Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Phosphorus containing other than solely as part of an...
Patent
1996-08-15
1999-05-04
Goldberg, Jerome D.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Phosphorus containing other than solely as part of an...
A61K 3166
Patent
active
059004118
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a novel method for prophylaxis and for the treatment of Kaposi's sarcoma.
DEFINITIONS
The term "foscarnet" herein denotes phosphonoformic acid or physiologically acceptable salts thereof, for example FOSCAVIR.RTM., the trade name for foscarnet sodium, which is trisodium phosphonoformate hexahydrate.
Dose figures given as mg/kg/day are to be interpreted as weight of active substance per body weight of the patient per day.
BACKGROUND OF THE INVENTION
There are four different types of Kaposi's sarcoma (KS): Classic KS, endemic African KS, KS associated with immunosuppressive therapy, and epidemic/HIV-AIDS related KS.
KS is the most common AIDS-related neoplasia and contributes to morbidity and mortality in AIDS patients. The majority of cases of epidemic KS is seen in homosexual males with immunodeficiency of clinical significance. KS is currently afflicting approximately 20 000 AIDS patients annually in the United States (AIDS Weekly, Sep. 12, 1994). Up to 40 per cent of homosexual men with AIDS eventually develop KS.
The cause of KS is not yet known. Epidemiological studies indicate that a sexually transmissible agent is a factor of pathogenetic importance (Beral, V. et al: Kaposi's sarcoma among persons with AIDS: a sexually transmitted infection?, Lancet 335: 123-128, 1990, and Elford, J. et al: Kaposi's sarcoma as a sexually transmissible infection: an analysis of Australian AIDS surveillance data. AIDS 7: 1667-1671, 1993).
KS appears as reddish or purple lesions preferentially on the skin and mucous membranes of he gastrointestinal tract. About 50 per cent of cases exhibit lesions in the mouth. In advanced cases of KS lymph nodes and parenchymatous organs such as lungs and liver are frequently involved.
The KS lesions are often the only visible sign of AIDS and lead to severe psycho-social problems for the patient. During the course of KS the cutaneous lesions may become painful and secondary oedema from lymph node involvement may cause grotesque swelling of different parts of the body. Bleedings or obstruction of the gastrointestinal tract or the lungs occurs in advanced cases of KS.
Characteristic histopathological features of KS tumors include interweaving bands of "spindle cells" and vascular structures embedded in a network of collagen and reticular fibers. The presence of extravasated blood cells and hemosiderin is also characteristic. Whether or not KS is a true malignancy or merely a hyperplasia of certain tissues has been debated for quite some time. The isolation of KS cells from a patient exhibiting all the characteristics of a true malignancy has now been reported. At the same time it was claimed that a transmissible agent is not necessary for the pathogenesis of KS (Gallo, R. C. at The International Conference on AIDS in Yokohama, August, 1994).
Spindle cells characteristic of KS have been isolated from blood of HIV-infected patients with KS and, remarkedly, spindle cells have been isolated from a substantial proportion of HIV-infected homosexual men without any signs of KS (Gallo, R. C., ibid.). It might, therefore, be that KS can be diagnosed by the detection of markers in blood or secretions before visible lesions of KS appear in patients.
At present, there is no cure for KS or the immunodeficiency of HIV infection. The patients suffering from KS are currently offered chemotherapy, interferons, irradiation or different kinds of local treatment for palliation. Short remission and considerable side-effects limit the benefit of these therapeutic regimens. Continuous therapy is most often needed. Hair loss, nausea, vomiting, granulocytopenia with risk for bacterial infections, peripheral neuropathies and pulmonary problems are negative side-effects which significantly impair the quality of life of the patient.
Several studies have failed to show any significant anti-KS effect attributable to zidovudine, commonly known as AZT, which is an antiviral drug widely used against HIV-infection (Lane, HC et al.: Zidovudine in Patients wit
Astra Akiebolag
Goldberg Jerome D.
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