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  Nucleoside analogs in combination therapy of herpes simplex infectionsUSPTO Application #: 20050222016Title: Nucleoside analogs in combination therapy of herpes simplex infections Abstract: A pharmaceutical product comprising a nucleoside analogue active against herpes simplex virus, such as penciclorivir/famciclovir, and an immunosuppressant, as a combined preparation for simultaneous, separate or sequential use in the treatment and/or prevention of herpes simplex virus infections. (end of abstract)
Agent: Novartis Corporate Intellectual Property - East Hanover, NJ, US Inventor: Malcolm Richard Boyd USPTO Applicaton #: 20050222016 - Class: 514011000 (USPTO) Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Peptide Containing (e.g., Protein, Peptones, Fibrinogen, Etc.) Doai, Cyclopeptides, Monocyclic The Patent Description & Claims data below is from USPTO Patent Application 20050222016. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This invention relates to the use of a nucleoside analogue active against herpes simplex virus (HSV), in the treatment of herpes simplex virus infections, and to pharmaceutical compositions containing the two components. [0002] The disease indication for herpes simplex subtype 1 (HSV-1) is herpes labialis (cold sores), and the disease indication for herpes simplex subtype 2 (HSV-2) is genital herpes. [0003] Herpes Labialis is a common world-wide disease characterized by repeated attacks of versicular eruptions most commonly recognised on the lips and perioral skin. Many patients report pain, swelling and significant cosmetic concerns associated with subsequent ulceration of lesions. Although generally a minor disease, in some patients the consequences of frequent severe attacks can be debilitating. The disease is naturally self-limiting in immunecompetent individuals and recurrent episodes last 7-10 days. [0004] First infection with genital herpes may be severe (primary first episode) if the patient has no previous history of labial or genital herpes infection, while a less severe disease occurs if any antibody response is developed through previous exposure to HSV--non-primary first episode. The most common sequel to primary genital herpes infection is recurrent disease. The attack rate varies greatly but is likely that patients will experience on average 4-5 episodes per year. Symptomatology in these episodes are characterised by painful lesions which progress from papules and vesicles through to ulcers and finally crusts. Lesions may be accompanied by a range of symptoms including pain, tenderness, itching and swelling of the affected area. [0005] EP-A-141927 (Beecham Group p.l.c.) discloses penciclovir, the compound of formula (A): 1 [0006] and salts, phosphate esters and acyl derivatives thereof, as antiviral agents. The sodium salt hydrate of penciclovir is disclosed in EP-A-216459 (Beecham Group p.l.c.). Penciclovir and its antiviral activity is also disclosed in Abstract P.V11-5 p. 193 of `Abstracts of 14th Int. Congress of Microbiology`, Manchester, England 7-13 September 1986 (Boyd et. al.). [0007] Orally active bioprecursors of the compound of formula (A) are of formula (B): 2 [0008] and salts and derivatives thereof as defined under formula (A); wherein X is C.sub.1-6 alkoxy, NH.sub.2 or hydrogen. The compounds of formula (B) wherein X is C.sub.1-6 alkoxy or NH.sub.2 are disclosed in EP-A-141927 and the compounds of formula (B) wherein X is hydrogen, disclosed in EP-A-182024 (Beecham Group p.l.c.) are preferred prodrugs. A particularly preferred example of a compound of formula (B) is that wherein X is hydrogen and wherein the two OH groups are in the form of the acetyl derivative, described in Example 2 of EP-A-182024, hereinafter referred to as famciclovir. [0009] The compounds of formulae (A) and (B) and salts and derivatives thereof have been described as useful in the treatment of infections caused by herpes viruses, such as herpes simplex type 1 and herpes simplex type 2. All references herein to penciclovir/famciclovir include pharmaceutically acceptable salts, such as the hydrochloride, and solvates, such as hydrates. [0010] When used herein the term `immunosuppressant` includes pharmaceutical agents such as cytotoxic agents such cyclophosphamide and cyclosporin A and corticosteroids such as hydrocortisone and dexamethasone and non steroidal anti-inflammatory agents. [0011] In one preferred aspect, the immunosuppressant is cyclosporin A. [0012] The anti-herpes simplex virus properties of nucleoside analogues such as penciclovir/famciclovir or ayclovir/valaciclovir are potentially enhanced by administering the compound in conjunction with an immunosuppressant. The rationale is that in mice infected with herpes simplex virus, treatment with an antiviral agent to achieve clearance of the virus is particularly effective when the mice are immunosuppressed with cyclosporin A. [0013] Accordingly, the present invention provides a pharmaceutical product comprising a nucleoside analogue active against herpes simplex virus, such as acyclovir/valaciclovir or penciclovir/famciclovir, and an immunosuppressant, as a combined preparation for simultaneous, separate or sequential use in the treatment and/or prevention of herpes simplex virus infections. [0014] The present invention also provides a method of treatment and/or prophylaxis of herpes simplex virus infections, which comprises administering to a human or animal subject, a nucleoside analogue active against herpes simplex virus, such as acyclovir/valaciclovir or penciclovir/famciclovir, and an immunosuppressant or a pharmaceutically acceptable salt or ester thereof. [0015] The invention further provides the use of a nucleoside analogue antiviral active against herpes simplex virus, such as acyclovir/valaciclovir or penciclovir/famciclovir for the manufacture of a medicament for administration in conjunction with an immunosuppressant or a pharmaceutically acceptable salt or ester thereof, for the treatment and/or prevention of herpes simplex virus infections. [0016] Co-administration of penciclovir/famciclovir with an immunosuppressant is particularly useful for the treatment of severe and/or prolonged herpes simplex virus infections. [0017] The antiviral such as penciclovir/famciclovir and the immunosuppressant or a pharmaceutically acceptable salt or ester thereof, may be administered as a single pharmaceutical composition comprising effective amounts of the two active ingredients. Alternatively the two active ingredients may be co-administered in the form of two separate pharmaceutical compositions for simultaneous or sequential use. Normally the active ingredients will be administered separately according to the normal dosage and administration regimen for the ingredients given alone. Commencement of administration may be either with the immunosuppressant or the antiviral. [0018] The unit doses of the nucleside analogue may be administered, for example, 1 to 4 times per day. The exact dose will depend on the route of administration and the severity of the condition being treated, and it will be appreciated that it may be necessary to make routine variations to the dosage depending on the age and weight of the patient and immunocompromised patients may require an increased dosage. [0019] Immunosuppressants are administered according to the conventional route of administration for the immunosuppressant employed. [0020] When the two active ingredients are administered as separate preparations, they are preferably given enterally, such as orally or parenterally (e.g. intramuscularly or, more particularly, intravenously). [0021] According to a further aspect the invention provides a pharmaceutical composition, for use in human or veterinary medicine, comprising a nucleoside analogue active against herpes simplex virus, such as acyclovir/valaciclovir or penciclovir/famciclovir, and an immunosuppressant or a pharmaceutically acceptable salt or ester thereof. [0022] Compositions according to the invention may be formulated in conventional manner using one or more physiologically acceptable carriers or excipients. Thus the compositions may, for example, be formulated for oral, buccal, parenteral or rectal administration. Compositions for administration by the oral route, in the form of for example tablets or capsules, are preferred. [0023] Compositions for oral use such as tablets and capsules may be prepared by conventional means with pharmaceutically acceptable excipients such as binding agents (e.g. pregelatinised maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose); fillers (e.g. lactose, micro crystalline cellulose or calcium hydrogen phosphate); lubricant (e.g. magnesium stearate, talc or silica); disintegrants (e.g. potato starch or sodium starch glycollate); or wetting agent (e.g. sodium lauryl sulphate). Tablets may be coated by methods well known in the art Liquid preparations for oral administration may take the form of, for example, solutions, syrups or suspensions, or they may be presented as a dry product for constitution with water or other suitable vehicle before use. Such liquid preparations may be prepared by conventional means with pharmaceutically acceptable additives such as suspending agents (e.g. sorbitol syrup, cellulose derivatives or hydrogenated edible fats); emulsifying agents (e.g. lecithin or acacia); non-aqueous vehicles (e.g. almond oil, oily esters, ethyl alcohol or fractionated vegetable oils); and preservatives (e.g. methyl or propyl-p-hydroxybenzoates or sorbic acid). The preparations may also contain buffer salts, flavouring, colouring and sweetening agents as appropriate. [0024] Preparations for oral administration may be suitably formulated to give controlled release of one or both active ingredients. Continue reading... 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