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(12) United States Patent (10) Patent No.: US 6,699,656 B2 Gallo Et Al

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(12) United States Patent (10) Patent No.: US 6,699,656 B2 Gallo Et Al USOO6699656B2 (12) United States Patent (10) Patent No.: US 6,699,656 B2 Gallo et al. (45) Date of Patent: *Mar. 2, 2004 (54) TREATMENT AND PREVENTION OF HIV 5,451.527 9/1995 Sarin et al. INFECTION BY ADMINISTRATION OF 5,494,899 2/1996 Kincade et al. DERVATIVES OF HUMAN CHORONIC 5,508.261 4/1996 Moyle et al. GONADOTROPIN 5,610,136 3/1997 McMichael 5,614.612 3/1997 Hagiwood et al. 5,635,599 6/1997 Pastan et al. (75) Inventors: Robert C. Gallo, Bethesda, MD (US); 5,650,390 7/1997 Samaritani et al. ......... 244/575 Joseph Bryant, Rockville, MD (US); 5,674,983 10/1997 Blithe et al. .................. 448/79 Yanto Lunardi-Iskandar, Gaithersburg, 5,677.275 10/1997 Lunardi-Iskandar et al. MD (US) 5,700,781 12/1997 Harris 5,811,390 9/1998 Bourinbaiar (73) Assignee: University of Maryland Biotechnology 5,817,753 10/1998 Stevens ...................... 958/601 Institute, Baltimore, MD (US) 5,877,148 3/1999 Lunardi-Iskandar et al. ... 514/8 5,968,513 10/1999 Gallo et al. (*) Notice: Subject to any disclaimer, the term of this 5.997,871 12/1999 Gallo et al. patent is extended or adjusted under 35 6,319,504 B1 11/2001 Gallo et al. U.S.C. 154(b) by 0 days. FOREIGN PATENT DOCUMENTS EP O O49898 B2 4/1982 This patent is Subject to a terminal dis EP O 142387 A1 5/1985 claimer. EP O 211 411 A2 2/1987 EP O323769 11/1988 - - - - - - - - - - - - - - - - - - - - - - - - 7/6 EP O211013 B1 3/1993 (21) Appl. No.: 10/050,875 JP O430O896 10/1992 (22) Filed: Nov. 20, 2001 WO WO 86/04241 7/1986 WO WO87/03487 6/1987 (65) Prior Publication Data WO WO 90/02759 3/1990 WO WO 90/07119 6/1990 US 2003/0049273 A1 Mar. 13, 2003 WO WO9108228 6/1991 WO WO 91/O9872 7/1991 Related U.S. Application Data WO WO 91/16921 11/1991 WO WO91/16921 11/1991 (60) Division of application No. 08/709,948, filed on Sep. 9, WO WO 92/0618O 4/1992 1996, now Pat. No. 6,319,504, which is a continuation-in WO WO92/12178 7/1992 part of application No. 08/669,681, filed on Jun. 24, 1996, now abandoned. (List continued on next page.) (51) Int. Cl. .................................................. C12O 1/70 OTHER PUBLICATIONS (52) U.S. Cl. ........................... 435/5; 435/7.1; 435/7.92; 435/7.94; 435/7.95; 435/974; 530/325; Aizawa and Tavassoli, 1986, Int. J. Cell Cloning 530/326; 530/327; 530/350; 424/195.11; 4:464-471. 424/1841; 424/198.1 (List continued on next page.) (58) Field of Search ............................ 435/5, 7.1, 7.92, 435/7.93, 7.94, 7.95, 974; 530/325, 326, Primary Examiner Jeffrey Stucker 327, 350; 424/198.1, 1841, 195.11 (74) Attorney, Agent, or Firm Marianne Fuierer; Steven J. Hultquist (56) References Cited (57) ABSTRACT U.S. PATENT DOCUMENTS The present invention relates to B-hCG, particularly 3-hCG 4,123,343 A 10/1978 Krupey et al. .............. 806/562 proteins having a sequence of amino acids 41-54, 45-54, 4,161,519 A 7/1979 Talwar 47-53, 45-57 and 45-58 and analogs and derivatives 4,201,770 A 5/1980 Stevens ...................... 424/177 thereof. The invention further relates to methods of treat 4,400,316 A 8/1983 Katsuragi et al. ment and prevention of HIV infection by administration of 4,665,161 A 5/1987 Yuki et al. .................. 857/511 a therapeutic compound of the invention. Such therapeutic 4,689.222 A 8/1987 McMichael 4,691,006 A 9/1987 Stevens compounds include hCG, B-hCG and B-hCG peptides, ana 4,692,332 A 9/1987 McMichael logs and derivatives of hCG, B-hCG and B-hCG peptides, 4,713,366 A 12/1987 Stevens and nucleic acids encoding hCG, 3-hCG and B-hCG pep 4,714,680 A 12/1987 Civin et al. tides. In a preferred embodiment, B-hCG peptides, particu 4,762.913 A 8/1988 Stevens larly B-hCG peptides of amino acids 47-53, 45-57 or 45-58 4,767,842 A 8/1988 Stevens are administered to a Subject for treatment or prevention of 4,780,312 A 10/1988 Talwar HIV infection in that subject. The invention also provides 4,855.285 A 8/1989 Stevens methods for Screening hCG preparations for activity in 4,880,626 A 11/1989 McMichael treating or preventing HIV infection. Pharmaceutical com 5,004,681 A 4/1991 Boyse ........................... 435/2 5,140,100 A 8/1992 Braunstein et al. ......... 639/249 positions and methods of administration of Therapeutics are 5,192,553 A 3/1993 Boyse et al. also provided. 5,380,668 A 1/1995 Herron 5,445,968 A 8/1995 Blithe et al. ................ 436/510 5 Claims, 17 Drawing Sheets US 6,699.656 B2 Page 2 FOREIGN PATENT DOCUMENTS Ferrero et al., 1983, Proc Natl. Acad. Sci. USA 80:4114*. WO WO9222568 12/1992 Ferrero et al., 1986, Cancer Res. 46:975-980*. WO WO 92/22654 12/1992 Franks et al., 1995, Pediatric Res. 37:56–63. WO WO93/11788 6/1993 Friedman-Kien et al., 1981, J. Am. Acad. Dermatol. WO WO 93/14188 7/1993 5:468-473. WO WO 93/20221 10/1993 Gallo et al., 1984, Science 224:500–503. WO WO 94/20859 9/1994 Geller et al., 1985, Archs. Path. Lab. Met. 109:138-145. WO WO 94/24148 10/1994 Gelmann et al., 1987, Am. J. Med. 82:456-462*. WO WO 96/04008 2/1996 Gill et al., 1990, Am. J. Clin. Oncol. 13:315-319. 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