Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1987-07-24
1990-05-01
Stone, Jacqueline M.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
514 8, 514 44, 514 50, 514885, A61K 3702
Patent
active
049218379
DESCRIPTION:
BRIEF SUMMARY
Acquired Immune Deficiency Syndrome, commonly known as AIDS, is a generally lethal disease of increasing notoriety. A less malignant form called AIDS-Related Complex (referred to as ARC) is also increasing in prevalence. For purposes of this invention these and related maladies may be hereinafter referred to generically as AIDS-type disease.
AIDS-type disease affects humans and other primates and is characterized by a general loss of the host immune response to invading pathogens. Another characteristic is pancytopenia, i.e. a marked depression in the hematological profile of the host. The etiologic agent is believed to be viral, and more specifically, retroviruses of the HTLV/LAV-type, now known as the human immunodeficiency virus (HIV). Related viruses with similar pathogenicity are found in monkeys and other simians. Despite various reports of successful treatments with diverse agents, there is still much need for effective therapy of AIDS-type disease.
According to my invention one or more primate colony stimulating factors are used to treat patients suffering from AIDS-type disease. The beneficial effects of this treatment can be measured by improved hematological profile (e.g. the reduction of cytopenia) and restoration of immune function.
Colony stimulating factors (CSFs) are a recognized class of proteins whose natural counterparts are produced in very low concentrations in the body. They stimulate the growth and development of various bone marrow progenitor cells into mature cells such as granulocytes, macrophages, megakaryocytes, erythrocytes, lymphocytes and mast cells. They obtain their name from the in vitro assay which measures the stimulation of colony formation by bone marrow cells plated in semi-solid culture media. These factors induce the formation of such colonies. Stated another way, CSFs are factors required for survival, proliferation and differentiation of the myeloid, lymphoid and erythroid progenitors.
A leading and preferred example of such a colony stimulating factor for use in this invention is GM-CSF, also known as granulocyte-macrophage colony stimulating factor It is described in detail in Wong et al Science Vol. 228, pp, 810-815 (May 17, 1985) and references cited therein. Wong et al. also teach its production via recombinant DNA techniques. While GM-CSF had been recognized as exhibiting significant in vitro activity on the various hematopoietic progenitor cells, its use in treatment of clinical conditions has been conjectural.
Another example of such colony stimulating factor is primate G-CSF, also known as beta-CSF or granulocyte-CSF. This factor produces colonies which contain primarily granulocytes and has been recently cloned. See Nagata et al., Nature, 319:415-418 (1986) and Souza et al. Science, 232:61-65, (1986).
Another colony stimulating factor for use in the treatment of this invention is primate IL-3, also known as pluripotent or multi-CSF. This CSF acts in an earlier stage in hematopoiesis. It has been described in Yang et al., Cell, 42:3-10, (1986).
Still another CSF within the scope of this invention is M-CSF, also known as CSF-1 or CSF-69. It produces colonies which contain primarily macrophages. It has been described in Kawasaki et al., Science, 230:291-296 (1985) and publications by E. R. Stanley. Its production by recombinant DNA techniques is described in U.S application Ser. No. 860,377. A truncated version is described in PCT/US86/00238.
Yet a further example of a CSF of this invention is CSF-309. This CSF acts in the early stages of hematopoiesis. It is described in U.S. CIP application Ser. No. 885,905 and Hirano et al, Nature, 324:73-76 (Nov. 6, 1986).
The CSFs can be systemically administered either intravenously or subcutaneously. One preferred form is via a subcutaneous implant, e.g., an osmotic continuous infusion pump. Numerous said implants are known in the art. The dosage regimen will be determined by the attending physician considering the condition of the patient, the severity of any infection and other clinical factors. Generally, the regi
REFERENCES:
patent: 4230697 (1980-10-01), Nishida et al.
Mitsuya et al, cited in Chem. Abstracts, vol. 103:189277e, 1985.
Rook et al, J. Immunol., vol. 134, No. 3, 1985.
Kern et al, cited in Biol. Abstracts, vol. 79(11), No. 100547, 1985.
Motoyoshi et al, cited in Chem. Abstracts, vol. 99:1046a, 1982.
Metcalf et al, cited in Chem. Abstracts, vol. 91:49943e, 1979.
Spivak et al, cited in Biol. Abstracts, vol. 78(12), No. 92073, 1984.
Umemura, et al., Clinical Research 36(3): 570A (Abstract).
McDonagh, et al., Clinical Research 36(3):414A (Abstract).
Donahue, et al., Nature 321:872-875 (Jun. 1986).
Metcalf, et al, Exp Hematol. 15:1-9 (1987).
Tomonaga, et al., Blood 67:31-36 (Jan. 1986).
Emerson, et al., J. Clin. Invest. 76:1286-1290 (Sep. 1985).
Donahue, et al., Blood 66:1479-1481 (Dec. 1985).
Sieff, et al., Science 230:1171-1173 (Dec. 1985).
Donahue, et al., Nature 326:200-203 (Mar. 1987).
Yarchoan, et al., The Lancet, Mar. 15, 1986, pp. 575-580.
Sommadossi, et al., Antimicrobial Agents and Chemotherapy, 31:452-454 (Mar. 1987).
Johnson, et al., British Journal of Hematology 70:137-141 (1988).
Yarchoan, et al., Scientific American 259:110-119 (Oct. 1988).
Dagani, Chemical & Engineering News, Jun. 29, 1987, pp. 25-27.
"GM-CSF, Potential Therapy, May Assist AIDS Virus in Some Cases, Group Reports," Wall Street Journal, Sep. 23, 1988, p. 24.
Koyonagi, et al., Science 241:1673-1675, Sep. 1988.
Groopman, et al, N. Eng. J. Med. 317:593-598, Sep. 1987.
Perno, et al., "Replication of Human Immunodeficiency Virus in Monocytes," The Journal of Experimental Medicine 169:933-951, Mar. 1989.
"Companies Push Development of More Lymphokines" Genetic Technology News (Dec. 1984) p. 5.
"GM-CSF to be Used in AIDS Therapy" Applied Genetic News 7:7-8, (1986).
Cetus Corporation Annual Report 1985 (Sep. 1985).
Cserr Luann
Eisen Bruce M.
Genetics Institute Inc.
O'Shaughnessy Brian P.
Stone Jacqueline M.
LandOfFree
Treatment of AIDS-type disease does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Treatment of AIDS-type disease, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Treatment of AIDS-type disease will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-829634