Orally-administered interferon-TAU compositions and methods

Details Orally-administered interferon-TAU compositions and methods Orally-administered interferon-TAU compositions and methods

1996-03-15

2002-04-16

Bui, Phuong T (Department: 1638)

Drug, bio-affecting and body treating compositions

Lymphokine

Interferon

C930S142000, C435S069510, C536S023520, C530S324000, C530S351000

Reexamination Certificate

active

06372206

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to orally-administered pharmaceutical compositions containing interferon-tau and methods of uses thereof.
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B
ACKGROUND OF THE
I
NVENTION
Conceptus membranes, or trophectoderm, of various mammals produce biochemical signals that allow for the establishment and maintenance of pregnancy (Bazer, et al., 1983). One such protein, ovine trophoblast protein-one (oTP-1), was identified as a low molecular weight protein secreted by sheep conceptuses between days 10 and 21 of pregnancy (Wilson, et al., 1979; Bazer, et al., 1986). The protein oTP-1 was shown to inhibit uterine secretion of prostaglandin F
2
-alpha, which causes the corpus luteum on the ovary to undergo physiological and endocrinological demise in nonpregnant sheep (Bazer, et al., 1986). Accordingly, oTP-1 has antiluteolytic biological activity. The primary role of oTP-1 was assumed to be associated with the establishment of pregnancy. oTP-1 was subsequently found to (i) exhibit limited homology (50-70%) with interferon alphas (IFN&agr;) of various species (Imakawa, et al., 1987), and (ii) bind to a Type I interferon receptor (Stewart, et al., 1987). Despite some similarities with IFN&agr;, oTP-1 has several features that distinguish it from IFN&agr; including the following: oTP-1's role in reproductive biochemistry (other interferons are not known to have any role in the biochemical regulation of reproductive cycles), oTP-1's cellular source—trophoblast cells (IFN&agr; is derived from lymphocyte cells), oTP-1's size—172 amino acids (IFN&agr; is typically about 166 amino acids), and oTP-1 is weakly inducible by viruses (IFN&agr; is highly inducible by viruses). The International Interferon Society recognizes oTP-1 as belonging to an entirely new class of interferons which have been named interferon-tau (IFN&tgr;). The Greek letter &tgr; stands for trophoblast.
The interferons have been classified into two distinct groups: type I interferons, including IFN&agr;, IFN&bgr;, and IFN&ohgr; (also known as IFN&agr;II); and type II interferons, represented by IFN&ggr; (reviewed by DeMaeyer, et al., 1988). In humans, it is estimated that there are at least 17 IFN&agr; non-allelic genes, at least about 2 or 3 IFN&bgr; non-allelic genes, and a single IFN&ggr; gene.
IFN&agr;'s have been shown to inhibit various types of cellular proliferation. IFN&agr;'s are especially useful against hematologic malignancies such as hairy-cell leukemia (Quesada, et al., 1984). Further, these proteins have also shown activity against multiple myeloma, chronic lymphocytic leukemia, low-grade lymphoma, Kaposi's sarcoma, chronic myelogenous leukemia, renal-cell carcinoma, urinary bladder tumors and ovarian cancers (Bonnem, et al., 1984; Oldham, 1985). The role of interferons and interferon receptors in the pathogenesis of certain autoimmune and inflammatory diseases has also been investigated (Benoit, et al., 1993).
IFN&agr;'s are also useful against various types of viral infections (Finter, et al., 1991). Alpha interferons have shown activity against human papillomavirus infection, Hepatitis B, and Hepatitis C infections (Finter, et al., 1991; Kashima, et al., 1988; Dusheiko, et al., 1986; Davis, et al., 1989).
In addition, type I interferons are useful in treating autoimmune diseases such

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