RE: Composition of PC-SPES - Correction

[Guest guest]

Phil,

 

I cannot help you with the precise composition of PC-SPES because the US

Patent did not specify it - merely a range of ratios.

 

http://patft.uspto.gov/netacgi/nph-Parser?Sect2=PTO1 & Sect2=HITOFF & p=1 & u=%2Fn

etahtml%2Fsearch-bool.html & r=1 & f=G & l=50 & d=PALL & RefSrch=yes & Query=PN%2F566539

3

 

Results below for those unable to access the site. Hope that helps.

 

Sammy.

 

 

 

( 1 of 1 )

 

----------

----

United States Patent 5,665,393

Chen , et al. September 9, 1997

 

----------

----

Herbal composition for treating prostate carcinoma

 

 

Abstract

A composition comprising material from the following herbs: Panax

pseudo-ginseng Wall, Isatis Indigotica Fort, Ganoderma lucidum Karst,

Dendranthema morifolium Tzvel, Glycyrrhiza glabra L., Scutellaria

baicalensis Georgi, Rabdosia rubescens, Serenoa repens. Preferably, the

material from each of such herbs is an alcohol extract of dried, cut plants

and of the Panax the pseudo-ginseng Wall and each of the other materials are

present in a dried, weight-to-weight range of about 1:1-6. The composition

is administered orally or by suppository.

 

 

----------

----

Inventors: Chen; Sophie (Millwood, NY); Wang; Xuhui (Shanghai, CN)

Assignee: International Medical Research, Inc. (Brea, CA)

Appl. No.: 697920

Filed: September 3, 1996

 

Current U.S. Class: 424/489; 424/436; 424/461; 424/464; 424/465; 424/470;

424/728; 424/741; 424/757

Intern'l Class: A61K 009/14

Field of Search: 424/489,470,464,461,433,195.11,195.1,436

 

 

 

----------

----

 

References Cited [Referenced By]

 

----------

----

 

U.S. Patent Documents

5417979 May., 1995 Fan et al. 424/451.

 

Primary Examiner: Page; Thurman K.

Assistant Examiner: Benston, Jr.; William E.

Attorney, Agent or Firm: Herron; Charles J.

 

----------

----

 

Claims

 

----------

----

 

 

What is claimed is:

 

1. A composition comprising material from the following herbs: Panax

pseudo-ginseng Wall, Isatis Indigotica Fort, Ganoderma lucidum Karst,

Dendranthema morifolium Tzvel, Glycyrrhiza glabra L., Scutellaria

baicalensis Georgi, Rabdosia robescens and Serenoa repens.

 

2. The composition of claim 1, wherein the material from each of such herbs

is an alcohol extract of dried, cut plant parts.

 

3. The composition of claim 2, wherein the Panax pseudo-ginseng Wall and

each of the other materials are present in a dried, weight-to weight range

of about 1:1-6.

 

4. The composition of claim 1 in an ingestible form.

 

5. The composition of claim 4 wherein the ingestible form is selected from a

powder, capsule, tablet.

 

6. The composition of claim 1 in the form of a suppository.

 

7. A method of treating prostate cancer in an individual in need thereof

which comprises of administering a therapeutically effective mount of the

composition of claim 1.

 

8. The method of claim 7 which further comprises administering a

therapeutically effective amount of a compound selected from the group

consisting of:

 

luteinizing hormone releasing hormone, estrogen, antiandrogen,

gonadotrophin-releasing hormone and synthetic analogs thereof which have

hormone activity.

 

9. The method of claim 7 which further comprises administering a

therapeutically effective mount of a compound selected from the group

consisting of antibiotics, antimetabolites and cytotoxic agents.

----------

----

 

Description

 

----------

----

 

 

BACKGROUND OF THE INVENTION

 

Prostate carcinoma is the second leading cause of death among men. The

American Cancer Society estimates that 317,000 men will be diagnosed with

prostate cancer in 1996. While many of the small, localized prostate cancer

appear not to be life-threatening, those that spread to other sites in the

body are almost invariably fatal. The conventional treatment includes

radical prostactomy, nerve-sparing prostatectomy, external-beam radiation,

seed radiation, cryotherapy and hormone therapy. Each of these therapies has

serious side effects and other limitations (Review: Schroder F. H., Urology,

1995 September; 46 (3 Supplement A): 62-70). The long term results show a

rate of cancer recurrence after the treatment. Therefore, there is no

permanent cure.

 

Serum PSA (Prostate Specific Antigen) is a diagnostic parameter that has

been used to monitor the stages of cancer development and the progress of

the therapy. Serum PSA measures the substance emitted both by the normal

prostate gland and by cancerous tissue in the prostate gland. With normal

prostate gland, PSA reads between 0 to 4. Elevated PSA (higher than 5)

indicates a sign of prostate carcinoma, benign prostate hyperplasia or

prostatitis. The higher the PSA reading, the larger the volume of the cancer

(Das et al., Eds. Cancer of the Prostate, New York, N.Y., Marcel Dekker

Inc., 1993).

 

Serenoa repens or pygeum have been used to treat benign prostate hyperplasia

(Vahlensieck et al., Fortschr-Medicine, 1993, Jun. 30, 111 (18):323-326).

However, it appears there has been no application of herbs for the treatment

of prostatic carcinoma.

 

Fan and Wong, U.S. Pat. No. 5,417,979 discloses a combination of the herbs

Ganoderma lucidum Karst, Rabdosia rubescens and Glycyrrhiza glabra L. with

other herbs for treatment of cancers other than prostate cancer.

 

SUMMARY OF THE INVENTION

 

The present invention provides a composition of herbs and their extracts

which is useful to treat prostate carcinoma and which can also be used as a

dietary supplement. The combination of herbs and their extracts profoundly

improve prostate cancer patients' condition, such as a decrease in their

PSA, a stimulation in their immune system and an improvement in their

appetite and well-being.

 

The composition comprises Isatis Indigotica Fort, Panax pseudo-ginseng Wall,

Ganoderma lucidum Karst, Dendranthema morifoliun Tzvel, Glycyrrhiza glabra

L., Scutellaria baicalensis Georgi, Rabdosia rubescens, Serenoa repens or

extracts thereof. Preferably, the material from each of such herbs is an

alcohol extract of dried, cut plant parts. It is particularly preferred that

the Panax pseudo-ginseng Wall and each of the other materials are present in

a dried, weight-to-weight range of ratios of about 1:1-6.

 

The composition of the invention is preferably provided in an ingestible

form, such as, for example, a powder, capsule or tablet. Alternatively, the

composition can be provided in the form of a suppository.

 

The invention further provides a method of treating prostate cancer in an

individual in need thereof which comprises of administering a

therapeutically effective amount of the composition described herein.

 

The invention further provides such a method which further comprises

administering a therapeutically effective amount of a compound selected from

the group consisting of luteinizing hormone releasing hormone, estrogen,

antiandrogen, gonadotrophin-releasing hormone and synthetic analogs thereof

which have hormone activity.

 

The invention further provides such a method which further comprises

administering a therapeutically effective amount of a compound selected from

the group consisting of antibiotics, antimetabolites and cytotoxic agents.

 

BRIEF DESCRIPTION OF THE DRAWINGS

 

FIG. 1 graphically illustrates the DNA histogram of PC3 cell (Prostate

cancer cell line) in the presence of herbal extracts for 48 hours as

discussed in example 2. The histogram reflects the DNA content of the cancer

cell at different stage of the cell cycle. Cells in G2 and M phases of the

cell cycle have double the DNA content when incubated with the composition

of the invention for 48 hours. Simultaneously, cells in S phase and G1 phase

decrease.

 

FIG. 2 shows the histogram of PC 3 cells in the absence of the herbal

extract at 48 hours. No apparent change in the cytogram was observed.

 

FIG. 3 shows the decrease in PSA as a function of time after oral

administration of the herbal preparation of the invention as described in

Example 3, in combination with hormone therapy.

 

FIG. 4 shows the decrease in PSA as a function of time after oral

administration of the herbal preparation of the invention alone as described

in Example 4.

 

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

 

In this invention, groups of herbs were specifically chosen and combined

according to their biological activities. Although each herbal component

selected in this group has been well characterized and used before, their

combination for the treatment of prostate carcinoma is a new concept. As a

holistic approach to combatting prostate cancer, we select herbs which

possess the following biological activities: (1) Anti tumor activity; (2)

Immune stimulating activity; (3) Anti viral activity; (4) Anti inflammatory

activity; and (5) Anti benign prostate hyperplasia. Below are the categories

of herbs used in this invention based on the published studies. Most of the

herbs have multifunctional activities.

 

1. Anti tumor activity:

 

A) Ganoderma lucidum Karst: Maruyama et al., J. Pharmacobiodyn, 1989,

February 12 (2):118-23.

 

B) Robdosia ruberscens: Wang et al., Chung Hun-Chung-Liu-Tsa-Chih, 1986

July; 8(4):297-9.

 

C) Scutellaria baiculennsis Georgi: Konoshitna et at., Chem Phar. Bull.

Tokoyo 1992, February 40 (2):531-3.

 

2. Immune stimulating activity:

 

A) Ganoderma lucidum Karst: Ed. New Medical College od Jian-Su Province,

Encyclopedia of Chinese Medicinal Herbs, 1975, pp. 2395-99, by Shanghai

People's Publisher.

 

B) Isatis Indigotica Fort: Xu et at., Chung-Hsi-I-Chieh-Ho-Tsa-Chin, 1991,

June 11 (6):357-9, 3225-6.

 

3. Anti vital activity:

 

A) Scuteliana baicalenosis Georgi: Nagai et al., Biol. Pharm. Bull. 1995,

February 18 (2):285-9. Li ot oi, Cell Mol. Biol. Res. 1993:39:(22):119-24.

 

B) Dendranthema (Chrysanthemum) Morifolium Tzvel: He et al., J. Natural

Product, 1994 January 57 (1):42-51.

 

4. Anti inflammatory activity:

 

A) Scutellaria baicalensis Georgi: Butenko et al., Agents Actions, 1993, 39

Spec. No.: 49-51.

 

B) Blycyrrhiza glabra L.: Kobayashis et al., Biol. Pharm. Bull. 1995 October

18 (10):1382-5.

 

5. Anti Benign prostate hyperplasia activity:

 

Serenca repens: Dralkorn et al., Urologe A., 1995. 34(2):119-29.

 

The alcohol extracts of the above herbs were obtained in the lyophilized

powder form and were mixed and encapsulated in capsules. They were taken

orally as dietary supplement.

 

The weight of panax pseudo-ginseng Wall was defined as 1, the wight ratio of

Isatis indigotica Fort was from about 1 to about 4, of Ganoderma lucidum

Karst was from about 1 to about 6, of Dendranthema morifolium Tzvel was from

about 1 to about 4, of Glycyntiza glabra L was from about 1 to about 4, of

Scutellaria balcalensis Georgi was from about 1 to about 4, of Robdosia

rubersens was from about 1 to about 6, of Serenca repens was from about 1 to

about 6.

 

EXAMPLE 1

 

Preparation of Extract Composition

 

A preferred formulation of the composition of the invention is prepared to

contain the following: Isatis indigotica Fort, Panax pseudo-ginseng Wall,

Ganoderma lucidum Karst, Scutellaria baicalensis Georgi, Dendranthema

morifolium Tzvel, Glycyrrhiza glabra L., Robdoisa ruberscens, Serenoa

repens:

 

The alcohol extracts of the first seven herbs above were purchased from

Shanghai Medical College of Traditional (Shanghai, China).

They were obtained as powder form. The powder of Sernoa repens was purchased

from Frontier Cooperative Herb (Norway, Ind. 52318).

 

The above herbal powders were combined and mixed in a powder mixer (Won-Nen

Mixer, Model 8L-K-III, Shanghai). The weight of panax pseudo-ginseng Wall

was defined as 1, the relative weights of the rest of the ingredients were

from 1 to 6.

 

EXAMPLE 2

 

Effect of Herbal Extract on Cell-Cycle Progression of Prostate Carcinoma

Cell Line PC 3

 

Preparation of Herbal Solution

 

From the composition prepared as described in Example 1,300 mg was dissolved

in 1.0 mL of absolute ethanol and incubated at 37.degree. C. for one hour.

Ethanol extract of the herbal mixture was filtered through 0.2 micron

Millipore filter and used as stock solution. All dilutions were made with

the cell culture medium MEM and 10% serum purchased from Gibco BRL, Grand

Island, N.Y.).

 

Cell Line

 

PC 3 prostate cancer cells (ATCC #CRL 1435) were used in this study. All

cells were washed twice with buffered saline and were resuspended in RPMI

1640 medium (Gibco) supplemented with 10% fetal bovine serum and 100

units/ml penicillin, 100 ug/ml streptomycin and 2 mM L-glutathoine at a

density of 10.sup.9 cells/mL and cultured in the presence of 10 ug.mL of

phytohemagglutinin (PHA, Sigma, St. Louis, Mo.).

 

Results:

 

Cells were incubated with the herbal extract in concentrations of 0.01 to 4

..mu.L per mL of culture medium. The incubation times were 24 and 48 hours.

After incubation, the cells were washed with Hank's balanced salt solution

(HBSS) and the cells were fixed in ice-cold 70% ethanol.

 

Aliquots of fixed cells were rehydrated into HBSS and then stained with 1.0

..mu.g/ml DAPI and 10 .mu.g/mL sulforhodamine 101 (Eastman Kodak, Rochester,

N.Y.).

 

The blue DNA-specific DAPI fluorescence and red protein-specific

sulforhodamine fluorescence were detected by a flow cytpmeter (Ortho

diagnostic, Weswood, Mass.). The data from 0.5 to 1.0.times.10.sup.5 cells

were collected and the DNA histograms deconvoluted.

 

As illustrated in Table 1, FIG. 1 and FIG. 2, a profound decrease in the %

of both S and G1 phases was seen both at 48 hr. Accumulation of cells in G2M

phase from 36 to 67 was observed in the treated cells. Furthermore,

percentage for cancer cell apoptosis also increased in the treated cell

population. In contrast, no apparent change in the DNA cystogram was

observed in the absence of herbal extract at 48 hours.

 

 

TABLE 1

____

Cell Cycle Distribution

Cell Line Herbs (.mu.L/mL)

G1 S G.sub.2 M

____

PC3 0 34 30 36

PC3 2.0 20 13 67

____

 

 

 

These results demonstrate the potency of herbal extract in inducing cancer

cell death as well as in inhibiting cancer cell proliferation.

 

EXAMPLE 3

 

Clinical Study: Case 1

 

The patient in this case study was a 72 year old Asian male (in Taiwan). A

biopsy was performed at Taiwan Veteran's Hospital (TVH) in Taipei on Day 1.

The pathology report and bone scan indicated a prostate carcinoma

metastasized to bone. The PSA was measured to be 182.

 

Hormone therapy was begun on the patient on day 15, and included a

subcutaneous injection of 3.6 mG Zoladex (goserelin acetate implant) once

per month, and an oral administration of 250 mG of Eulexin (flutamide) 3

times per day. At that time the PSA level was 172. The treatment continued

for 3 months and the follow-up blood test (on Day 105) indicated a serum PSA

of 149. Hormone therapy improved patient's condition only slightly.

 

In addition to hormone therapy, the patient started a new alternative

therapy by oral administration of the herbal formula of the present

invention. The intake dosage of the herb composition was 1200 mG per day.

This combination treatment continued for two and one-half months. During

this period, the patient's appetite improved and his energy and well-being

were enhanced. There was no apparent adverse effect reported. On Day 182, a

follow-up serum PSA of 0.84 was reported.

 

The same medication was continued for another 3 months. A follow up blood

test (two weeks later) showed a constant PSA reading of 0.84.

 

The same medication was continued for another three months. At the time, a

follow-up bone scan showed almost complete resolution of multiple bone

metastases.

 

The same treatment was continued for another six months. At the time, a

follow-up serum PSA was measured to be 0.84. The results of the bone scan

reported that the appearance and the function of the prostate, bladder and

urethra were normal.

 

The dosage of the herbal formula was then reduced to 600-300 mG per day. The

reduced dosage was able to maintain the patients' healthy status. At

present, the patient lives a healthy and active life.

 

EXAMPLE 4

 

Clinical Study: Case 2

 

A white male, age 73, presented for a bone scan and biopsy which revealed

extensive bony metastatic disease involving the spine, pelvis, ribs, left

scapula, right clavicle and midshaft of the left femur. Serum PSA was

measured to be 1027.8

 

One week later, the patient started hormone treatment; regular subcutaneous

injection of Lupron (leuprolide acetate) every 28 days and 750 mG of Eulexin

(flutamide) per day where begun. The medication was continued for two and

one-half months. At that time, a follow-up serum PSA measured to be 0.9. The

patient was responding well to the drag therapy.

 

That same medication was continued, but after about three (3) years the

patient's PSA had increased to 6.4.

 

Six (6) months later, a repeat PSA test found a PSA level to 28.9. At this

time, Lupron was continued but the Eulexin was discontinued.

 

Nine (9) months later, serum PSA was found to be 32.8. Three weeks later,

hydrazine sulfate was added to the Lupron treatment regimen.

 

Six (6) months later, PSA was found to be 52.8. Hydrazine sulfate was

discontinued and a new treatment regimen was started: 600 nG of Nizoral

(ketoconazale) and 5 mg of prednisone per day.

 

Six (6) months later, serum PSA was 4.8 and the patient discontinued taking

Nizoral and prednisone. The only medication received was Lupron. Three (3)

months later, serum PSA had elevated to 89.0.

 

Three (3) months later, the patient started taking the herbal preparation of

the present invention. Dosage: 1800 mG per day. One week later, the dosage

of the herbal formula was increased to 2700 mG per day.

 

The following week, the patient's serum PSA was measured to be 3.8. The

dosage for the herbal preparation was also decreased to 1800 mG per day. The

patient received only 1/2 the dosage of Lupron.

 

A one-month follow-up of serum PSA was measured to be 1.6 (normal). The

dosage for the herbal formula was reduced to 900 mG per day. In addition,

Lupron was reduced to one-third dosage.

 

Two (2) months later, a follow-up PSA showed normal, 2.77. Lupron treatments

had been discontinued.

 

Twelve (12) days later, a follow-up PSA level of 2.73 was observed and the

dosage of the herbal formula was again reduced to 600 mG. No other

medication was given. The patient continued 600 mG of herbal formula daily.

 

Thereafter, the patient's serum PSA has stabilized in the range from 2.73 to

3.9 since, by taking only 300-600 mG of the composition of the present

invention.

 

 

* * * * *

 

----------

----

 

 

 

 

 

 

[]

08 October 2003 10:48

 

Composition of PC-SPES - Correction

 

 

Hi All,

 

http://www.usrf.org/breakingnews/pcspes-composition.html says

that PC-SPES contains Isatis Fm [Daqingye] and not Isatis Rx

[banlangen].

 

Yesterday, I summarised the PC-SPES composition from the

patent data at http://www.cooleyville.com/cancer/capcspat.htm as:

 

> Lingzhi (Ganoderma, Reishi) 3.5, Juchizonglan (Serenoa Repens)

> 3.5, Donglingcao (Rabdosia rubescens) 3.5, Huaijuhua

> (Dendranthema/Chrysanthemum morifolium) 2.5, Huangqin (Rx

> Scutellariae) 2.5, Gancao (Rx Glycyrrhizae) 2.5, Banlangen (Rx

> Isatidis Indigoticae) 2.5, Sanqi (Rx Notoginseng) 1.

 

That was not correct. What is the composition?

 

Is it:

 

1 Sanqi (Rx Notoginseng),

4 Daqingye (Fm Isatidis Indigoticae),

4 Gancao (Rx Glycyrrhizae),

4 Huaijuhua (Dendranthema/Chrysanthemum morifolium),

4 Huangqin (Rx Scutellariae),

6 Donglingcao (Rabdosia rubescens),

6 Juchizonglan (Serenoa Repens),

6 Lingzhi (Ganoderma, Reishi)?

 

or

 

100 Sanqi (Rx Notoginseng),

25 Daqingye (Fm Isatidis Indigoticae),

25 Gancao (Rx Glycyrrhizae),

25 Huaijuhua (Dendranthema/Chrysanthemum morifolium), 25

Huangqin (Rx Scutellariae), 17 Donglingcao (Rabdosia rubescens),

17 Juchizonglan (Serenoa Repens), 17 Lingzhi (Ganoderma,

Reishi)?

 

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

 

 

Chinese Herbal Medicine, a voluntary organization of licensed healthcare

practitioners, matriculated students and postgraduate academics specializing

in Chinese Herbal Medicine, provides a variety of professional services,

including board approved online continuing education.