« AnteriorContinuar »
(12) United States Patent ao) Patent No.: us 6,552,006 B2
Raz et al. (45) Date of Patent: Apr. 22,2003
POLYNUCLEOTIDES IN TREATMENT OF
AN INFECTION BY AN INTRACELLULAR
(75) Inventors: Eyal Raz, Del Mar, CA (US); Richard
Kornbluth, La Jolla, CA (US); Antonio
Catanzaro, San Diego, CA (US);
Tomoko Hayashi, San Diego, CA (US);
Dennis Carson, Del Mar, CA (US)
(73) Assignees: The Regents of the University of California, Oakland, CA (US); The United States of America as represented by the Department of Veteran Affairs, Washington, DC (US)
( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 32 days.
(21) Appl. No.: 09/774,403
(22) Filed: Jan. 30, 2001
(65) Prior Publication Data
US 2002/0086295 Al Jul. 4, 2002
Related U.S. Application Data
(60) Provisional application No. 60/179,353, filed on Jan. 31, 2000.
(51) Int. CI. A61P 37/06
(52) U.S. CI 514/44; 435/320.1; 536/23.1
Romano et al., Latest developments in gene transfer technology: Achievements, perspectives and controversies over therapeutic applications, 2000, Stem Cells, vol. 18, pp. 19-39.*
Krieg, Direct immunologic activities of CpG DNA and implications for gene therapy, 1999, The Journal of Gene Medicine, vol. 1, pp. 56-63.*
Tokunaga et al., How BCG to the discovery of immunostimulatory DNA, 1999, Japan J. Infect. Dis., vol. 52, pp. 1-11.*
Orkin et al., Report and recommendations of the panel to assess the NIH investment in research on gene therapy, 1995, NIH,pp. 1-33.*
Kmiec, Gene therapy, 1999, American Scientist, vol. 87, pp. 240-247.*
Appelberg et al. (1994) "Role of Gamma Inferferon and Tumor Necrosis Factor Alpha during T-Cell-Independent and -Dependent Phases of Mycobacterium avium Infection." Infection and Immunity, vol. 62(9):3962-3971. Autran et al. (1997) "Positive Effects of Combined Antiretroviral Therapy on CD4+ T Cell Homeostasis and Function in Advanced HIV Disease." Science, vol. 277:112-116. Bermudez et al. (1991) "Interaction of Mycobacterium avium Complex with Human Macrophages: Roles of Membrane Receptors and Serum Proteins." Infection and Immunity, vol. 59(5):1697-1702.
Bonato et al. (1998) "Identification and Characterization of Protective T Cells and hsp65 DNA-Vaccinated and Mycobacterium tuberculosis-Infected Mice." Infection and Immunity, vol. 66(1):169-175.
Chin et al. (1994) "The Impact of Mycobacterium avium Complex Bacteremia and Its Treatment on Survival of AIDS Patients—A Prospective Study." The Journal of Infectious Diseases, vol. 170:578-84.
Crowe et al. (1991) "Predictive Value of CD4 Lymphocyte Numbers for the Development of Opportunistic Infections and Malignancies in HIV-infected Persons." Journal of Acquired Immune Deficiency Syndromes, vol. 4:770-776. Doherty et al. (1997) "Defects in Cell-Mediated Immunity Affect Chronic, but Not Innate, Resistance of Mice to Mycobacterium avium Infection." Journal of Immunology, vol. 158:4822-4831.
Doherty et al. (1998) "IL-12 Promotes Drug-Induced Clearance of Mycobacterium avium Infection in Mice." Journal of Immunology, vol. 160:5428-5435.
(List continued on next page.)
Primary Examiner—James Ketter
Assistant Examiner—Daniel M. Sullivan
(74) Attorney, Agent, or Firm—Carol L. Francis; Paula A.
Borden; Bozicevic, Field & Francis, LLP
Edwards et al. (1986) "The Immunology ol Mycobacterial Diseases." Am. Rev. Respir. Dis., vol. 134:1062-1071. Faria et al. (2001) "Phosphoroamidate oligonucleotides as potent antisense molecules in cells and in vivo." Nature Biotechnology, vol. 19:40-44.
Fattorini et al. (1994) "Induction of IL-1|3, IL-6, TNF-a, GM-CSF and G-CSF in human macrophages by smooth transparent and smooth opaque colonial variants of Mycobacterium avium." J. Med. Microbiol, vol. 40:129-133. Halpern et al. (1996) "Bacterial DNA Induces Murine Interferon-y Production of Stimulation of Interleukin-12 and Tumor Necrosis Factor-a." Cellular Immunology, vol. 167:72-78.
Holland et al. (1994) "Treatment of Refractory Disseminated Nontuberculous Mycobacterial Infection with Interferon Gamma." The New England Journal of Medicine, vol. 330(19):1348-1355.
Horsburgh et al. (1991) "Mycobacterium Avium Complex Infection in the Acquired Immunodeficiency Syndrome." The New England Journal of Medicine, vol. 324(19):1332-1338.
Kamath et al. (1999) "Differential Protective Efficacy of DNA Vaccines Expressing Secreted Proteins of Mycobacterium tuberculosis." Infection and Immunity, vol. 67(4): 1702-1707.
Klinman et al. (1996) "CpG motifs present in bacterial DNA rapidly induce lymphocytes to secrete interleukin 6, interleukin 12, and interferon y." Proc. Natl. Acad. Sci. USA, vol. 93:2879-2883.
Klinman et al. (1999) "Repeated Administration of Synthetic Oligodeoxynucleotides Expressing CpG Motifs Provides Long-Term Protection against Bacterial Infection." Infection and Immunity, vol. 67(ll):5658-5663. Kobayashi et al. (1995) "Protection of Mice from Mycobacterium avium Infection by Recombinant Interleukin-12." Antimicrobial Agents and Chemotherapy, vol. 39(6):1369-1371.
Krieg et al. (1995) "CpG motifs in bacterial DNA trigger direct B-cell activation." Nature, vol. 374:546-549. Krieg et al. (1998) "CpG DNA Induces Sustained IL-12 Expression In Vivo and Resistance to Listeria monocytogenes Challenge." Journal of Immunology, vol. 161:2428-2434.
Martin-Orozco et al. (1999) "Enhancement of antigen-presenting cell surface molecules involved in cognate interactions by immunostimulatory DNA sequences." International Immunology, vol. 11(7): 111-1118.
Masur (1993) "Recommendations on Prophylaxis and Therapy for Disseminated Mycobacterium avium Complex Disease in Patients Infected with the Human Immunodeficiency Virus." New. Eng. J. Med, vol. 329:898-904.
Messina et al. (1991) "Stimulation of In Vitro Murine Lymphocyte Proliferation By Bacterial DNA." The Journal of Immunology, vol. 147(6):1759-1764. Newman et al. (1991) "Survival of Human Macrophages Infected with Mycobacterium avium intracellulare Correlates with Increased Production of Tumor Necrosis Factor-a and IL-6." The Journal of Immunology, vol. 147(ll):3942-3948.
Rao et al. (1993) "Mycobacterium avium—M. intracellulare Binds to the Integrin Receptor av(33 on Human Monocytes and Monocyte-Derived Macrophages." Infection and Immunity, vol. 61(2):663-670.
Roecklein et al. (1992) "Nonopsonic uptake of Mycobacterium avium complex by human monocytes and alveolar macrophages."/. Lab. Clin. Med., vol. 119:772-781. Roman et al. (1997) "Immunostimulatory DNA sequences functions T helper-l-promoting adjuvants." Nature Medicine, vol. 3(8):849-854.
Sparwasser et al. (1997) "Macrophages sense pathogens via DNA motifs: indujction of tumor necrosis factor-a-mediated shock." Eur. J. Immunol, vol. 27:1671-1679.
Sparwasser et al. (1998) "Bacterial DNA and immunostimulatory CpG oligonucleotides trigger maturation and activation of murine dendritic cells." Eur. J. Immunol, vol. 28:2045-2054.
Stacey et al. (1999) "Immunostimulatory DNA as an Adjuvant in Vaccination against Lieshmania major." Infection and Immunity, vol. 67(8):3719-3726. Stacey et al. (1996) "Macrophages Ingest and Are Activated by Bacterial DNA." /. Immunol, vol. 157:2116-2122. Toulme (2001) "New candidates for true antisense." Nature Biotechnology, vol. 19:17-18.
Velaz-Faircloth et al. (1999) "Protect against Mycobacterium avium by DNA Vaccines Expressing Mycobacterial Antigens as Fusion Proteins with Green Fluorescent Protein." Infection and Immunity, vol. 4243-4250. Walker et al. (1999) "Immunostimulatory oligodeoxynucleotides promote protective immunity and provide systemic therapy for leishmaniasis via IL-12- and IFN-y-dependent mechanism." Proc. Natl. Acad. Sci. USA, vol 96:6970-6975. Yamamoto et al. (1992) "DNA from Bacteria, but Not from Vertebrates, Induces Interferons, Activates Natural Killer Cells and Inhibits Tumor Growth." Microbiol. Immunol, vol. 36(9):983-997.
Zimmermann et al. (1998) "Cutting Edge: CpG Oligodeoxynucleotides Trigger Protective and Curative Thl Responses in Lethal Murine Leishmaniasis." The Journal of Immunology, vol. 160:3627-3630..
* cited by examiner