COMPOSITIONS AND METHODS FOR THE TREATMENT OF CANCER

FIELD OF THE INVENTION

The present invention relates to the treatment of persons with Cancer.

BACK GROUND OF THE INVENTION

The Andrographis tree {Andrographis Paniculata) is a plant that grows wild in many parts of the world where the climate is warm, notably, India and Srilanka. Throughout India and Srilanka, different parts of the Andrographis plant, Inclusive of root, leaf and plant, are employed as remedies for various human ailments.

Andrographis paniculata is a herbaceous plant in the family Acanthaceae, native to India and Sri Lanka.

It is widely cultivated in southern Asia, where it is used to treat infections and some diseases, often being used before antibiotics were created. Mostly the leaves and roots were used for medicinal purposes. A.paniculata is distributed in tropical Asian countries. Native populations of A. paniculata are spread throughout south India and Sri Lanka which perhaps represent the centre of origin and diversity of the species.

Since ancient times, A.paniculata is used in traditional Siddha and Ayurvedic systems of medicine as well as in tribal medicine in India and some other countries for multiple clinical applications. The therapeutic value of Kalmegh is due to its mechanism of action which is perhaps by enzyme induction. The plant extract exhibits antity phoid and antifungal activities. Kalmegh is also reported to possess antihepatotoxic, antibiotic, antimalarial, antihepatitic, antithrombogenic, antiinflammatory, anti-snake venom, and antipyretic properties to mention a few, besides its general use as an immunostimulant agent. A study conducted at Bastyr

University, showed a significant rise in the mean CD4 lymphocyte level of HIV subjects after administration of lOmg/kg andrographolide.(6)

Andrographolide, the chief constituent extracted from the leaves of the plant, is biter water -soluble.

The hepatoprotective action of andrographolide is related to activity of certain metabolic enzymes.

Andrographis paniculata plant extract is known to possess a variety of pharmacological activities. Andrographolide, the major constituent of the extract, is implicated in its pharmacological activity. A study has been conducted on the cellular processes and targets modulated by andrographolide treatment in human cancer and immune cells. Andrographolide treatment inhibited the in vitro proliferation of different tumor cell lines, representing various types of cancers. The compound exerts direct anticancer activity on cancer cells by cell cycle arrest at GO/G1 phase through induction of cell cycle inhibitory protein p27 and decreased expression of cyclin dependent kinase 4 (CDK4). Immunostimulatory activity of andrographolide is evidenced by increased proliferation of lymphocytes and production of interleukin 2. Andrographolide also enhanced the tumor necrosis factor a production and CD marker expression, resulting in increased cytotoxic activity of lymphocytes against cancer cells, which may contribute for its indirect anticancer activity. The in vivo anticancer activity of the compound is further substantiated against B16FO melanoma syngenic and HT 29 xenograft models. These results suggest that andrographolide is an interesting pharmacophore with anticancer and immunomodulatory activities and hence has the potential being developed as a cancer therapeutic agent.

Andrographolide is the major constituent extracted from the leaves of the plant.

SUMMARY OF THE INVENTION

A pharmaceutical composition for the treatment of patients with Cancer forms one aspect of the invention. This composition comprises effective amounts of: components obtained from Andrographis {Andrographis Paniculata); and a protein supplement.

A pharmaceutical composition for the treatment of patients with Cancer forms another aspect of the invention. This composition is produced by: contacting powdered Andrographis (Andrographis Paniculata) with water to allow said water to extract components from said Andrographis powder to produce an aqueous extract; and mixing the aqueous extract with a protein supplement.

A method for treating a patient with Cancer forms yet another aspect of the invention. This method comprises the step of orally administering to said patient an effective amount of components of Andrographis in combination with a protein supplement.

Other advantage, features and characteristics of the present invention will become more apparent upon consideration of the following detailed description and the appended claims.

DETAILED DESCRIPTION

A preferred method for the treatment of Cancer is hereinafter described.

In this method 1.25 litres of potable water is mixed with 20 grams of commercially available powdered Andrographis, of the type derived from root, leaf and plant, the form a slurry.

The volume of the slurry is reduced, through boiling, to 750 mi., to extract components from the powdered Andrographis.

The reduced slurry is filtered through cloth to produce an aqueous extract containing components extracted from the Andrographis power and to also produce a residue of depleted Andrographis power.

The aqueous extract is mixed with 112.5 grams of a commercially available protein drink mix powder to produce a pharmaceutical composition in drink form. A serving of the drink is ingested by a patient 5 times daily, 5-6 days per week, such that the total amount of protein ingested by the patient is about 1 gram/ kilogram body weight/day. In this preferred method, the protein drink mix powder is of the type including about 89wt. % cross-flow microfiltered Whey protein Isolate, with the remaining 11 wt. % comprising Corosolic Acid, Protease I, Protease II, Peptizyme SP, Lactase, Amylase, Sucralose and Piperine Extract. For example, in the case of a 100kg Patient, each serving is prepared by mixing 150ml aqueous extract with 22.5 grams protein drink mix powder (which contains approx. 20grams protein).

In the event of extreme fatigue, treatment is arrested for 2-3 days and then resumed.
Treatment in this manner continues for at least 2-3 years.

While but a single embodiment of the present invention has been herein shown and described, it will be understood that various changes may be made.

For example, whereas the use of a commercially available protein drink mix supplement. As well, whereas the water used to extract components from powdered Andrographis in described to be used to form the basis of a drink, the water could equally be evaporated from the aqueous extract, to leave a Andrographis residue which could be mixed with protein and formed into a tablet, capsule or the like, for daily ingestion, or formed into a powder for subsequent mixture with water to form the drink. The drink itself could also be dehydrated and powdered, for subsequent rehydration and use at a later date. The protein supplement and Andrographis components could also be ingested separately. Whereas Whey Protein Isolate is taught for use as the protein supplement, other protein sources could be utilized. Compounds used by the body in protein formation, i.e. amino acids, could also be utilized, and are intended to fall within the meaning of the term "Protein supplements" as utilized herein. Accordingly, the invention should be understood as limited only by the claims appended hereto, purposively construed.

CLAIMS

1. A pharmaceutical composition for the treatment of patients with Cancer, said composition comprising effective amounts of:

components obtained from Andrographis (Andrographis paniculata); and a protein supplement.

2. A pharmaceutical composition according to claim 1, wherein the components are obtained by extracting powdered Andrographis with water.

3. A pharmaceutical composition according to claim 1, wherein the protein supplement comprises of about 89% by weight of whey protein isolate and about 11% by weight of pro performance enzyme complex (Protease I, protease II, peptizyme SP, lactase, amylase), sucralose, corosolic acid and piperine extract.

4. A pharmaceutical composition according to claim 1, wherein the components are obtained from the root, leaf and plant of Andrographis.

5. A pharmaceutical composition according to claim 1 in the form of drink.

6. A pharmaceutical composition for the treatment of patients with Cancer, said composition being produced by:

Contacting powdered Andrographis (Andrographis paniculata) with water to allow said water to extract components from said Andrographis powder to produce an aqueous extract; and

mixing the aqueous extract with a protein supplement.

7. A composition according to claim 6, wherein the powdered Andrographis is powder of Andrographis root, leaf and plant.

8. A composition according to claim 6, wherein the contacting step comprising boiling the water.

9. A composition according to claim 8, wherein about 40% of the water volume is evaporated during the contacting step.

10. A composition according to claim 6, wherein the water is contacted with the powdered Andrographis and thereafter filtered to produce the aqueous extract and a residue of depleted Andrographis powder.

11. A composition according to claim 6, wherein the powdered Andrographis and water are provided in the weight ratio of about 20:1250 for the contacting step.

12. A composition according to claim 6, wherein the aqueous extract and the protein supplement are mixed in a weight ratio of about 1500:225 in the mixing step.

13. A method for treating a patient with Cancer, said method comprising the step of orally administering to said patient an effective amount of components of Andrographis in combination with a protein supplement.

14. A method according to claim 13, wherein the effective amount of components of Andrographis and the protein supplement are provided in the form of a drink produced by:

Contacting powdered Andrographis (Andrographis Paniculata) with water to allow said water to extract components from said Andrographis powder to produce an aqueous extract; and

mixing the aqueous extract with a protein supplement.

15. A method according to claim 14, wherein the powdered Andrographis is powder of Andrographis root, leaf and plant.

16. A method according to claim 14, wherein the contacting step comprising boiling the water.

17. A method according to claim 14, wherein the water the water is contacted with the powdered Andrographis and thereafter filtered to produce the aqueous extract and a residue of depleted Andrographis power.

18. A method according to claim 14, wherein the aqueous extract and the protein supplement are mixed in a weight ratio of about 1500:225 in the mixing step.

19. A method according to claim 14, wherein, the initial treatment step, in the drink, the weight ratio of:

the grams of powdered Andrographis from which the components of Andrographis are derived;

to protein is about 1:5 and

1/5 of the total quantity of drink for a day is orally administered every three hours daily to the patient, such that the aggregate amount of the protein administered to the patient each day is 1 gram per kilogram of the body weight; and

for atleast 2-3 years and until Cancer cells are eliminated.