AU2002301401A1 - Psoriasis treatment - Google Patents

Description

11-OCT-2002 16:20 FROM AJ PRRK TO 0061262837999 P.04 Regulation 3.2

AUSTRALIA

PATENTS ACT, 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

Name of Applicant: Actual Inventor: Address for service HEROSE PHARMA INTERNATIONAL PTE LTD Jing Hua TANG in Australia: A J PARK, Level 11, 60 Marcus Clarke Street, Canberra ACT 2601 Invention Title: PSORIASIS TREATMENT The following statement is a full description of this invention, inlticling the best method of perfonnrming it known to mn/us 11-OCT-2002 15:20 FROM A3 PARK<T 0162399P0 TO 0061262837999 2 PSORIASIS TREATMENT Field of the Invention The present invention relates to a psoriasis treatment and in particular to a traditional Chinese medicine (TCM) preparation tt has been found to be highly effctive in treating Psoriasis and provide a greatly reduced risk of relapse.

Background to the Invention Traditional Chinese Medicine (TCM) is the use of traditional Chinese medical theories and therapies, including acupuncture, herbal medicines, nutrition, massage and movement therapies (such as Tai Clhi) to reinforce and stimulate the body's internal strength to cure disease.

Psoriasis is a non-contagious chronic skin diseas that appear in different forms and levels of severity. It is generally characterised by patches of raised red skin covered by a flaky white buildup. Psoriasis is usually a mild condition and a number of treatments are effective in managing the clinical symptoms. Approximately seven million people in the United States suffer from psoriasis with estimated new cases numbering at about 150,000 to 260,000 new cases every year. The average age of diagnosis is 28 while psoriasis most commonly appears between 15 and years of age. Cases in infants and the elderly are not uncommon. Psoriasis is generally diagnosed by examination of tie skin.

The exact cause of psoriasis is unknown but it is believed to be due to faulty immune systemn 2s signalling. Errant signals accelerate the production of skin cells which accumulate on the skin surface because the body is not able to shed them fast enough. Some patients have a genetic predisposition to psoriasis but an external envirornental trigger is generally necessary to initiate symptoms. Identified triggers include emotional stress injury to the skin, infectous and drug reactions.

k-Vrm"W4CCSPECLA71MWdt 1I-OCT-2002 16:20 FROM RJ PARK TO 0061262B37999 P.06 3 There are several forns of psoriasis including: Plaque psoriasis; Guttate psoriasis: small dot like lesions; Inverse psoriasis: intense inflammation and little scaling; Erythrodermic psoriasis: intense sloughing and inflammation of the skin; Generalised pustular psoriasis: weeping lesions and intense scaling; and Localised pustular psoriasis.

The most common form is plaque psoriasis with 4 out of 5 sufferers having this type. "Plaques" are well-defined patches of red, raised skin with a flaky, silvew, white buildup on top called scale composed of dead skin cells. Between 10% and 30% of people with any of these forms of psoriasis also develop psoriatic arthritis. Psoriasis most commonly appears on the scalp, knees, elbows and torso but can develop anywhere including nails, palms, soles, genitals and face.

Sufferers with mild psoriasis (about 75% to 80% of sufferers) have patches of psoriasis on less than 2% of their body. Moderate to severe sufferers (about 20% to 25%) have psoriasis on upwards of 2% and 10% of their bodies respectively.

About 400 people die a year in the United States from psoriasis complications, usually due to extensive shedding of skin effecting their ability to regulate body temperature, ward off infections and retain fluids.

There is at present no recognised cure for psoriasis but many treatments exist that can ease or clear symptoms for prolonged periods. Treatments include topical therapy using steroids, calcipotrine, vitamin A, anthralin, salicylic acid, sunlight (or otler photo therapy), moisturiser and bathing. Systemic medication using methotrexate, oral retinoids and cyclosporine have also been shown to be effective. However, prolonged use is either not possible or carries associated risks. Combination or rotational therapy combining the above treatments is used in serious or persistent cases.

l:WUbraryZCCL E071N. lc 11-OCT-2002 16:21 FROM RJ PARKTO0628399P7 TO 0061262837999 P.07 4 Problems with existing remedies arm that they may not be effective for all sufferers. Individuals often must receive customised treatmnents because their bodies react differently to different treatments. Furthermore, once treatment ceases, the risk of relapse is often high, especially on re exposure to environmental triggers.

While TCM is known to be usefWl in treating psoriasis, existing TCM treatments may suffer from the same problems as treatments offered by Western medicine in that they are not effective in all cases or are not able to prevent relapse.

to The present application discloses a TCM formulation found to be highly effective in treating psoriasis with a greatly reduced risk of relapse.

The present application also discloses that the treatment of the invention is more effective in patients that have never taken immune system suppressing drugs or medication which affects the is production of bone marrow and white blood cells.

Object of the Invention It is therefore an object of the invention to provide an effective TCM therapy for psoriusis; and/or to overcome or address at least one of the disadvantages of the prior art; and/or to at least provide the public with a useful choice.

Summary of the Invention According to the broadest aspect of their invention there is provided a composition including or consisting of Gan Jiang, Dan Shen 1 Jiang Xiang, H-uang Qi, Gui Zhi; and Cang Zhu wherein the composition is highly effective in treating psoriasis. Preferably, the compositions also provides a greatly reduced risk of relapse.

IrUJar9LrYUEW(PECW7ISS8Ldoc 11-OCT-2002 16:21 FROM AJ PARK i1-OT-202 6:2 FRM 9 PRI*(TO 0061262837999 P.08 As used herein, "highly eftibeive" means: I. At least 90% of patients who have never taken immune system suppressing drugs or medication which affects production of bone marrow and white blood cells recover, preferably fully; and 2. At least 80% recovery rate of patients who have taken these drugs recover, preferably fully.

As used herein, "greatly reduced risk of relapse" means skin problem areas are cured, rashes disappear, skin colour returns to normal and there is no relapse of disease for at least two years.

Mast patients, irrespective of whether they have taken immune systemn suppressing drugs or medication which affects the production of bone marrow and white blood cells, experience this result Preferably the composition of the invention further includes or consists of one or more of Bal Sha, Dang Shen, and Yi Yi Ron.

According to a second aspect of the invention there is provided a method of treating psoriasis including or consisting of administration of a composition of the invention.

Preferably the mrethod of the invention is carried out in the absence of stimulants, anti-tumour drugs, alcohol and drugs that suppress the immune systan.

According to a third aspect of the invention there is provided a use of a composition of the invention in the manufacture of a formulation for treating psoriasis.

In a preferred form the composition of the invention is prepared by mixing together the component herbs. Alternatively extracts, preferably organic extracts, of each of the components may be used.

II'LUbAhryWMDCCW719U8.d 11-OCT-2002 16:21 FROM RJ PARK TD 0061262837999 P.09 In a preferred form of the invention, the composition of the invention further includes or consists of one or more materials selected from the gaoup comprising adjuvents, plasticisers, excipients, diluents, carriers, binders, lubricants, glidants and tabletting compounds. In alternative forms the composition of the invention may be included in food additives, drink additives, dietary supplements and pharmaceutical formulations. Prefrably the composition of the invention is prepared in capsule form for oral administration.

The compounds useful herein are also known as: Chinese Name Latin Botanical English Gan Jiang Rhizoma Zingiberis Zingiber officinale Dried Ginger Dan Shen Radix Salviac Salvia miltiorrhiza Danshen Root Red Sage Root Miltiorrhizae Bge Salvia Root Jiang Xiang Lignum Dalbergiae Dalbergia odorifera Rosewood Heart Wood Odoriferae T. Chen Huang Qi Radix Astragali Astragalus Astragalus Root /Membranous membranaceus Milkvetch Root Mongolian (Fisch.) Bge. Milkvetch Root Gui Zhi Ramulus Cinnamrnomi Cinnamomum cassia Cassia Twig, Cinnamon Twig Presi Cang uZh Rhizoma Atractylodes lancea Swordlike Atractylodes Atractylodis Lanceae Rhizome Rhizome I Chinese Atractylodes Rhizome Bai Shao Radix Paeoniae Alba Paconia lactiflora White Paeony Root Pall Dang Shen Radix Codonopsis Codonopsis pilosula Pilose Asiabell Root Pilosulae Nannf. Moderate Asiabell Root I Szechwon Tangshen Root Yi Yi Ren Semen Coicis Coix lacrymajobi L. Coix Seed ma-yuen Staph.

1%U\braryXDCXSPECW7;I IU6d 11-OGT-2002 16:21 FROM P5 PARKTO0628399.1 TO 0061262837999 7 This invention may also be said broadly to consist in the pants, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or said features, and where specific integers are mentioned herein which have no equivalents in the at to which this invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

The invention consists of the forgoing and also envisages constructions of which the following gives examples.

Detailed Description of the Invention Psoriasis a chronic disease of the skin with a high tendency df relapse. Reports have estimated that there are presently approximately 50 million patients worldwide. There is a need for an effectivc treatment of psoriasis that minimises relapse.

Is Presently, clinical treatment for psoriasis is usually carried out using stimulants or twnoureontrol drugs. However, these drugs only provide temporary relief and do not cure the patient of the disease. The majority of these drugs affect the production of bone mnarrow and white blood cells.

Patients are also required to abstain from many types of food. Medication of this type may lead to complications and hinders the normal fuinctioning of the immune system.

After more than 20 years of clinicial observation, it is observed that besides itchiness, skin damage and other sin problems, most psoriasis patients wAil also prefer warmth to cold. This phenomenon is especially obvious in patients whos conditions are more serious. The patients either perspire very little or not at all. According to the theory of Traditional Chinese Medicine (TCM), weaknes in the "Yang" will lead to sensitivity to external cold while weakness in the "Yin" will lead to sensitivity to internal heat. The composition of the present invention is based on the therapeutic method of warming the "Yang" and promoting blood circulation. The composition of the invention has found to be highly effective in treating psoriasis with a greatly 3o reduced risk of relapse.

Ih.Uhft3EyDCCSSPEC%471BLdfl 11-OCT-2002 16:22 FROM AJ PARK TO 0061262837999 P.11 8 No Previous Use of Immune System Suppressing drug Patients who have never been treated with immunosuppressants will benefit the most from the composition of the present invention. Patients will first notice improvement of symptoms beginning from the upper part of the body and gradually moving downwards upon taking the composition of the present invention. About a week after first treatment, new rashes will stop forming and old rashes (thick and scaly rough patches) will improve. With continuing treatment, the thick and scaly skin patches will reduce and thin down. Upon recovery, the affected skin becomes fair and will take on the tone of healthy skin. Patients will usually achieve a full recovery within three months with no relapse. Patients in this category show approximately a 96% success rate with the treatment using the composition of the invention.

Previous Treatment with (Immune System Suppressing drug) For patients who have previously been treated with immunosuppressants, improvements of their symptoms will begin from the lower part of the body gradually moving upwards upon taking the composition of the invention. A small number of patients may see improvement in all parts of the body concurrently. About 30 days after beginning treatment, some new onset rashes will be surrounded by a white circle while rashes will cease gradually and the thick and scaly skin patches will reduce and thin down. Patients in this category show approximately an 87% success rate using the composition of the invention. The patient's affected areas will take on the tone of healthy skin last.

After the old rashes in the form of thick and scaly skin patches, the affected area becomes greyish and in some cases it will take more than two years before these areas take on the tone of healthy skin. It is believed this is due to the adverse affect of immunosuppressants.

For patients where the affected areas do not become totally fair (healthy skin toned), it has been observed that relapse may occur, Where old rashes disappear and the affected area turns fair this indicates full recovery and no relapse will occur.

1-ibrsryVXQSCACPE71ifStc 11-OCT-2002 16:22 FROM A5 PARK TO 0061262837999 P.12 9 Approximately 6% to 7% of patients exhibit a ring recovery style where the rashes thin down and disappear towards a centre point. Patients of this category will take a relatively longer time to reach a full recovery and the patient's head area will tale on the tone of healthy skin lastly.

The following example reports results observed from use of the composition of the invention by 252 patients.

Example Clinical Inforawtion Patient's presented the following 0inical information: The patients' skin disorder exhibited in the form of patches of raised, rough, red and scaly rashes. On the surface were multi4ayered silvery white scaly rashes and these were accompanied by mild or serious itchiness.

This condition often spread to the whole body, especially the hands, legs and knees, in the form of small uneven patches.

Acute breakout with a tendency of relapse was common and usually related to seasonal changes.

Heredity played a part in some patients- I!9jr*r9A0CQ37y E4flade 11-OCT-2002 16:22 FROM AJ PARK TO 0061262837999 P.13 Treatment Group The treatment group comprised 136 males and 116 females, 252 patients in total. The following tables provide further information on the characteristics of the treatment group.

Age Number of cases 1.10 24 11-20 71 21-30 96 31-40 41 41-50 12 8 TOTAL 252 Illness duration Number of cases 0-1 year (shortest) years (most common) 6-15 years (second most common) 73 31-38 years (longest) 2 TOTAL 215 Age upon treatment Number of cases 6-16 years 29 17-36 years 145 37-56 years 57 years 13 TOTAL 262 T:Unr9~CQrpWECk71Soc 11-0CT-2002 16:22 FROM AJ PARK TO 0061262837999 P.14 11 The 252 patients were able to be divided into two groups: Group 1: Patients who have never taken immune suppressing drugs or medication that controls the production of bone marrow and white blood cells.

Group 2: Patients who have taken this medication prior to being treated with a composition of the present invention.

63 patients 189 patients Treatment Method A composition comprising Gan Jiang, Dan Shen, Jiang Xiang, Huang Qi, Gui Zhi and Cang Zhu was used.

The composition was administered in capsule form to both Groups 1 and 2. An equal dosage of the capsule was administered at the same time to each patient, three times a day. Each phase consisted of a 30 day treatment with five capsules per dosage. Patients may require up to thre phases of treatment, depending on their individual requirements.

Reaction to Treatment The following results were observed: Result A: Skin problems were completely cured, rashes disappeared, skin colour returned to normal, and there was no relapse of the disease for at least two years.

Result B: Skin problem areas were cured but skin colour did not return to normal and disease relapse occurred several months later.

IAUbIr*ryUK50SPKCW7lgsdot 11-OCT-2002 16:23 FROM PJ PARK TO 0061262637999 12 Group Result A Result B Total 160 cases 3 cases 63 2 l64 cases(8.% 25 cases 189 TOTAL 224 128 (11.1%)25 Comparison of the results between the two groups gave PN0.05.

S Analysis About 95 of patients in Group 1 were cured completely after about three months of treatment, regardless of the length of time they had suffered from psoriasis and their age when they first contracted the disease. During the treatment process, recovery began from the head downwards without any relapse. The areas with skin problems turned white gradually and reurned to normal skin colour after about a month. After medication was withdrawn there was no relapse for at least 2 years.

Patients in Group 2 took a much longer period to achieve recovery compared to Group I patients.

Recovery took place throughout the whole body concurrently for some patients, while for others, recovery occurred gradually from the legs upwards& There was frequent relapse during the treatment process but the conditions generally improved after each relapse. When the condition improved, the problem skin areas first turned a greyish brown and often took at least several months to return to normal skin colour. Continued treatment with the composition of the invention was required until the skin fully recovered. Approximately 87% of patients in Group 2 recovered.

The above describes some preferred embodiments of the invention and indicates several possible modifications but it will be appreciated by those skilled in the art that other modifications can be made without departing from the scope of the invention.

L %LA ra t$DCOS PECA71 S&dec

Claims (1)

11-OCT-2002 16:23 FROM AJ PARK TO 0061262837999 P.16 13 THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS: 1. A composition including or consisting of Gan Jiang, Dan Shen, Jiang Xiang, Huang Qi, Gui Zhi and Cang Zhu, wherein the composition is highly effective in treating psoriasis. 2. A composition of claim 1 which provides a greatly reduced risk of relapse. 3. A composition of claim 1 or 2 further including or consisting of one or more of Bai Shao, Dang Shen and Yi Yi Ren. 4. A composition of any one of claims I to 3 further including or consisting of one or more of adjuvents, plasticisers, excipients, diluents, carriers, binders, lubricants, glidants and tabletting compounds. 5. A method of treating psoriasis including or consisting of administering a composition of any one of claims I to 4to a patient in need thereof. 6. A method of claim 5 wherein said method is carried out in the absence of stimulants, anti- tumour drugs and/or drugs that suppress the immune system. 7. A use of a composition of claim 1 to 4 in the manufacture of a formulation for treating psoriasis. 8. A composition as claimed in any one of claims 1 to 4 substantially as herein described. 9. A method as claimed in claim 5 or 6 substantially as herein described. A use as claimed in claim 7 substantially as herein described. HEROSE PHARMA INTERNATIONAL PTE LTD Dated this llth day of October 2002 By their Patent Attorneys A J PARK On behalf of the lcalmnt P e r .ryW C l:1Library\DCC\SPEC47l885.dOc