Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-10-15
2001-03-06
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06197808
ABSTRACT:
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
The present invention relates to methods for treating the hyperplasia caused by a papilloma virus, such as Condyloma epithelial cells of mammals and which causes uncontrolled cell replication. There are many types of papilloma virus which infect human and animal species, but they all can infect the basal epithelial cells and persist in an episome or as DNA integrated into the host genome. The mechanism by which they cause tissue growth may be related to the E4 and E5 proteins they all produce in related forms, which appear to interact with p54 and other host proteins which control the cell cycle. The effects of papilloma virus which have been described include genital warts or
Condylomata acuminate
, common warts, plantar warts, bovine papillomas, and cervical intra-epithelial neoplasia in women.
The detection of human papilloma virus (“HPV”) in
Condyloma acuminata
involve a method of taking a tissue sample or a smear from the infected area and determining the DNA of the virus. According to this method, the detection rate is almost 100%.
Types HPV6 and 11 of the virus are the ones most commonly detected and because HPV16 has been detected in malignant squamous cell carcinoma from cancer of the penis, cancer of the cervix and
Condyloma acuminata
, there is a strong possibility that HPV16 is related to the malignancy of
Condyloma acuminata.
Means for the treatment of
Condyloma acuminata
caused by human papilloma virus which have been tried include physical means such as surgical excision, electrocauterization, cryosurgery, laser therapy, etc., and medications such as applications of Podophyllin, 5-Fluorouracil, Bleomycin, Interferon, Imiquimod, etc., which are presently available. However, surgical treatment is distressing for the patient, considering the site of infection, and with topical applications there is the concern of side-effects. The aforesaid medications work either by cytotoxic tissue destruction or by enhancing the cellular immune response by causing local inflammation. Accordingly, a conclusive treatment has heretofore not been available.
Condyloma acuminata
has a high rate of recurrence, and a complete cure is difficult unless treated constantly. Therefore, a treatment which has a high degree of safety and is convenient is strongly desired.
A treatment regimen for hyperplasia caused by a papilloma virus, such as
Condyloma acuminata
, which would be easy for the patient to administer, is desired. For example, it would desirable to have a medication which can be taken orally and can be applied to the affected area by the patients themselves and which would provide good results after a relatively short period of use and have no side-effects.
SUMMARY OF THE INVENTION
The present inventors searched for a natural substance which has no side-effects, may be safely applied for a long period of time by the patients themselves and is notably effective. After extensive testing, the inventors discovered that catechin, a component of tea which is an everyday beverage, is effective for treating hyperplasia caused by papilloma virus, and thus the present invention was developed.
Accordingly, the present invention relates to a method for the treatment of hyperplasia caused by papilloma virus, comprising concomitantly orally and topically administering to a human an effective anti-hyperplasia amount of a tea extract containing catechin as a main component. More specifically, the present invention concerns the treatment of hyperplasia caused by a papilloma virus such as
Condyloma acuminata
, common warts, plantar warts and cervical infra-epithelial neoplasia by a combination of topical administration of at least one tea catechin and oral administration of at least one tea catechin.
DETAILED DESCRIPTION OF THE INVENTION
The tea catechins for use in the present invention are shown below in the following formula I
wherein R
1
represents H or OH and R
2
represents H or
The tea catechins are more specifically, epicatechin, epicatechin gallate, epigallocatechin gallate, gallocatechin, etc. (including derivatives thereof). These catechins can be used singly, or two or more may be mixed together. Out of these it is particularly desirable to have (−)-epigallocatechin gallate as a main component. Examples of tea catechin compositions for use in the present invention include the following: POLYPHENON 100™ (produced by Mitsui Norin Co.; Composition: (+)-gallocatechin 1.44 wt %, (−)-epicatechin 5.81 wt %, (−)-epigallocatechin 17.57 wt %, (−)-epicatechin gallate 12.51 wt %, (−)-epigallocatechin gallate 53.90 wt %; or POLYPHENON E™ (produced by Mitsui Norin Co.; Composition: (−)-epicatechin 10.8 wt %, (−)-epigallocatechin 9.2 wt %, (−)-epicatechin gallate 6.5 wt %, (−)-epigallocatechin gallate 54.8 wt %, (−)-gallocatechin gallate 4.0 wt %).
The formulations for the topical administration of the tea catechin compounds or tea catechin composition employed for the treatment of hyperplasia according to the present invention can be, for example, in the form of an ointment such as a cream, a jelly, or an emulsion; or in the form of a suppository such as a capsule, and usually the tea catechin component is combined with an excipient, an extending agent, an emulsifier, a dispersing agent, etc. Vaseline is suitable as a base for the ointment. For the ointment, the content of tea catechin should be between 2 to 20% by weight, preferably between 12 to 18% by weight, and more preferably 15% by weight. In the case of a suppository, the content of tea catechin should be 50 to 500 mg/capsule, preferably 200 to 300 mg/capsule, or more preferably 250 mg/capsule.
A typical usage example for the ointment is to apply the ointment directly to the infected area of the external genital organs or vagina, a vaseline cream containing 2 to 20% by weight catechin, from once to several times everyday for a period of 1 to 2 months. A typical usage example for the suppository in the case where, for example, the infected area is the cervix or the vagina, is to insert a capsule containing 50 to 500 mg tea catechin, from once to several times everyday for a period of 1 to 2 months.
There is no danger of side-effects from the use of tea catechins for the treatment of hyperplasia, since the tea catechins are natural substances derived from tea, which is commonly consumed regularly, and it may be taken for long periods of time. Moreover, for topical administration, this medication may be easily applied to or inserted in the infected area by the patients themselves. The composition of the present invention for a treatment of hyperplasia has a very high potential for practical use.
The formulations for oral administration of the tea catechin compounds or tea catechin composition utilized in the present invention can be, for example, in the form of tablets, capsules, granules, powders or syrups. The pharmaceutical preparations for oral administration can be produced in a conventional manner using adjuvants that are generally known in the art, such as excipients, binders, disintegrating agents, lubricants, stabilizers, corrigents and the like. Although the dosage may vary depending upon the symptoms and age of the patient, the nature and severity of the disease or disorder, in the case of oral administration to an adult human patient, the tea catechin compounds used in the present invention may normally be administered at a total daily oral dose of from 100 to 2,000 mg, either in a single oral dose, or in divided oral doses, for example, two or three times a day.
REFERENCES:
patent: 5135957 (1992-08-01), Shimamura
patent: 5159069 (1992-10-01), Hirayama et al.
patent: 5211944 (1993-05-01), Tempesta
patent: 5576013 (1996-11-01), Williams et al.
patent: 5605929 (1997-02-01), Bombardelli et al.
patent: 5648377 (1997-07-01), Bombardelli et al.
patent: 5795911 (1998-08-01), Cheng et al.
patent: 22 06 570 (1972-09-01), None
patent: 42 11 238 (1993-10-01), None
patent: 0 417 385 (1991-03-01), None
patent: 2 293
Ahn Woong Shick
Cheng Shu Jun
Hara Yukihiko
Lee Insu P.
Wang De Chang
Cancer Instititute (Hospital), Chinese Academy of Medical Scienc
Frishauf, Holtz Goodman, Langer & Chick, P.C.
Reamer James H.
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