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(12) Patent Application Publication (10) Pub. No.: US 2010/0075914 A1 FLACK Et Al US 20100075914A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0075914 A1 FLACK et al. (43) Pub. Date: Mar. 25, 2010 (54) METHODS FORTREATING HERPES VIRUS Publication Classification INFECTIONS (51) Int. Cl. (75) Inventors: Mary R. FLACK, Ann Arbor, MI A63L/708 (2006.01) (US); Susan Marie CIOTTI, Ann A 6LX 3L/7072 (2006.01) Arbor, MI (US); Tarek A63/675 (2006.01) HAMOUDA, Milan, MI (US); A6II 3/55 (2006.01) Joyce A. SUTCLIFFE, West A6II 3/538 (2006.01) Newton, MA (US); James R. A63/496 (2006.01) Baker, JR. Ann Arbor, MI (US) A6II 3/52 (2006.01) A6II 3/53 (2006.01) Correspondence Address: A6II 3/34 (2006.01) FOLEY AND LARDNER LLP A6II 3/13 (2006.01) SUTESOO 3OOOK STREET NW (52) U.S. Cl. ............... 514/45; 514/50: 514/86; 514/220; WASHINGTON, DC 20007 (US) 514/230.5: 514/253.09: 514/263.38: 514/263.4: (73) Assignee: Nanobio Corporation 514/274: 514/471; 514/662 (21) Appl. No.: 12/425,984 (57) ABSTRACT (22) Filed: Apr. 17, 2009 The present invention relates to methods for treating, killing, Related U.S. Application Data and/or inhibiting the growth of Herpes viruses in human Subjects comprising topically administering to a human Sub (60) Provisional application No. 61/046.262, filed on Apr. ject in need thereofa nanoemulsion composition having anti 18, 2008. viral properties. Patent Application Publication Mar. 25, 2010 Sheet 1 of 30 US 2010/0075914 A1 Patent Application Publication Mar. 25, 2010 Sheet 2 of 30 US 2010/0075914 A1 NOILOE-|N|||-/\SH—JOTEC]OWNESTROWN CJELVEH1N/m[:]EdÅLOLOHd100-ENDI %09 %07 Patent Application Publication Mar. 25, 2010 Sheet 3 of 30 US 2010/0075914 A1 LOETOETSINENSSHSSV– 878,'50|-|| ETO!HEA [] OSTW H SLOS8S O % LOETETTSLil’’JOL\75)||1SEANILNEWSSESSW'?: LNEINSSESS\/ W78*50/-| [] OTW9700'0=dOZ H SLO39?, SO % Patent Application Publication Mar. 25, 2010 Sheet 4 of 30 US 2010/0075914 A1 EIN 0 EIN %, †7?un61– Patent Application Publication Mar. 25, 2010 Sheet 5 of 30 US 2010/0075914 A1 ( No.(%0,0)=0 (----(%0' (------ (QIV) Patent Application Publication Mar. 25, 2010 Sheet 6 of 30 US 2010/0075914 A1 ) HEIBW-NVTdVX?NISnLOB?gnSBHIAGCESSESSW(SAVCI)SÐNITVEHOLEWIL(NOILVT^dOd LLI)ETOIHBA OLNOSIHVdWOO(JOB SISÄTVNVETSVL BHIT Patent Application Publication Mar. 25, 2010 Sheet 7 of 30 US 2010/0075914 A1 MEIEW-Nvidwy!:)NISn(JOIVOILSEANIEHLAGGESSESSW(SAVCI)?NITVEHOLEWIL(NOLLVTIndOdLLI)ETOIHEAOLNOSIH\fdWOOHOBSISÄTVNVET8WLBHIT (?OL=N)L00-AN%9'0 Patent Application Publication Mar. 25, 2010 Sheet 8 of 30 US 2010/0075914 A1 Patent Application Publication Mar. 25, 2010 Sheet 9 of 30 US 2010/0075914 A1 |9.1°009’0|00"92" 6?un61– (sÁeq)fiulleeHogeu?Lu?uo?onpay! 00°0 Patent Application Publication Mar. 25, 2010 Sheet 10 of 30 US 2010/0075914 A1 OL?Inô|- Patent Application Publication Mar. 25, 2010 Sheet 11 of 30 US 2010/0075914 A1 v CN ve (e) (uoso firl)o affeaWW Patent Application Publication Mar. 25, 2010 Sheet 12 of 30 US 2010/0075914 A1 su?BJ?S |?un61– uleuysZ-ASHJoedÅ?oueue? Z-ASHs^ººol100-£IN v N via (urodo firl) effereny Patent Application Publication Mar. 25, 2010 Sheet 13 of 30 US 2010/0075914 A1 Au3A||30.leuued 89|-61 |-09 |0y= |-02: "0%9°0%), 0£?i 5 } 5 009 0099 0009 00sz? 000z& 00s?$ 000!-- Patent Application Publication Mar. 25, 2010 Sheet 14 of 30 US 2010/0075914 A1 |?un61– S?uuJep?dEu??00-EN40uo?eeuuued q?6||aelod-ssouo Kdoosouo?uu Patent Application Publication Mar. 25, 2010 Sheet 15 of 30 US 2010/0075914 A1 ?un61–| uomeneuadu?voo-anjosiunea 8’01.00-£IN%100100-8N%-1.00–8|N%9 o ld cy CN S. o o o anssleuuep ueuf Toda fri Patent Application Publication Mar. 25, 2010 Sheet 16 of 30 US 2010/0075914 A1 (squueppuesquuep?da)senss?paÁessy zuuoZZ'G:eeuwfiu?soqu??nO zuuo£'$:eeuwalpp?IN zuuoG’O:eeuwJauu] 'uo?eo||dde-?sodsunou?zzqe Patent Application Publication Mar. 25, 2010 Sheet 17 of 30 US 2010/0075914 A1 JojSunO??7Z?ep?Aouðuu?XIS 0dO?ouO??eu?uuu040p :u?uo?emqueouoO BHOOHENNI“ ERHOOETICICIIN·············· Åpn?Suo?snyg?C]Ieua?eT:/).?un61-I u?XISJÐAepeOueuunHu? ºlduues JæAepeoueuunH eIduuesu?XIS Patent Application Publication Mar. 25, 2010 Sheet 18 of 30 US 2010/0075914 A1 ?00 SunOH?zz?eu?XISS?uuJep?dEJÐAepeO ueuunHO?u?uo?sn???C]|eJe?eT:9||eun61– enSS) usIOdo fin Patent Application Publication Mar. 25, 2010 Sheet 21 of 30 US 2010/0075914 A1 ---uww.e------------w---wx-wi. sunou?zzsluuJep?dEu????M(OBO)uo|s|nuuÐOueN:LZ(61-) uO?eo||dde-?SOd --000|| |-006 -009 |-00/ |-009 -009 |-0037 ueuf I do fri Patent Application Publication Mar. 25, 2010 Sheet 23 of 30 US 2010/0075914 A1 gouo??eo||ddweuOauu?LjeZ00-EN%9Z"Osunou8pue0 000|| 008 009 007 OOZ ensSI) ufloo fri Patent Application Publication Mar. 25, 2010 Sheet 24 of 30 US 2010/0075914 A1 eeuw 009 enSS ufloo frt Patent Application Publication Mar. 25, 2010 Sheet 25 of 30 US 2010/0075914 A1 QX00-8 N BX00-£IN 0099 0009 000Z 000|| Patent Application Publication Mar. 25, 2010 Sheet 26 of 30 US 2010/0075914 A1 - O O CP : 2 : & O G U Z : : - O O O O O O X O L?) O CN CN wom war Patent Application Publication Mar. 25, 2010 Sheet 27 of 30 US 2010/0075914 A1 (O LO w CYX CN v- C Iufnd NINOILond '6o N. CO i? cy) (N v- C u/nd NINOILOnoda'6o Patent Application Publication Mar. 25, 2010 Sheet 28 of 30 US 2010/0075914 A1 Z?un61-I (91)?II ~~~~~â~~~~~~~~~“Tae”,”i”~~~~ anssue 3 / ZOA ari Patent Application Publication Mar. 25, 2010 Sheet 29 of 30 US 2010/0075914 A1 s D O O O O nSSIWWIZOW6 Patent Application Publication Mar. 25, 2010 Sheet 30 of 30 US 2010/0075914 A1 FIGURE 30 HERPESVIRUSES glycoprotein spikes = peplomers tegument lipid bilayer US 2010/0075914 A1 Mar. 25, 2010 METHODS FOR TREATING HERPES VIRUS years only to be reactivated, for example as shingles. The INFECTIONS name herpes comes from the Latin herpes which, in turn, comes from the Greek word herpein which means to creep. CROSS-REFERENCE TO RELATED This reflects the creeping or spreading nature of the skin APPLICATION lesions caused by many herpes virus types. 0001. This application claims priority from U.S. Provi 0004. There are at least 25 viruses in the family Herpes sional Patent Application No. 61/046.262, filed Apr. 18, 2008. viridae (currently divided into three sub-families; alpha, beta, The entire contents of that application is incorporated herein and gamma). Eight or more herpes virus types are known to by reference. infect man, as shown in Table 1. FIELD OF INVENTION TABLE 1 0002 The present invention relates to methods for treat Human herpesvirus 1 Herpes simplex type 1 (HSV-1) Alpha ing, killing, and/or inhibiting the growth of Herpesviruses in Human herpesvirus 2 Herpes simplex type 2 (HSV-2) Alpha Human herpesvirus 3 Varicella-zoster (VZV) Alpha human Subjects comprising topically administering to a Human herpesvirus 4 Epstein-Barr (EBV) Gamma human Subject in need thereof a nanoemulsion composition Human herpesvirus 5 Cytomegalovirus (CMV) Beta having antiviral properties. The present invention also relates Human herpesvirus 6/7 EXanthum Subitum Beta to methods for treating and/or preventing lesions associated Roseola infantum with Herpes virus infections in human and animal Subjects, Human herpesvirus 8 Kaposi's Sarcoma-associated herpes Gamma comprising topically administering to a human or animal virus (KSHV) Subject in need thereof a nanoemulsion composition having antiviral properties. 0005. Once a patient has become infected by a herpes virus, the infection remains for life. The initial infection may BACKGROUND OF THE INVENTION be followed by latency with subsequent reactivation. Herpes viruses infect most of the human population and persons A. Herpes Virus Infections living past middle age usually have antibodies to most of the 0003. Herpes viruses are a leading cause of human viral above herpes viruses with the exception of HHV-8. Herpes disease, second only to influenza and cold viruses. They are viruses are classified by their location in the latent state (Table capable of causing overt disease or remaining silent for many 2). TABLE 2 Properties of Herpes viruses Target cell Name Sub Family type Latency Transmission 1 HSV-1 Alphaherpesvirinae Mucoepithelia Neuron Close contact 2 HSV-2 Alphaherpesvirinae Mucoepithelia Neuron Close contact usually sexual 3 Varicella Zoster Alphaherpesvirinae Mucoepithelia Neuron Contact or virus (VSV) respiratory route 4 Epstein-Barr Gammaherpesvirinae B B Saliva Virus (EBV) lymphocyte, ymphocytes epithelia 5 Cytomegalovirus Betaherpesvirinae Epithelia, Monocytes, Contact, blood (CMV) monocytes, ymphocytes transfusions, lymphocytes and transplantation, possibly congenital others 6 Herpes Betaherpesvirinae T T Contact, lymphotropic lymphocytes ymphocytes respiratory virus and others and others route 7 Human herpes Betaherpesvirinae T T Unknown virus-7 (HHV-7) lymphocytes ymphocytes and others and others 8 Human herpes Gammaherpesvirinae Endothelial Unknown Exchange of virus-8 (HHV-8) cells body fluids? KSHV US 2010/0075914 A1 Mar. 25, 2010 0006 1. Herpes Simplex Virus 1 and 2 0012 Diseases caused by Herpes Simplex Viruses: Herpes 0007 Herpes simplex Virus 1 and 2 are very large viruses simplex 1 and 2 can cause severe disease. In each case, the with very similar characteristics. Almost any human cell type initial lesion looks the same. A clear vesicle containing infec tious virus with a base of red (erythomatous) lesion at the base can be infected by HSV. In many cells, such as endothelial of the vesicle. From this pus-containing (pustular) lesion, cells and fibroblasts, infection is lytic but neurones normally encrusted lesions and ulcers may develop.
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