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Curaderm Clinical Trials

Dermatologist Phase 3 Clinical Trials and Open Studies U.K Hospitals, 2002

The clinical trial experience has shown that the BEC was safe.  The dermatologists who conducted the Phase III clinical trials with BEC 5 concluded that BEC5 is a topical preparation, which is safe and effective. BEC 5 therapy is ideal for outpatient treatment and is a much needed alternative to surgery for BCC. The clinical trials of BEC5 done by the multi-centres, comprised of application of BEC5 twice daily for eight weeks.

Phase III clinical trials involving ten centres in the United Kingdom were completed in 2002. The general success rate of the glycoalkaloid (BEC) cream was 78 percent. Longer duration therapy with BEC would have resulted in higher success rates. These results were comparable to Clincal Trials 1 & 2 andindependent doctor studies into Curaderm previously obtained over the last 20 years.

A subsequent open study trial carried out at the Dermatology Department at the Royal London Hospital it was also shown that the glycoalkaloid cream was effective on morpheoic BCC lesions, which are a type of invasive BCC.

Clinical Trial Centres and Study Investigators:

1. Dr R Cerio
The Royal London Hospital

2. Professor A Finlay
University of Wales College of Medicine

3. Dr R A C Graham-Brown
Leicester Royal Infirmary

4. Dr J Hawk
St Thomas Hospital

5. Dr M Rustin
Royal Free Hospital

6. Dr D L Roberts
Singleton Hospital

7. Dr P Kersey
Derriford Hospital

8. Professor C E M Griffiths
Hope Hospital

9. Dr L J Cook
St Mary’s Hospital, Portsmouth

10. Dr G R Sharpe
Royal Liverpool Hospital, Liverpool

Efficacy:
Royal London has a large dedicated skin cancer clinic as it is a Skin Cancer Center for the North East Thames Network. This fact, coupled with the results of the first trial, was instrumental on Royal London’s conduct of second open study. Success rates in this open trial paralleled the multi-center efficacy rate of 78%. Success was defined as zero presence of basal cell carcinoma after histological examination of samples extracted from the lesion site by punch biopsy.

We consider that this rate of treatment success more than justifies the physician considering BECs as an alternative to currently predominant treatment such as surgical excision or cryotherapy.

Cosmetic Evaluation:
BEC results in ulceration of the lesion site during treatment. However, we have observed that post treatment the wound is quick replenished with normal tissue and that residual scarring is minimal. Whether such scarring proves more or less extensive than that consequent upon a number of factors including lesion size, location and so on. However, it can be said that the cosmetic results offered by treatment with BEC5 are comparable to that resulting from surgical excision.

Resource Effectiveness
Basal Cell Carcinoma is a slow growing locally inavasive malignant skin tumor which mainly affects Caucasians. Dermotologists, plastic surgeons and radiotherapists jointly manage the affliction, such management usually involves surgery. The risks of surgical intervention are well known.

Moreover, excision of basal cell carcinoma from the facial area often involves reconstructive, which can be both time consuming and costly. Hence an alternative, safe and efficacious method of treatment of basal cell carcinoma that does not require physician or hospital attendance must be encouraged.

In our view and experience BEC5 is a tropical preparation, which is safe and effective, ideal therapy for outpatient treatment. Hence BEC5 is a much needed alternative to surgery for basal cell carcinoma. This is the commonest cancers in Caucasians worldwide and the prevelence continues to increase with an increasing ageing population.

It is a cost effective treatment for both primary and secondary skin cancer care.

Clinical Trials Australia

Over the last few decades, medical research has been published showing evidence of Curaderm-BEC5 as a safe and effective skin cancer treatment. Several international scientific groups have since confirmed Curaderm-BEC5’s scientific work and endorsed Dr Cham’s conclusions as to how and why BEC exerts its anticancer properties. For reputable evidence this is extremely important.

Independent Scientists:

Independent scientists throughout the world have confirmed my hypothesis as evidenced by their publications and/or citations as follows –

  • Nakamura et al, 1996;
  • Chang et al, 1998; 
  • Hsu et al, 1996; 
  • Morille et al, 2001; 
  • Verpoorte, 1998
  • Kuo et al, 2000;
  • Roddick et al, 2001;
  • Chataing et al, 1998; 
  • Roddick et al, 1990;

Published research and Clinical Trials

The following articles have been published between 1987 and 2003 in highly respected medical journals, Such journals are read by medical practioners and scientific researchers so they can be informed of important medicinal developments.

Glycoalkaloids from Solanum sodomaeum L. are Effective in the Treatment of Skin
Cancers in Man

Cham, B. E. and Heather Meares, M. M. (1987).
Cancer Letters 36, 111-118.
Summary
A cream formulation containing glycoalkaloid purified from the plant species Solanum sodomaeum L. is
effective in the treatment of the malignant human skin tumours; basal cell carcinomas (BCC), squamous cell
carcinomas (SCCs) and the beign tumours; keratoses and keratoacanthomas. Histological analyses of
biopsies taken before, during and after treatment give compelling evidence of the efficacy of the formulation.
The treated lesions did not occur at least 3 years after c essation of therapy. The observed complete
regressions were; 20/24 for the BCCs; 5/6 for the SCCs; 23/23 for the keratoacanthomas.

Biochemical, haematological and urinanalytical studies demonstrated that there were no adverse effects on
the liver, kidneys or haematopoietic system during treatment. Normal skin treated with the formulation
likewise was free from adverse histological or clinical effects. The data indicate that glycoalkaloids of this
type are therefore potentially useful in the treatment of several types of human skin cancers.
Introduction have resulted in the identification of well established antineoplastic agents such as vincristine. It has also
been reported that extracts from the Solanum species are effective in treating cancers. (1) More recently,
the glycoalkaloid B-solamarine which is extracted from S. dulcamara was shown to posses anticancer
properties (2). In a previous paper it was reported that S. sodomaeum L.contains a mixture of glycoalkaloids;
the aglycone which is present in all the glycoalkaloids is solasodine (3). This communication shows
evidence that these glycoalkaloids are effective against Sarcoma 180 activity in mice. Some toxicity studies
of these glycoalkaloids are also presented.

HPLC of glycoalkaloids from Solanum sodomaeum L
Planta Med, 1987
Most recently, it was also shown that glycoalkaloids extracted from the fruit of another Solanum species
namely Solanum sodomaeum L. possessed antineoplastic activity both in mice (3) and in humans. In this
paper, we report the extraction, identification and purification of these glycoalkaloids from Solanum
sodomaeum L.

HPLC of glycoalkaloids from Solanum sodomaeum L
Cham, B. E. and Wilson, L. (1987).
Planta Med. 53, 59-61.
Abstract
Glycoalkaloids were extracted from plant material of Solanum sodomaeum L. High-performance liquid
chromatographic studies indicated that several glycoalkaloids were present. The sugar moiety of the
glycoalkaloids consisted of a mixture of glucose, rhamnose, and galactose. Mass spectral analyses showed
that all the glycoalkaloids contained solasodine. Solasodine and solamargine were identified and were
of the glycoalkaloids from plant material, expressed as glycoalkaloid/100g wet weight, was highest for ripe
fruit (0.83+-0.11), followed by unripe fruit (0.45+- 0.08), leaves (0.14+_0.01), and stems (<0.04) with
progressively decreasing yields. Over twofold difference glycoalkaloid yield was observed when ripe fruit of
two districts was extracted.

Introduction
Many well- known alkaloids currently used in Medicine are extracted from plants. B-solamarine, a
glycoalkaloid extracted from Solanum dulcamara is a tumour inhibitor (1,2). Most recently, it was also shown
that glycoalkaloids extracted from the fruit of another Solanum species namely Solanum sodomaeum L.
possessed antineoplastic activity both in mice (3) and in humans. In this paper, we report the extraction,
identification and purification of these glycoalkaloids from Solanum sodomaeum L.

Monograph on the compound BEC
Drugs of the Future, 1988
More recently, it was shown that the anticancer properties derived from glycoalkaloids. The glycoalkaloids
from various Solanum species identified as having anticancer properties (3-5, 7-9) are (B-solamarine (8),
solaplumbin(9) and BEC (3-5).

HPLC of glycoalkaloids from Solanum sodomaeum L
Cham, B. E. and Wilson, L. (1987).
Planta Med. 53, 59-61.
Abstract
Glycoalkaloids were extracted from plant material of Solanum sodomaeum L. High-performance liquid
chromatographic studies indicated that several glycoalkaloids were present. The sugar moiety of the
glycoalkaloids consisted of a mixture of glucose, rhamnose, and galactose. Mass spectral analyses showed
that all the glycoalkaloids contained solasodine. Solasodine and solamargine were identified and were
present at similar concentrations, representing 6 7% of the total extracted glycoalkaloids. The extraction
yield of the glycoalkaloids from plant material, expressed as glycoalkaloid/100g wet weight, was highest for
ripe fruit (0.83+-0.11), followed by unripe fruit (0.45+- 0.08), leaves (0.14+_0.01), and stems (<0.04) with
progressively decreasing yields. Over twofold difference glycoalkaloid yield was observed when ripe fruit of
two districts was extracted.

Introduction
Many well- known alkaloids currently used in Medicine are extracted from plants. B-solamarine, a
glycoalkaloid extracted from Solanum dulcamara is a tumour inhibitor (1,2). Most recently, it was also shown
that glycoalkaloids extracted from the fruit of another Solanum species namely Solanum sodomaeum L.
possessed antineoplastic activity both in mice (3) and in humans. In this paper, we report the extraction,
identification and purification of these glycoalkaloids from Solanum sodomaeum L.

CURADERM-BEC5
The Medical Journal of Australia, 1989

Although curaderm-BEC5 has been marketed since 1987 as a treatment for solar keratoses only (which
aspect was not addressed by Beardmore et al.’s investigation) subsequent to this study many patients with
basal-cell and squamous-cell carcinomas have been treated by (R.E); all showed complete regression
(unpublished observations) and some patients have demonstrated marked regression – both clinical and
histologically of the metastases of melanoma.

CURADERM, To the Editor
Ross Evans, MB RS. (1989).
The Medical Journal of Australia, vol. 150

To the Editor: In response to the letter by Beardmore et al. (MJA, January 2, 1989), we wish to bring to
readers’ attention, the results of our development and research on the treatment of skin lesions with
Curaderm.

Studies over the past 10 years have shown that some Solanum species contains glycoalkaloids’ that are
effective in the treatment of internal cancer in animals 2.3. These glycoalkaloids (in the formulation BEC 02)
have been shown to be effective in treating skin cancers in humans.
Twenty eight patients with 62 lesions that included keratoses, keratoacanthomas, and basal cell and
squamous-cell carcinomas were studied. Histological examination showed conclusively that after follow-up
studies indicate clearly that no recurrences have occurred. Our subsequent studies have discovered the
mode of action of the glycoalkaloids (unpublished observations), and with this knowledge, Curaderm was
formulated as has been shown to be superior to the earliest BEC 02 preparation in the treatment of skin
cancers.

The studies by one of us (R.E) of the treatment of 30 patients with 74 solar keratoses with Curaderm, which
contains the new glycoalkaloid preparation, showed complete regression in all cases. No clinical regression
was noted in eight patients who received placebo. No recurrences have been noted over three years.
Although curaderm has been marketed since 1987 as a treatment for solar keratoses only (which aspect
was not addressed by Beardmore et al.’s investigation) subsequent to this study many patients with basalcell
and squamous-cell carcinomas have been treated by (R.E); all showed complete regression
(unpublished observations) and some patients have demonstrated marked regression – both clinical and
histologically of the metastases of melanoma.

Unfortunately, Beardmore et al. did not consult us before undertaking their study. What their study does
prove is that if such skin lesions are not treated correctly, as directed by the prescribing information that is
supplied with Curaderm, complete regression will not occur.

References
Ross Evans, MB RS
1 St Paul Terrace
Spring Hill, OLD 4004

Bill E. Cham PhD
Department of Medicine,
University of Queensland
Clinical Science Building, Royal Brisbane Hospital
Herston Road, Herston. QLD 4029.

Brian Daunter PhD
Department of Obstetrics and Gynaecology,
University of Queensland
Clinical Science Building, Royal Brisbane Hospital
Herston Road, Herston. QLD 4029.

Topical Treatment of Premalignant Skin Lesions by Very Low Concentrations of a
Standard Mixture (BEC) of Solasodine Glycosides Skin Cancers with Curaderm-BEC5.
Cancer Letters, 1990 A cream formulation containing high concentrations (10%) of a standard mixture of solasodine glycosides
(BEC) has been shown effective in the treatment of malignant and benign human skin tumours

Solasodine glycosides. Selective Cytoxicity for Cancer Cells and Inhibition of
Cytotoxicity by Rhamnose in mice with sarcoma 180

Cancer Letters, 1990
Solasodine glycosides have antineoplastic activity in cell culture [1-3], animal[1,2,4,5],
and in human [1,2,6,7 Cham and Evans, unpublished data]. It has been demonstrated that specific endogenous lectins which are present on the plasma membranes of susceptible cells recognize and bind the sugar moiety of the solasodine glycosides [2,3].
The glycosides are subsequently internalised and cause cell death [2,3].
Solasodine glycosides. Selective Cytoxicity for Cancer Cells and Inhibition of

Cytotoxicity by Rhamnose in mice with sarcoma 180
Cham, B. E., Daunter, B. (1990).
Cancer Letters, 55, 221-225.

Summary
BEC, a standard mixture of solasodine glycosides is effective in vivo against murine sarcoma 180 (S180),
whereas the aglycone solasodine at equimolar concentrations is ineffective. The efficacy of BEC against
S180 in vivo can be inhibited by rhamnose. Mice which are in their terminal stage administration of BEC at
concentration of BEC three times the LD100 for normal mice. These observations suggest that the binding
of solasodine glycosides on tumour cells may be mediated through the monosaccharide rhamnose, which
forms part of solasonine, solamargine and di-glycosides of solasodine in BEC. Furthermore, these results
provide evidence that BEC selectively destroys tumour cells relative to normal cells in vitro.

Introduction
Solasodine glycosides have antineoplastic activity in cell culture [1-3], animal[1,2,4,5], and in human [1,2,6,7
Cham and Evans, unpublished data]. It has been demonstrated that specific endogenous lectins which are
present on the plasma membranes of susceptible cells recognize and bind the sugar moiety of the
solasodine glycosides [2,3]. The glycosides are subsequently internalised and cause cell death [2,3].
It was previously shown that a standard mixture of solasodine glycosides (BEC) [8] is effective in vivo
against murine S180 [1,2,4]. In such studies, BEC was injected in single and multiple doses upto 4 days
after administration of S180[4]. Rhamnose is not found in mammalian glycoconjugates but forms part of
solasonine, solamargine and diglycosides of solasodine in BEC. It was considered that specific receptors for
this sugar may be present on cancer cells (absolutely or in greater abundance) relative to normal cells. If
these receptors exist, rhamnose would be expected to inhibit the cytotoxic effects of BEC. Here we show
that rhamnose inhibits the efficacy of BEC, and that the aglycone solasodine is not effective against murine
S180.

It was previously shown that mice which were inoculated intraperitoneally with 5 x 10 S180 tumour cells all
died between days 12 and 20 after administration of S180 cells [4]. We now also demonstrate that mice in
their terminal stage with S180 can tolerate and become symptom-free of cancer by a large single dose of
BEC.The mice tolerate BEC at concentrations which are equivalent to 3 times the LD100 of control normal
mice.

Topical treatment of pre-malignant and malignant skin cancers with Curaderm-BEC5.
Drugs of Today, 1990
Curaderm-BEC5, a topical preparation of a mixture of solasodine glycosides (BEC) which are present in
some solanaceous plants, has become available to Australian practioners for the treatment of cutaneous
solar keratoses, basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs).

Topical treatment of pre-malignant and malignant skin cancers with Curaderm.
Cham, B. E., Daunter, B. (1990).
Drugs of Today 26, 55-58.

Introduction
To have a suntan has become fashionable in the last 60 years, and people have increasingly felt that
exposing their skin to the sun is a healthy, happy thing to do. However, the ultraviolet part of the
electromagnetic spectrum produced by the sun as light, in particular U.V.B (320-290nm), is responsible for
producing long term solar skin damage (keratosis) and skin cancers.
Curaderm, a topical preparation of a mixture of solasodine glycosides (BEC) which are present in some
solanaceous plants, has become available to Australian practioners for the treatment of cutaneous solar
keratoses, basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs). This review covers the
attributes of Curaderm within these concepts of pathogenesis and therapeutics.
Solasodine glycosides as Anti-cancer Agents. Pre-clinical and Clinical studies.

Asia Pacific Journal of Pharmacology, 1994
Solamargine a naturally occurring solasodine triglycoside binds to the EELs and this interaction intiates a
chain of events, resulting in the internalisation of solamargine with concomitant delivery of solasodine to the
targeted cell. Solamargine travels via the desmosomes to the lysosomes. The action of solamargine is
lysosomotropic (rupturing of the lysosomeThese events result in sudden cell death.

Solasodine glycosides as anti-cancer agents: Pre-clinical and Clinical studies.
Cham, B. E. (1994).
Asia Pacific Journal of Pharmacology. 9, 113-118.

Introduction
There is a resurgence in the interest of solasodine-containing species of Solanum. Previously most of the
interest of solasodine-bearing plants was due to their potential conversion to synthetic drugs. However,
more recently it was shown that some biological activity of the original glycosides is present. Certain
solasodine glycosides have been shown to have anti-cancer properties. The alkaloid solasodine on its own
does not appear to be antineoplastic.

The solasodine has to be conjugated to specific sugars in order to posses the anti-cancer properties. An
equally important observation was recently reported. Endogenous endocytic lectins (EELs) which are
endogenous sugar receptors have been biochemically characterized in tumours. There are qualitiative as
well as quantitative differences in histochemical patterns of certain carbohydrate binding proteins in tumours.
Solamargine a naturally occurring solasodine triglycoside binds to the EELs and this interaction intiates a
chain of events, resulting in the internalisation of solamargine with concomitant delivery of solasodine to the
targeted cell. Solamargine travels via the desmosomes to the lysosomes. The action of solamargine is
lysosomotropic (rupturing of the lysosome). These events result in sudden cell death.

The efficacy of solamargine for killing cancer cells depends on the specificity of receptors on these cells for
the recognition of solamargine. In this review, attention is drawn to solasodine glycosides and their actions
on cancer cell relative to normal cells.

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