Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1998-11-19
2001-02-27
Low, Christopher S. F. (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C424S085400, C424S185100, C435S069500, C530S351000
Reexamination Certificate
active
06194381
ABSTRACT:
Therapeutic agent and method for feline AIDS virus infections and feline atopic dermatitis.
1. Technical Field
The present invention relates to a therapeutic agent and method for feline AIDS virus (FIV) infections and feline atopic dermatitis. A FIV belongs to Lentiviridae of Retroviridae, and cats living freely outdoors are often infected with it.
FIV infections are said to undergo three stages; an initial acute stage of virus infection, latent stage, and lastly, a chronic disease stage of immunodeficiency.
In the initial stage of infection, fever and lethargy can be observed, and lymphopenia and neutropenia occur. The skin and digestive tracts can become infected with microbes, but these are secondary infections by neutropenia. Vomition and anemia can also be observed. After the symptoms in the acute stage vanish, the latent stage continues for several months to several years.
In the last stage, chronic diseases such as chronic stomatitis, chronic respiratory organ diseases, anemia, intractable secondary infections and enteritis occur, and the carriers become gradually weak in several years, and finally die. Furthermore, opportunistic infections such as Haemobartonella diseases and Cryptococcus diseases can be seen.
2. Background of the Related Art
Therapy of FIV infections is still untapped, and no therapeutic method has been developed for eliminating FIV, i.e., a retrovirus from the feline body after infection. As therapeutic agents for human AIDS are developed, it can be considered to use them as anti-FIV drugs for cats in the future, but the application of a reverse transcriptase inhibitor such as AZT (azidothymidine) seems problematic for the time being, considering its side effects versus the desired effect to be achieved.
At present, therapeutic methods for symptoms from secondary infections, such as the administration of antibiotics, infusion and blood infusion and administration of steroid hormone preparations are used.
Anemia as one of FIV infections can be seen in the early stage and last stage of FIV virus infection, and at the onset, vitality vanishes and appetite diminishes or is lost. Furthermore, erythroid values such as erythrocyte number, hemoglobin and hematocrit decrease. Symptomatic therapeutic methods such as the administration of erythropoietin and the infusion of vitamins, amino acids, etc., and as the case may be, blood infusion are used. However, most carriers die, though these methods have some macrobiotic effect.
Chronic stomatitis as one of FIV infections is an intractable disease, and the inflammation of the gum near the roots of molar teeth causes heavy swelling, not allowing eating. Weakened cats in this stage come to hospital. Steroid hormone preparations such as Depo-Metrol are administered to temporarily improve the inflammation as a symptomatic therapeutic method. However, the disease recurs in 2 to 3 weeks, and the administration of steroid hormone preparations is practiced again. The recurrence period becomes gradually shorter, and partly because of side effects by steroid hormone preparations, the cats ultimately die.
As a feline interferon, a recombinant &ohgr;-interferon preparation is already approved as a therapeutic agent for calicivirus infections, and is marketed under a trade name of “INTERCAT” since Feb., 1994. The inventors studied a therapeutic method for FIV infections using this recombinant &ohgr;-interferon, and as a result, completed the present invention.
Presently known interferons include alpha (&agr;) interferons, beta (&bgr;) interferon, gamma (&ggr;) interferon, omega (&ohgr;) interferon and tau (&tgr;) interferon. As human interferons, three types of &agr;, &bgr; and &ggr; are practically applied, and as a feline interferon, an &ohgr;-interferon only is practically applied. “INTERCAT” is a recombinant &ohgr;-feline interferon preparation, and it is an injection preparation obtained by infecting
Bombyx mori
with a baculovirus recombined with the gene of an
107
-feline interferon, producing the interferon in the
Bombyx mori,
extracting and purifying it, adding gelatin and D-sorbitol as a stabilizer and recipient, and freeze-drying the mixture. The recombinant &ohgr;-feline interferon is a glycoprotein with a molecular weight of about 25,000, and its protein portion has the amino acid sequence as shown in SEQ ID NO:1 of the sequence listing.
The &ohgr;-feline interferon can also be produced by other methods than the
Bombyx mori
method. For example, it can be produced by transient expression methods using animal cells such as simian COS cells and gene recombination techniques using Chinese hamster ovary (CHO) cells, Escherichia coli, yeast, transgenic animals, etc.
As for the usage and dose of “INTERCAT” approved as a therapeutic agent for calicivirus infections, it is specified to administer 2.5~5 MU/kg of feline interferon intravenously three times every other day. In this case, MU (mega unit) is a method for expressing a titer with the antiviral activity of an interferon as an indicator, and expresses one million units. The inventors attempted to treat FIV infections, particularly anemia and chronic stomatitis, according to the same usage and dose of every-other-day administration as approved for treating calicivirus infections, but the expected effects could not be obtained. So, the inventors continued their studies by changing the usage and dose.
A task of the present invention is to provide a new excellent therapeutic agent and method for FIV infections.
On the other hand, for feline atopic dermatitis, there is no satisfactory therapeutic method even for human atopic dermatitis. Symptomatic therapeutic methods using steroid hormone preparations are frequently adopted. Steroid hormone preparations have side effects, and the symptomatic therapeutic methods are insufficient in therapeutic effect. Feline atopic dermatitis is an intractable disease. Generally observed feline allergic dermatitis is mostly atopic dermatitis including miliary eczema relating to parasites (such as fleas) and eosinophilic granuloma syndrome. Hitherto, drugs such as prednisolone and amcinolone are said to be effective, and they tend to be used more frequently. However, these drugs have the problem of side effects.
It was reported in an American medical magazine in 1990 (M. Boouniewwicz et al., American J. Medicine, 8.8, 365-370 (1990)) that a human &ggr;(gamma) interferon is effective for human atopic dermatitis.
However, this method is not sufficient in the effect of treating feline atopic dermatitis since human interferons are different in their action than feline interferons.
Another object of the present invention is to provide a new excellent therapeutic agent and method for feline atopic dermatitis.
Disclosure of the Invention
The inventors studied to achieve the above objectives, and as a result, found a therapeutic method for FIV infections by injecting a therapeutic agent containing a feline &ohgr;-interferon into cats.
An effective therapeutic method has been invented, in which the anemia and chronic stomatitis caused by infection with a FIV (confirmed to be positive in anti-FIV antibody by virus tests of feline blood) are treated by using a therapeutic agent containing a feline &ohgr;-interferon.
Furthermore, it has been found that a therapeutic agent containing an (&ohgr;-feline interferon is a new excellent therapeutic agent for feline atopic dermatitis.
The following objectives of the present invention have been industrially advantageously achieved by the present invention with the following constitution:
[1] A therapeutic agent for FIV infections, comprising a feline interferon preparation containing a feline interferon as a principal agent.
[2] The therapeutic agent for FIV infections, wherein the feline interferon is a a feline &ohgr;-interferon.
[3] The therapeutic agent for feline AIDS virus infections, wherein the feline &ohgr;-interferon is a recombinant interferon.
[4] The therapeutic agent for FIV infections, wherein the feline &ohgr;-interferon is a glycosylated interf
Go Ryougai
Kajimoto Tsunesuke
Suzuki Makoto
Gupta Anish
Low Christopher S. F.
Miller Austin R.
Toray Industries Inc.
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