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(12) Patent Application Publication (10) Pub. No.: US 2008/0166435 A1 Pylypchuk (43) Pub

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US 2008O166435A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0166435 A1 Pylypchuk (43) Pub. Date: Jul. 10, 2008 (54) COMPOSITION AND METHODS OF USE OF Publication Classification AN IMMUNOMODULATOR (51) Int. Cl. A636/00 (2006.01) A636/53 (2006.01) (76) Inventor: Volodymyr Pylypchuk, Kiev (UA) A6IR 36/484 (2006.01) A636/886 (2006.01) A6IR 36/68 (2006.01) A6IP3L/00 (2006.01) Correspondence Address: A6IPL/I6 (2006.01) CONNOLLY BOVE LODGE & HUTZ, LLP A6IP 29/00 (2006.01) 1875 EYE STREET, N.W., SUITE 1100 A6IP37/00 (2006.01) A6IR 36/28 (2006.01) WASHINGTON, DC 20036 A636/73 (2006.01) A6IR 36/38 (2006.01) (52) U.S. Cl. ......... 424/730; 424/745; 424/725; 424/757; (21) Appl. No.: 11/965,377 424/765; 424/744; 424/737; 424/764; 424/738 (57) ABSTRACT (22) Filed: Dec. 27, 2007 A composition including one or more of elecampane rhizome (Inula sp.), fennel fruit (Foeniculum sp.), juniperberry (Juni perus sp.), licorice root (Glycyrrhiza sp.), oregano herb (Oreganum sp.), marigold flowers (Calendula sp.), rose hips Related U.S. Application Data (Rosa sp.), and thyme (Thymus sp.), or an extract thereof. The composition is useful for treating infectious diseases, for (60) Provisional application No. 60/877,631, filed on Dec. example viral and microbial infections, and for reducing the 29, 2006. toxic effects of chemotherapeutic agents. EgAm A relative values S. Arm A absolute values 2 Arm B relative values SAm Babsolute values Patent Application Publication Jul. 10, 2008 US 2008/O166435 A1 Fig. 1. |TT:LL,º |<??º ::|? gAm A relative values E. Arm A absolute values 2 Arm B relative values S. Arm Babsolute Values US 2008/0166435 A1 Jul. 10, 2008 COMPOSITION AND METHODS OF USE OF 0009. In another aspect, the inventors have found a method AN IMMUNOMODULATOR of treating a subject having an infectious disease comprising administering a composition comprising at least one plant CROSS REFERENCE TO RELATED material selected from the group consisting of Inula sp., Foe APPLICATIONS niculum sp., Juniperus sp., Glycyrrhiza sp., Oreganum sp., Calendula sp., Rosa sp., and Thymus sp., or an extract thereof, 0001. This application claims the benefit of U.S. Provi or a combination of the extracts, whereby liver function or sional Application No. 60/877,631, filedon Dec. 29, 2006, for incidence of adverse events is improved. all purposes. The entirety of this application is hereby incor 0010. In yet another aspect, the inventors have found a porated by reference. method of ameliorating adverse effects of chemotherapy in a Subject in need thereof comprising administering a composi FIELD OF THE INVENTION tion comprising plant material comprising Inula sp., Foenicu 0002 The invention regards medicinal herb compositions lum sp., Juniperus sp., Glycyrrhiza sp., Oreganum sp., Cal and their use in patient treatment. endula sp., Rosa sp., or Thymus sp., or a combination thereof, or extracts thereof or a combination of extracts thereof. BACKGROUND OF THE DISCLOSURE 0011. In another aspect, the invention is a method of treat ing disease, including infectious viral disease. 0003 Antiretroviral drug resistance, drug toxicity, and 0012 We evaluated the clinical benefit of the composition adherence are major concerns in the clinical management of No. 1 of the present invention in comparison to standard ART HIV infection. On the other hand, the immune activation in a multicenter trial conducted at four regional hospitals in caused by immune reaction to HIV, is now recognized as a Ukraine. Here we present data from a 32-week, open label, major cause of depletion of CD4" (CD4) T-cells and resulting three-arm trial in 70 HIV-infected individuals who were immunodeficiency. In fact, African monkeys, the natural treated either with zidovudine (AZT), lamividine (3TC), and hosts of simian immunodeficiency virus have adapted to this efavirenz (EFV), or with AZT/3TC/EFV in combination with retrovirus by blocking immune activation and thus remaining the composition of the present invention, or the composition healthy. An optimal therapeutic solution would be an effec of present invention alone, assigned to arms A, B, and C. tive and safe immunotherapy that could regulate the immune respectively. response in a manner favorable to a host. 0004 Dzherelo is an oral immunomodulating agent pro 0013 Data on treatment of patients suffering from tuber duced from 26 plant materials by the inventor. It contains culosis is also presented separately. concentrated extracts from medicinal plants. In vitro studies 0014. An immunomodulating agent has been evaluated in on cultured thymocytes and epithelial thymic cells have 70 HIV-infected individuals who were divided into three shown that Dzherelo can induce synthesis of serum thymic treatment arms: the first arm, serving as a control, received factor and other substances with thymus like activity. Experi standard antiretroviral therapy (ART), that is, zidovudine/ ments on laboratory animals demonstrated the restoration of lamividine/efavirenz (AZT/3TC/EFV); second, AZT/3TC/ endocrine function and increase of thymus weight after par EFV plus the composition of the present invention; and third, tial thymectomia. It has been Successfully used in the past for the composition of present invention alone which was given the therapy of various infectious diseases of viral origin Such orally, twice daily. During 32 weeks of follow-up CD4 cell as herpes and Epstein-Barr viruses. Prior evidence indicates counts increased progressively in all arms, reaching + 102. the tendency of Dzherelo to restore suppressed immunity +190, and +175 cells/mm, in arms A, B, and C, respectively. characteristic of chronic bacterial infections and malignant The proportion of patients who experienced adverse events diseases. Furthermore, Dzherelo has shown efficacy in treat attributable to study medication was 65%, 24%, and 5% in ment of autoimmune diseases. arms A, B, and C, respectively. The composition of the 0005 Pilot trials conducted by us in HIV-infected indi present invention appears to attenuate hepatic toxicity in viduals have shown that Dzherelo is safe, can increase the patients receiving ART as determined by liver function test. total and CD4 lymphocyte counts, and reduce the incidence Mean baseline values for ALT aminotransferase were 36, 62 of opportunistic infections. In addition it appeared to have a and 72 U/L in arms A, B, and C, respectively. At study favorable effect in diminishing the toxicity of antiretroviral conclusion, ALT values had risen to a mean 78 U/L in arm A drugs. but declined to 38 and 31 U/L in arms B and C, respectively. The composition of the present invention was also useful in 0006 Dzherelo is a complex mixture, however. An effec correcting AIDS-associated wasting. The average weight tive composition having fewer components would be desir gain was 1.4., 6.9, and 5.1 kg for arms A, B, and C. These able. clinical data indicate that the composition of present inven SUMMARY OF THE DISCLOSURE tion is very safe and has beneficial clinical effect in the treat ment of HIV and AIDS. 0007 We now present a simplified herbal composition 0015. Another embodiment of the invention comprises a prepared from essentially eight plant materials or extracts Somewhat more complex combination of plant materials use thereof. Surprisingly, this simpler version, termed composi ful, e.g., for treatment of tuberculosis patients. This embodi tion No. 1, had an equal effect as one that contained a higher ment is termed composition No. 2. number of herbs. 0016. The complex combination (“No. 2) of herbal mate 0008. In one aspect the inventors have identified a useful rials has Superior efficacy for Some illnesses than when said composition consisting essentially of plant material from materials are used alone. Such a combination can have fol Inula sp., Foeniculum sp., Juniperus sp., Glycyrrhiza sp., lowing ingredients, which can be administered together or as Oreganum sp., Calendula sp., Rosa sp., and Thymus sp., oran three sets of ingredients. The first set (Composition No. 2 set extract thereof, or a combination of the extracts. No. 1) will essentially contain medicinal plants such as Aloe US 2008/0166435 A1 Jul. 10, 2008 (Aloe arborescens), Common knotgrass (Polygonum avicu garticks (Bidens tripartite), Sage (Salvia officinalis), Dog lare), Yarrow (Achillea millefolium), Purple coneflower rose (Rosa canina), and Juniper berries (Juniperus commu (Echinacea purpurea), St. John's Wort (Hypericum perfora nis). Composition No. 3 can be combined with Composition tum), Centaury (Centaurium erythraea), Snowball tree ber No. 2, set 2 and/or set 3. ries (Viburnum opulus), Nettle (Urtica dioica), Dandelion (Taraxacum officinale), Sweet-sedge (Acorus Calamus), 0022. Another embodiment (termed composition No. 4) Oregano (Oreganum majorana), Marigold (Calendula offici relates to compositions that include, as a first component, the nalis), Seabuckthornberries (Hippophae rhamnoides), Ele active ingredient from Aloe and as a second component at campane (Inula helenium), Tormentil (Potentilla erecta), least one active ingredient isolated from the group of medici Greater plantain (Plantago major), Wormwood (Artemisia nal plants: Common knotgrass (Polygonum aviculare), Yar sp.), Siberian golden root (Rhodiola rosea), Cudweed row (Achillea millefolium), Purple coneflower (Echinacea (Gnaphalium uliginosum), Licorice (Glycyrrhiza glabra), purpurea), St. John's Wort (Hypericum perforatum), Cen Fennel (Foeniculum vulgare), Chaga (Inonotus obliquus), taury (Centaurium
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