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WO 2014/047562 A2 27 March 2014 (27.03.2014) P O P C T

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WO 2014/047562 A2 27 March 2014 (27.03.2014) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/047562 A2 27 March 2014 (27.03.2014) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/675 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US20 13/06 1190 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, 23 September 2013 (23.09.201 3) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (25) Filing Language: English OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (26) Publication Language: English SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (30) Priority Data: ZW. 61/703,981 2 1 September 2012 (21.09.2012) US (84) Designated States (unless otherwise indicated, for every (71) Applicant: EPIPHANY BIOSCIENCES [US/US]; One kind of regional protection available): ARIPO (BW, GH, California Street, Suite 2800, San Francisco, California GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, 941 11 (US). UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (72) Inventors; and EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ, LT, LU, LV, (71) Applicants : Volinsky, Fred [US/US]; One California MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, Street, Suite 2800, San Francisco, California 941 11 (US). TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, DONG, Steven [US/US]; One California Street, Suite KM, ML, MR, NE, SN, TD, TG). 2800, San Francisco, California 941 11 (US). Published: (74) Agent: DITTHAVONG MORI & STEINER, P.C.; 44 Canal Center Plaza, Suite 322, Alexandria, Virginia 223 14 — without international search report and to be republished (US). upon receipt of that report (Rule 48.2(g)) < © - (54) Title: METHOD OF TREATING AND/OR PREVENTING SHINGLES AND METHOD OF TREATING AND/OR PRE- © VENTING ZOSTER ASSOCIATED PAIN (57) Abstract: Described herein are methods for the treatment and/or prevention of shingles with antiviral agent or salts, solvates or hydrates thereof. Also described herein are methods for the treatment and/or prevention of post herpetic neuralgia with antiviral agents or salts, hydrates or solvates thereof. METHOD OF TREATING AND/OR PREVENTING SHINGLES AND METHOD OF TREATING AND/OR PREVENTING ZOSTER ASSOCIATED PAIN by Steven Dong & Fred Volinsky CROSS-REFERENCES [0001] This application claims the benefit of United States Provisional Application Serial No. 61/703,981 by Steven Dong and Fred Volinsky, filed September 2 1, 201 3 and entitled "Method of Treating and/or Preventing Shingles and Methods of Treating and/or Preventing Postherpetic Neuralgia," the contents of which are incorporated herein by this reference. FIELD OF THE INVENTION [0002] Described herein are methods for the treatment and/or prevention of shingles with antiviral agent or salts, solvates or hydrates thereof. Also described herein are methods for the treatment and/or prevention of post herpetic neuralgia with antiviral agents or salts, hydrates or solvates thereof. BACKGROUND OF THE INVENTION [0003] An estimated one million individuals in the United States alone develop herpes zoster (i.e., shingles) each year and the lifetime risk for each individual is estimated to be between about 10% and 20%. Shingles is caused by reactivation of varicella zoster virus (VZV) which infects nearly all humans. The virus is latent in sensory ganglia following primary infection which usually causes chicken pox. [0004] Shingles is characterized by a painful blistering skin rash in one or two dermatomes innervated by spinal or cranial nerve and associated pain. Shingles affects individuals of all ages but is most commonly observed in adults fifty years or older with the incidence increasing in older age groups and in individuals with compromised immune systems. [0005] Prodromal rash is the most obvious symptoms of shingles but, however, the VZV associated pain that accompanies viral reactivation requires, by far, the most medical intervention. Pain is typically triggered by the onset of viral replication in neuronal cells and in many situations this pain persists as zoster associated pain (ZAP). ZAP after 120 days is called postherpetic neuralgia (PHN), which is well beyond the clearing of rash and control of viral replication. [0006] ZAP and PHN impacts elderly patients most significantly since approximately 60% of shingles patients over age 60 develop PHN. However, current treatment of PHN, which relies on neuroleptics and analgesics, is frequently ineffective and also fails to treat the underlying cause of pain. [0007] Current treatment of acute herpes zoster is directed to inhibition of VZV replication with antiviral agents which usually leads to diminishment of the severity and duration of shingles. Common shingles treatments are valacyclovir ( 1 000 mg, TID) or famciclovir (500 mg, TID) or acyclovir (800 mg, 5 times daily) for 7 or ten days. A significant issue with the current therapy is the multiple daily dosing which leads to a lower rate of compliance and a poorer quality of life particularly with elderly patients. Further, current treatment regimens are not particularly effective in elderly patients and in treating post herpetic neuralgia. [0008] Accordingly, what is needed are antiviral agents, which ideally are dosed once daily and are particularly effective in treating older patients and patients suffering from or subject to post-herpetic neuralgia. SUMMARY OF THE INVENTION [0009] The current invention satisfies these and other needs by providing antiviral agent or salts, solvates or hydrates thereof for the treatment and/or prevention of shingles and for the treatment and/or prevention of post herpetic neuralgia with antiviral agents or salts, hydrates or solvates thereof. [0010] In one aspect, a method of treating or preventing shingles, shingles pain, or post-herpetic neuralgia in a subject is provided. The method comprises administering an antiviral agent or salts, hydrates, or solvates thereof to a subject in need thereof provided that the antiviral agent is not 02P(0)C02H or 02P(0)CH2C02H [0011] In another aspect, a method of treating or preventing shingles, shingles pain, or post-herpetic neuralgia in a subject is provided. The method comprises administering an antiviral agent or salts, hydrates, or solvates thereof to a subject in need thereof a therapeutically effective quantity of an antiviral agent or a salt, solvate, or hydrate thereof, wherein the antiviral agent is an antiviral agent selected from the group consisting of valomaciclovir stearate (EPB-348), octadecyloxyethyl-cidofovir (ODE-CDV, CMX-001 ), hexadecyloxypropyl-cidofovir (HDP-CDV), abacavir, adefovir, amantadine, amprenavir, arbidol, atzanavir, atripla, combivir, darunavir, delavirdine, didanosine, docosanol, edoxudine, efavirenz, emtricitabine, enfuvirtide, entecavir, entry inhibitors, antiretroviral, fomivirsen, fosamprenavir, fusion inhibitors, gardasil, ibacitabine, imunovir, idoxuridine, imiquimod, indinavir, inosine, integrase inhibitor, interferon type III, interferon type II, interferon type I, interferon, lamivudine, lopinavir, lopinavir, loviride, MK-051 8, maraviroc, moroxydine, nelfinavir, nevirapine, nexavir, nucleoside analogues, oseltamivir, peramivir, pleconaril, podophyllotoxin, protease inhibitors, reverse transcriptase inhibitors, ribavirin, rimantadine, ritonavir, saquinavir, stavudine, synergistic enhancer, tenofovir, tenofovir disproxil, tipranavir, trifluridine, trizivir, tromantadine, truvada, valavivlovir, vicriviroc, vidarabine, viramidine, zalcitabine, zanamivir, zidovudine, A-5021 ([1 'S,2'R)-9[[1 '2'-bis(hydroxymethyl)cycloprop-1 '-yl]- methyl]guanine]), cyclopropavir (CPV, ZSM-l-62), 2,4-diamino-6-R43-hydroxy- 2(phosphonomethoxy)propoxy]-pyrimidine (HPMPO-DaPy), N-(4-chlorobenzyl)-1 - methyl-6-(4-morpholinylmethyl)-4-oxo-1 ,4-dihydro-3-quinolinecarboxamide (PNU- 183792), 2-bromo-5,6-dichloro-1 -(beta-D-ribofuranosyl)benzimidazole (BDCRB), 1- (beta-L-ribofuranosyl)-2-isopropylamino-5,6-dichlorobenzimidazole (Maribavir, 1263W94), 3-hydroxy-2,2-dimethyl-N[4-{ [(5-dimethylamino)-1 - naphthylj-sulfonyl}- amino)phenyl}propamide (BAY 38-4766), 4-(2-amino-4- thiazolyl)phenyl derivative (BILS 79BS), N45-(aminosulfonyl)-4-methyl-1 ,3- thiazol-2-yl]-N-methyl-2-{4-(2- pyridinyl)phenyl}acetamide (BAY 57-1 293), 2H-3-(4-chlorophenyl)-3,4-dihydro-1 ,4- benzo-thiazine-2-carbonitrile-1 -oxide or 1, 1 -dioxide and 2-chloro-3-pyridin-3-yl-5, 6,7,8- tetrahydronindolizine-1 -carboxamide (CMV423). [0012] In yet another aspect, a method of treating or preventing shingles, shingles pain, or post-herpetic neuralgia in a subject is provided. The method comprises administering an antiviral agent or salts, hydrates, or solvates thereof to a subject in need thereof a therapeutically effective quantity of an antiviral agent, wherein the antiviral agent is a compound of Formula (I): (I) wherein: (i) R is hydrogen, hydroxy, mercapto, or amino; (ii) R 2 is hydrogen, hydroxy, fluoro, chloro, or amino; (iii) R 3 and R 4 are inde endently selected from amino, hydroxy, or an ether or ester residue thereof, or R 3 together with R is wherein: M is hydrogen; and n is 1 or 2 with the proviso that when R 2 is amino and R 3 and R 4 are hydroxy, R i is not hydroxy, and, in addition, when n is 1, R 2 is not hydrogen; or a salt, solvate, hydrate, or mixture thereof. [0013] In another aspect, a method of treating or preventing shingles, shingles pain, or post-herpetic neuralgia in a subject is provided. The method comprises administering an antiviral agent or salts, hydrates, or solvates thereof to a subject in need thereof a therapeutically effective amount of a compound of Formula (II): 2 (II).
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