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(12) United States Patent (10) Patent No.: US 8,784,836 B2

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(12) United States Patent (10) Patent No.: US 8,784,836 B2 US008784836B2 (12) UnitedO States Patent (10) Patent No.: US 8,784,836 B2 Szalay et al. (45) Date of Patent: *Jul. 22, 2014 (54) MICROORGANISMS FORTHERAPY 5,221,623 A 6/1993 Legocki et al. ............ 435/252.3 5,283,187 A 2f1994 Aebischer et al. ... 435/182 (75) Inventors: Aladar A. Szalay, Highland, CA (US). 5,364,7735,300,436 A 1 4,1/1994 1994 PaolettiGoldstein et etal. al. ..... .. ... 435/69.1435/190 Tatyana Timiryasova, San Diego, CA 5,368,855. A 1 1/1994 Boyle et al. ................ 435/320.1 (US); Yong A. Yu, San Diego, CA (US); 5,378.457 A 1/1995 Paoletti et al. ............. 424/205.1 Qian Zhang, San Diego, CA (US) 5,494,807 A 2f1996 Paoletti .......... ... 435/69.3 5,550,050 A 8, 1996 Holland et al. ... 435/.382 (73) Assignee: Genelux Corporation, San Diego, CA 5,639,275 A 6/1997 Baetge et al. ...... 604/891.1 (US) 5,646.298 A 7/1997 Powell et al. ...... ... 548/427 5,650,135 A 7/1997 Contaget al. .. ... 424/9.1 - 5,650,148 A 7/1997 Gage et al. ..... ... 424/93.2 (*) Notice: Subject to any disclaimer, the term of this 5,653,975 A 8/1997 Baetge et al. .. ... 424,931 patent is extended or adjusted under 35 5,656,481 A 8/1997 Baetge et al. ...... 435/325 U.S.C. 154(b) by 0 days. 5,676,943 A 10/1997 Baetge et al. .. 424.93.21 5,693,533 A 12/1997 Raney et al. ... ... 435,366 This patent is Subject to a terminal dis- 5,704,910 A 1/1998 Humes ........ ... 604,502 claimer. 5,710,137 A 1/1998 Fisher ............................. 514,44 5,718,902 A 2f1998 Yilma et al. ... 424/211.1 (21) Appl. No.: 13/507,572 5,750,1037. A 5/199835 CherkSevkNE.I.". ....... ... 424/93.21 514/12 5,762.938 A 6/1998 Paoletti et al. ............. 424,199.1 (22) Filed: Jul. 10, 2012 5,762.959 A 6/1998 Soon-Shiong et al. ....... 424/451 5,795,790 A 8/1998 Schinstine et al. ..... ... 435/.382 (65) Prior Publication Data 5,798,113 A 8, 1998 Dionne et al. 424/422 5,800,828 A 9, 1998 Dionne et al. 424/422 US 2012/O276O1 O A1 Nov. 1, 2012 5,800,829 A 9, 1998 Dionne et al. ..... ... 424/422 5,830,702 A 1 1/1998 Portnoy et al. ... ... 435/69.3 5,833,975 A 11/1998 Paoletti et al. ..... ... 424/93.2 Related U.S. Application Data 5,833,979 A 11/1998 Schinstine et al. 424.93.21 5,834,001. A 1 1/1998 Dionne et al. ..... ... 424/422 (60) Continuation of application No. 12/589,694, filed on 5,837,234 A 11/1998 Gentile et al. ..... ... 424/93.7 Oct. 26, 2009, now Pat. No. 8,221,769, which is a 5,840,576 A 11/1998 Schinstine et al. 435/325 continuation of application No. 1 1/796,028, filed on 5,842,431 A 12/1998 Wu ............................... 112,232 Apr. 25, 2007, which is a division of application No. (Continued) 10/872,156, filed on Jun. 18, 2004, now Pat. No. 7,588,767. FOREIGN PATENT DOCUMENTS (30) Foreign Application Priority Data AU TO9336 4f1995 CA 2105.277 12/2006 Jun. 18, 2003 (EP) ..................................... O3O13826 (Continued) Aug. 14, 2003 (EP) ..................................... O3O18478 Oct. 22, 2003 (EP) ..................................... O3O24283 OTHER PUBLICATIONS (51) Int. Cl. Neubauer et al., Specific detection of monkeypox virus by AOIN 63/00 (2006.01) polymerase chain reaction, 1998, Journal of Virological Methods, A6 IK 39/2 (2006.01) vol. 74, pp. 201-207.* A 6LX39/275 (2006.01) A6 IK39/00 (2006.01) (Continued) GOIN33/574 (2006.01) A61 K39/145 (2006.01) (52) U.S. Cl. Primary Examiner — Benjamin P Blumel USPC .................. 424/199.1; 424/232.1; 424/205.1; (74) Attorney, Agent, or Firm — McKenna Long & Alridge 424/93.3; 424/277.1 LLP; Stephanie Seidman (58) Field of Classification Search None See application file for complete search history. (57) ABSTRACT (56) References Cited Therapeutic methods and vaccinia virus therefor are pro vided. The viruses are designed so that they accumulate in U.S. PATENT DOCUMENTS immunoprivileged tissues and cells, such as in tumors and 4,216,226 A 8/1980 Fukuyasu et al. ............. 514,546 other proliferating tissue and in inflamed tissues, compared to 4,315,914 A 2, 1982 Arakawa et al. ... 424,281.1 other tissues, cells and organs, so that they exhibit relatively 4,442,203 A 4, 1984 Varshavsky ....................... 435/6 low toxicity to host organisms. Combinations of the viruses 4,603,112 A 7, 1986 Paoletti et al. ... ... 435/235.1 and anti-cancer agents and uses thereof for treating cancer 4,722,848 A 2f1988 Paoletti et al. ... ... 424,199.1 4,769,330 A 9, 1988 Paoletti et al. ................ 435,436 also are provided. 4,778,759 A 10/1988 Szalay et al. .................. 435/477 5,110,587 A 5, 1992 Paoletti et al. ... ... 435/235.1 5,155,020 A 10, 1992 Paoletti ........................ 435/69.1 19 Claims, 2 Drawing Sheets US 8,784,836 B2 Page 2 (56) References Cited 2003. O133949 A1 7/2003 Szalay et al. ............... 424, 2001 2003. O161788 A1 8/2003 Zhao et al. ..................... 424/9.6 U.S. PATENT DOCUMENTS 2003. O165465 A1 9, 2003 Roberts et al. .. ... 424/93.2 2003/O165477 A1 9/2003 Balloul et al. ............. 424.93.21 5,853.385 A 12, 1998 Emerich et al. ............... 604,500 2003/0.198.627 A1 10, 2003 Arts et al. .................. 424.93.21 5,853,717. A 12/1998 Schinstine et al. ......... 424/93.21 2003/0213007 A1 1 1/2003 Slattery et al. .................. 800, 15 5,861,290 A 1/1999 Goldsmith et al. ........... 435/456 2003/0228261 Al 12/2003 Szalay et al. ... ... 424/9.34 5,866,131 A 2, 1999 Ramshaw et al. .......... 424,186.1 2003/0228330 A1 12/2003 Falkner et al. .. 424,232.1 5,976,796 A 11/1999 Szalay et al. ...................... 435/6 2004/0076622 A1 4/2004 Studeny et al. ... 424/93.21 6,007,806 A 12/1999 Lathe et al. .... 424.93.2 2004/009 1995 A1 5, 2004 Schlom et al. .. 435/235.1 6,025,155 A 2/2000 Hadlaczky et al. ... 435/69.1 2004.0143861 A1 7/2004 Hadlaczky et al. ............. 800, 14 6,045,802 A 4/2000 Schlom et al. ..... 424,199.1 2004/0213741 A1 10/2004 Szalay et al. ... 424/9.6 6,077,697 A 6/2000 Hadlaczky et al. 435/1723 2004/0234455 A1 1 1/2004 Szalay et al. ................... 424/9.6 6,080,849 A 6/2000 Bermudes et al. .... 536,23.7 2005/0O257.45 A1 2/2005 Fujimori et al. ............. 424.93.2 6,093,700 A 7/2000 Mastrangelo et al. ... 514/44 2005/0O25747 A1 2/2005 Laidlaw et al. ... 424/93.2 6,099,848 A 8/2000 Frankel et al. ............. 424,246.1 2005, OO31643 A1 2/2005 Szalay et al. ... 424,199.1 6,106,826 A 8/2000 Brandt et al. ................ 424.93.2 2005, OO63993 A1 3/2005 Schlom et al. 424,199.1 6, 190,657 B1 2/2001 Pawelek et al. 424,931 2005, OO69491 A1 3, 2005 Yu et al. ... ... 424/1.11 6,217,847 B1 4/2001 Contag et al. ... 424/9.1 2005/0249670 A1 1 1/2005 Szalay et al. ... 424/9.32 6,232,523 B1 5, 2001 Tan et al. .... ... 800/10 2006, OOO4191 A1 1/2006 Jhiang et al. 536,235 6,235,967 B1 5, 2001 Tan et al. ... 800/10 2006/0051370 A1 3/2006 Szalay et al. 424,199.1 6,235,968 B1 5, 2001 Tan et al. ... 800/10 2006.0099224 A1 5, 2006 Kirn ......... ... 424,199.1 6,251,384 B1 6/2001 Tan et al. .... 424/93.21 2006/0134801 A1 6/2006 Chada et al. ... 436,177 6,265,189 B1 7/2001 Paoletti et al. 435/70.1 2006, O193832 A1 8/2006 Domann et al. ................ 514,44 6,265,557 B1 7/2001 Diamond et al. .. ... 536,23.1 2007/0O25981 A1 2/2007 Szalay et al. ... 424,130.1 6,416,754 B1 7/2002 Brown et al. .............. 424.93.21 2007, OO86984 A1 4/2007 Coffey et al. ... 424/93.2 6,428,968 B1 8/2002 Molnar-Kimber et al. .. 435/7.23 2007/0202572 A1 8/2007 Szalay et al. ... 435/69.1 6,448,073 B1 9/2002 Jager et al. ................. 435/320.1 2007/0212727 A1 9/2007 Szalay et al. ...................... 435/6 6,455,673 B1 9/2002 Collier .......................... 530/350 2008/O193373 A1 8, 2008 Stritzker et al. ... 424/1.17 6,491.905 B1 12/2002 Sorscher et al. .............. 435/325 2008, 0226674 A1 9, 2008 Kotani et al. ... 424,207.1 6,503,703 B1 1/2003 Palese et al. ...................... 435.5 2009.0053244 A1 2/2009 Chen et al. ... ... 424,174.1 6,511,967 B1 1/2003 Weissleder et al. ... 514/44 2009,0081639 A1 3, 2009 Hill et al. ..... 435/5 6,537,594 B1 3/2003 Paoletti et al. ..... 424.93.2 2009/0098529 A1 4, 2009 Chen et al. ... 435/5 6,548,068 B1 4/2003 Schlom et al. ............. 424,199.1 2009.0117034 A1 5/2009 Chen et al. ... 424,117 6,589,531 B1 7/2003 Andino-Pavlovsky 2009/01 17047 A1 5/2009 Szalay et al.
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