83: 2061-2065 (1986)(mouse); Noma et al., Nature 319: 640-646 (1986)(mouse); and Genzyme Corporation, Boston, Mass. (human and mouse). Moreover, non-recombinant IL-4 has been purified from various culture supernatants, e.g. Sanderson et al., Proc. Natl. Acad. Sci. USA, 83: 437-440 (1986)(mouse); Grabstein et al., J. Exp. Med., 163: 1405-1413 (1985)(mouse); Ohara et al., J. Immunol., 135: 2518-2523 (1985)(mouse BSF-1); Butler et al., J. Immunol., 133: 251-255 (1984)(human BCGF); and Farrar et al., J. Immunol., 131: 1838-1842 (1983)(mouse BCGF). The disclosures of all the above articles are incorporated herein by reference for their teachings of DNA and amino acid sequences and of methods of obtaining suitable IL-4 materials for use in the present invention.
Preferably, the IL-4 used in the present invention will be a human IL-4, and most preferably it will be the human version with the sequence described in Yokoto et al., Proc. Natl. Acad. Sci. USA, 83: 5894-5898 (1986) and PCT Patent Application No. 87/02990 published May 21, 1987 that is expressed in and isolated from E. coli (U.S. patent application Ser

REFERENCES:
Nimer et al., JAMA, 1988, vol. 260(22) pp. 3297-3300.
Malmendier et al. Atherosclerosis 73: 173-180 (1988).

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