WO2013190273A1

WO2013190273A1 - Therapeutic composition

Info

Publication number: WO2013190273A1
Application number: PCT/GB2013/051568
Authority: WO
Inventors: Wilma Evans
Original assignee: Wilma Evans
Priority date: 2012-06-20
Filing date: 2013-06-17
Publication date: 2013-12-27
Also published as: GB201210873D0; GB201420971D0; GB2539160A

Abstract

Described are compositions comprising willow bark, olive oil and rosemary. Also described is use of the compositions in treating disease or for relieving the symptoms of a disease, in particular cancer, enlargement or inflammation of the prostate (e.g. benign prostatic hyperplasia), backache and arthritis.

Description

THERAPEUTIC COMPOSITION

The present invention relates to novel therapeutic compositions in particular to compositions for treating and relieving the symptoms associated with cancer, for example prostate cancer.

Cancer is an illness effecting millions of people worldwide and, whilst many treatments have been identified, there is a great need to identify new treatments which are able to treat the disease and/or relieve its symptoms.

The illness is characterised by a wide variety of forms affecting a wide variety of organs and tissues in the human body. Whilst many effective therapies are available they are often associated with unwanted side effects and may be difficult or problematic to administer.

One particular type of cancer which has a high profile is prostate cancer. This type of cancer affects millions of men each year and a successful treatment for this disease is much sought after.

It is, therefore, an object of the present invention to seek to alleviate the above identified problems.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, there is provided a composition comprising willow bark, olive oil and rosemary.

Preferably, the composition comprises one or more pharmaceutically acceptable carriers, diluents or excipients. Preferably, the composition comprises petroleum jelly, preferably liquid petroleum jelly.

As such, in a preferred embodiment of the present invention, there is provided a composition comprising willow bark, olive oil, rosemary and petroleum jelly.

Preferably, the composition comprises saw palmetto, preferably saw palmetto extract. As such, in a preferred embodiment of the present invention, there is provided a composition comprising willow bark, saw palmetto, olive oil, rosemary and petroleum jelly.

Preferably, the willow bark is ground willow bark.

Preferably, the willow bark is in the form of a powder.

Preferably, the willow bark is from salix alba (white willow).

Preferably, the olive oil is from olea europaea.

Preferably, the rosemary is from rosmarinus officinalis.

Preferably, the rosemary comprises rosemary oil. Preferably, the rosemary oil is from rosmarinus officinalis.

Preferably the rosemary oil is rosemary essential oil. Preferably, the saw palmetto is in the form of a powder or liquid. Preferably, the composition is in the form of a liquid or gel. Preferably, the composition is in the form of an ointment.

Preferably, the composition comprises between about 10 g and about 20 g willow bark, or a combination of willow bark and saw palmetto, per 150 ml of final volume, preferably between about 12.5 g and about 17.5 g, most preferably about 15 g.

Preferably, the composition comprises substantially equal amounts of willow bark and saw palmetto. Preferably the composition comprises between about 5 g and about 10 g willow bark and between about 5 g and about 10 g saw palmetto, per 150 ml of final volume, preferably between about 6 g and about 9 g willow bark and between about 6 g and about 9 g saw palmetto, most preferably about 7.5 g willow bark and about 7.5 g saw palmetto.

Preferably, the composition comprises between about 30 ml and about 60 ml olive oil per 150 ml of final volume, preferably between about 40 ml and about 50 ml, most preferably about 45 ml.

Preferably, the composition comprises between about 85 ml and about 1 15 ml petroleum jelly per 150 ml of final volume, preferably between about 95 ml and about 105 ml, most preferably about 100 ml.

Preferably, the composition comprises between about 2 ml and about 8 ml rosemary oil per 150 ml of final volume, preferably between about 4 ml and about 6 ml, most preferably about 5 ml.

In one aspect of the present invention, there is provided an ointment comprising a composition as described herein.

Preferably, the composition is for topical administration to the skin of a patient, for example the pelvic region.

Preferably, the composition is a pharmaceutical composition. Preferably, the composition is a therapeutic composition.

In another aspect of the present invention, there is provided a method for treating a disease or for relieving the symptoms of a disease, the method comprising administering to a subject a therapeutically effective amount of a composition as described herein.

In another aspect of the present invention, there is provided a composition as described herein for use in therapy. Preferably, therapy comprises treatment of a disease or relieving the symptoms of a disease.

In another aspect of the present invention, there is provided use of a composition as described herein for treating a disease or relieving the symptoms of a disease.

Also provided by the present invention is a composition of the present invention for use in the manufacture of a medicament for the treatment of a disease or relieving the symptoms of a disease.

Preferably, the disease comprises cancer, enlargement or inflammation of the prostate (e.g. benign prostatic hyperplasia), backache or arthritis.

Preferably, the disease is cancer.

Preferably, the cancer is selected from pelvic cancer, blood cancer, adenocarcinoma, skin cancer and breast cancer.

Preferably, the cancer is primary or secondary (metastatic) cancer.

Preferably, the cancer is selected from bladder cancer, anal cancer, rectal cancer, chondrosarcoma (cancer of the cartilage), osteocarcoma, prostate cancer, testicular cancer, cervical cancer, ovarian cancer, uterine cancer, endometrial cancer, vaginal cancer, vulval cancer, renal cancer, bowel cancer, liver cancer or pancreatic cancer.

Preferably, the cancer is selected from cancer metastases located in the bladder, anus, rectum, cartilage, bone, prostate, testicle, cervix, ovary, uterus, endometrium, vagina, vulva, kidney, bowel, liver or pancreas.

Preferably the cancer is selected from leukemia, myeloma and lymphoma.

Preferably, the cancer is skin cancer. Preferably, the cancer is breast cancer. Preferably, the cancer is adenocarcinoma.

Preferably, the symptoms of a disease comprise pain, inflammation, oedema, difficulty in passing urine, general feeling of poor well-being.

Preferably, oedema comprises swollen legs (e.g. thighs), feet, ankles and/or hands.

Preferably, said treating or treatment comprises administering to a subject a therapeutically effective amount of a composition as described herein.

Preferably, the composition is administered to a subject at least once a day.

Preferably, the composition is administered to a subject once, twice or three times a day.

Preferably, the composition is administered to a subject for at least about two weeks, preferably, at least about three weeks.

Preferably, the composition is administered to a subject for between about two weeks and about six weeks, preferably between about three weeks and about six weeks.

Preferably, the composition is administered topically to the skin.

Preferably, the composition is administered at or near the site of a disease, for example a tumour.

Preferably, the disease is prostate cancer and the composition is administered topically to the pelvic region of a subject.

Preferably, the amount of the composition administered corresponds to the surface area of skin to which the composition is to be applied. In another aspect of the present invention, there is provided a method for preparing a composition as described herein, the method comprising mixing willow bark, olive oil and rosemary into a liquid or gel.

Preferably, the willow bark, olive oil and rosemary are mixed together in a non-metallic mixing receptacle, preferably to a paste.

Preferably, the method further comprises mixing petroleum jelly, preferable liquid petroleum jelly, with the willow bark, olive oil and rosemary.

Preferably, the method further comprises mixing saw palmetto, preferable powdered or liquid saw palmetto with the willow bark, olive oil and rosemary.

Preferably, the compositions of the present invention comprise one or more additional active compounds. Preferably, the one or more additional active compounds are therapeutically active compounds, for example in the form of an additional therapeutic compound for co- delivery with the compositions described herein.

DETAILED DESCRIPTION

Example embodiments of the present invention will now be described in detail.

The present invention relates to novel therapeutic compositions and their use in treating disease, for example the treatment of cancer and in relieving the symptoms associated with cancer.

Within this specification embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the invention.

Within this specification, the term "about" means plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2%. Within this specification, the term "subject" may be selected from a human or animal suffering from or at risk of suffering from a disease.

As used herein, the term "therapeutically effective amount" means the amount of a composition which is required to reduce the severity of and/or ameliorate at least one condition or symptom which results from the disease in question.

Pharmaceutical formulations can be prepared by mixing the composition with conventional pharmaceutically acceptable carriers, diluents or excipients. Examples of excipients include water, gelatin, gum arabicum, lactose, microcrystalline cellulose, starch, sodium starch glycolate, calcium hydrogen phosphate, magnesium stearate, talcum, colloidal silicon dioxide, and so on. Pharmaceutically acceptable carriers include solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like, compatible with pharmaceutical administration, unless use thereof is incompatible with the composition.

The formulations may also contain other pharmacologically active agents, and conventional additives, such as stabilizers, wetting agents, emulsifiers, flavouring agents, buffers, and the like.

The compositions of the present invention can be included in a container or dispenser together with instructions for administration.

Within this specification, the term "treatment" or "treating" means treatment of an existing disease and/or prophylactic treatment in order to prevent incidence of a disease. As such, the methods of the invention can be used for the treatment, prevention, inhibition of progression or delay in the onset of disease. EXAMPLE 1

Preparation of composition 1

15 g of powdered white willow (salix alba) was mixed with 45 ml olive oil in a non-metallic bowl using a plastic spoon. 100 ml liquid petroleum jelly was then added to the mixture followed by 5 ml rosemary essential oil and mixed to a smooth paste (total volume -150 ml).

Preparation of composition 2

7.5 g of powdered white willow (salix alba) and 7.5 g saw palmetto extract was mixed with 45 ml olive oil in a non-metallic bowl using a plastic spoon. 100 ml liquid petroleum jelly was then added to the mixture followed by 5ml rosemary essential oil and mixed to a smooth paste (total volume -150 ml).

Treatment of subjects

Subject 1

Subject 1 was a male of 42 years of age who had been suffering from prostate cancer. Symptoms included backache, oedema, and impaired urine flow.

Approximately 1 -2 ml of composition 1 paste (a fingertip amount) was applied to the pelvic region of subject 1 three times a day for two weeks. The paste was applied to the skin as near to the prostate as possible. Following treatment, symptoms had improved significantly to the extent that the subject was symptom free. In particular, pain and urine flow had improved significantly.

Subject 2

Subject 2 was a male of 49 years of age who had been suffering from prostate cancer for more than three years. Symptoms included a raised PSA level of over 10, back ache, oedema in lower limbs (particularly in the form of swollen ankles) and difficulty passing urine. Approximately 1 -2 ml of composition 1 paste (a fingertip amount) was applied to the pelvic region of subject 2 three times a day for four weeks. The paste was applied to the skin as near to the prostate as possible. Following treatment, symptoms had improved significantly. PSA levels were undetectable and the subject was no longer suffering from back ache, oedema or difficulty passing urine. The subject was back to his normal self.

Subject 3

Subject 3 was a male of 83 years of age who had been suffering from benign prostatic hyperplasia for several years. Symptoms included impaired urine flow and swollen ankles.

Approximately 1 -2 ml of composition 2 paste (a fingertip amount) was applied to the pelvic region of subject 3 three times a day for two weeks. The paste was applied to the skin as near to the prostate as possible. Following treatment, symptoms had improved significantly and urine flow was back to normal.

In all cases detailed above, no side effects were observed during or following treatment.

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications are covered by the appended claims.

Claims

1. A composition comprising willow bark, olive oil and rosemary.

2. A composition according to claim 1, further comprising one or more pharmaceutically acceptable carriers, diluents or excipients, preferably petroleum jelly.

3. A composition according to claim 1 or 2, further comprising saw palmetto.

4. A composition according to any preceding claim, where in the willow bark is in the form of a powder.

5. A composition according to any preceding claim, wherein the willow bark is from salix alba (white willow).

6. A composition according to any preceding claim, wherein the rosemary is rosemary oil, preferably rosemary essential oil.

7. A composition according to any preceding claim which is in the form of a liquid or gel.

8. A composition according to any preceding claim which comprises between about 10 g and about 20 g willow bark, or a combination of willow bark and saw palmetto, per 150 ml of final volume.

9. A composition according to any of claims 3 to 8, which comprises substantially equal amounts of willow bark and saw palmetto.

10. A composition according to any of claims 3 to 9 which comprises between about 5 g and about 10 g willow bark and between about 5 g and about 10 g saw palmetto, per 150 ml of final volume.

1 1. A composition according to any preceding claim, which comprises between about 30 ml and about 60 ml olive oil per 150 ml of final volume.

12. A composition according to any of claims 2 to 11, which comprises between about 85 ml and about 1 15 ml petroleum jelly per 150 ml of final volume.

13. A composition according to any preceding claim, which comprises between about 2 ml and about 8 ml rosemary oil per 150 ml of final volume.

14. An ointment comprising a composition according to any preceding claim.

15. A method for treating a disease or for relieving the symptoms of a disease, the method comprising administering to a subject a therapeutically effective amount of a composition according to any of claims 1 to 13.

16. A composition according to any of claims 1 to 13 for use in therapy.

17. A composition according to claim 16, wherein therapy comprises treatment of a disease or relieving the symptoms of a disease.

18. A method of claim 15 or composition of claim 17, wherein the disease comprises cancer, enlargement or inflammation of the prostate (e.g. benign prostatic hyperplasia), backache or arthritis.

19. A method or composition of claim 18, wherein cancer is selected from pelvic cancer, blood cancer, adenocarcinoma, skin cancer and breast cancer.

20. A method or composition according to claim 18 or 19, wherein cancer is selected from

(i) bladder cancer, anal cancer, rectal cancer, chondrosarcoma (cancer of the cartilage), osteocarcoma, prostate cancer, testicular cancer, cervical cancer, ovarian cancer, uterine cancer, endometrial cancer, vaginal cancer, vulval cancer, renal cancer, bowel cancer, liver cancer or pancreatic cancer; (ii) cancer metastases located in the bladder, anus, rectum, cartilage, bone, prostate, testicle, cervix, ovary, uterus, endometrium, vagina, vulva, kidney, bowel, liver or pancreas;

(iii) leukemia, myeloma or lymphoma.

21. A method or composition according to any of claims 18 to 20, wherein the cancer is primary or secondary cancer.

22. A method or composition according to any of claims 15 to 21, wherein the symptoms of a disease comprise pain, inflammation, oedema, difficulty in passing urine, general feeling of poor well-being.

23. A method or composition according to any of claims 15 to 22, wherein the composition is administered topically to the skin.

24. A method or composition according to any of claims 15 to 23, wherein the composition is administered at or near the site of a disease, for example a tumour.

25. A method for preparing a composition according to any of claims 1 to 13, comprising mixing willow bark, preferably powdered willow bark, olive oil and rosemary into a liquid or gel, for example a paste.

26. A method according to claim 25, wherein the willow bark, olive oil and rosemary are mixed together in a non-metallic mixing receptacle.

27. A method according to claim 25 or 26, which further comprises mixing petroleum jelly, preferable liquid petroleum jelly, with the willow bark, olive oil and rosemary.

28. A method according to any of claims 25 to 27, which further comprises mixing saw palmetto, preferable powdered or liquid saw palmetto with the willow bark, olive oil and rosemary.