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" Curaderm and Basal Cell Carcinoma (BCC) "


Introduction

Curaderm is in a tube of 15ml containing 0.005% mixture of Solasodine Glycosides. Solasodine is a steroid alkaloid. Curaderm is a standardized mixture of two triglycosides, Solasonine and Solamargine and their corresponding DI- and monoglycosides. Urea and salicylic acid are included in the cream as keratolytic to enhance the penetration of Curaderm into the tumor and to aid the removal of dead tissues. It is intended for twice daily application to the lesion until complete eradication.

Curacleanse Antiseptic Gel 50 ML
&
Curaderm Cream 15 ML

Curaderm Data
Literature Exclusive For Physicians


History

As far back as 1825 it was reported that extracts of the plant species Solanum were effective in treating cancers. It has now been established that the anti-neoplastic compounds in these extracts were glycoalkaloids.

In the early eighties, an Australian biochemist, Dr. Bill Cham, observed that a number of cattlemen in the Brisbane, Queensland, area were using the juice of a naturally growing plant called locally “ Devil ’s Apple ” (Solanum Sodomaeum) to cure cancer that had developed around the eyes of some of their cattle. Dr. Cham and his fellow scientists isolated Solasodine and applied it to cancer cells in a laboratory environment. They looked at various types of cancer including ovarian, lung, breast and skin and the effects of Solasodine. The results were very encouraging in all areas, however as Australia has the highest incidence of Skin Cancer and solar Keratosis (pre-skin cancer) in the world, Dr. Cham elected to continue the work in this area. After years of research, he developed a commercial product called Curaderm. Curaderm, was approved for the treatment of Actinic Keratosis by the Therapeutics Goods Administration (TGA) in 1991 in Australia.

Regulatory

In 1996 an application to have a pre-IND meeting with the United States Food and Drug Administration (FDA) was filed and allowed. At this meeting FDA informed that once the IND had been granted this application would be put in what FDA calls “ fast track “. FDA did have some questions regarding two of the ingredients in the product Curaderm and indicated that two extra arms would be required during the clinical trial due to these two ingredients out of the product and by so doing had to re-engineer the active ingredient, thereby creating a new product that we call BEC-5.

In February 1997 the Medicines Control Agency (MCA) in the UK granted a Clinical Trial Exemption (CTX). Soon thereafter a multi-centre double blind phase III clinical efficacy trial was carried out by PPD Pharmaco in the UK and this trial has established the product to be significantly superior to placebo in the treatment of BCC.

Skin Cancer

There are three primary types of skin cancer: Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) and Melanoma. BCC and SCC, the most common forms, are often grouped as non-melanoma skin cancer; they account for about one million new cases of skin cancer each year in the USA and approximately 800,000 new cases in the European Union. It is estimated that approximately 40,000 people in the USA will develop melanoma this year, approximately this same amount applies to the European Union. BCC is the most common form of skin cancer, affecting approximately 900,000 Americans each year. In fact, it is the most common of all cancers. One out of every three new cancers is a skin cancer, and the vast majority is Basal Cell Carcinoma.

Actinic Keratosis is a pre-cancer. About one in six Americans and one in eight Europeans will develop at least one actinic Keratosis at some time. In fact, one of four people who attend the American Academy of Dermatology Skin Cancer screenings, have at least one actinic Keratosis

Treatment goals focus on complete tumor disappearance and minimization of cosmetic and functional defects. The most commonly used therapies are lectrodesiccation, curettage, excision, and cryosurgery. Curaderm has been found to have the following significant advantages over more traditional of conventional methods of treatment of skin cancer:

  • The product has durability in terms of cure rate
  • It is non invasive compared to surgery
  • It is significantly more cost effective
  • There is no or minimal scarring compared to surgery

    Competition

    Several methods are available for the treatment of basal cell carcinoma, including chemotherapy, cryotherapy, irradiation, topical 5-FU and several forms of surgery. Several of these techniques require hospitalization, even if only as a day case, and inevitably leave scars. Most recurrences in basal cell carcinoma occur in the first 18 months after surgery.

    The location, type of lesion, and experience of the physician helps to determine the form of treatment. Curaderm cream is a new topical treatment whose potential benefits include the possibility of a better cosmetic outcome than with surgical treatment.

    The nature of the affliction will demand a cost-effective method of treatment. Currently surgery is one of the options and although most of the surgery is done on an outpatient basis, the cost of surgery can be prohibitive and efficacy is questionable. To the best of our knowledge ,the only other topical treatment for actinic Keratosis is 5-FU chemotherapy (Efudex).

  • The following contains some "before and after " treatment photographs.

    Nose Lesion

    Arm Lesion
    IMPORTANT DISCLAIMER The product list included on this site is intended for information purposes only. Products listed above are for distribution outside of the USA & Canada. All products listed are available upon prescription from a medical doctor in the country of distribution. The product list is not intended to provide complete medical information. Patients should always obtain complete medical information about their prescription medicines (beneficial medical uses and possible adverse effects) from the product's information leaflet and/or by discussing the appropriate use of any medicine(s) directly with their prescribing physician.
    Curacel Institute of Medical Research
    The Curacel Institute of Medical Research is a non-profitable subsidiary of Curacel International and is actively engaged in cancer and cardiovascular research. Some of its research is already being applied to clinical practice. Unlike many similar institutes that rely on donations from organizations and the public, Curacel International are proud to donate some proceeds from the sale of products to the Curacel Institute of Medical Research.
    References
    Cham BE and Wilson L. HPLC of glycoalkaloids in Solanum sodomaeum L. Planta Medica 1987; 53: 59-61.
    Cham BE. Monograph on the compound BEC. Drugs of the Future 1988; 13: 714-716.
    Cham BE and Daunter B. Topical treatment of pre-malignant and malignant skin cancers with Curaderm. Drugs of the Future 1990; 26: 55-58.
    Daunter B, Cham BE. Solasodine glycosides. In vitro preferential cytotoxicity for human cancer cells. Cancer Letters 1990; 55: 209-220.
    Cham BE. Solasodine glycosides as anti-cancer agents: preclinical and clinical studies. 2 nd World Congress on Cancer 1995 Sydney, Australia pp 111-114.
    Cham BE and Daunter B. Solasodine glycosides. Selective cytotoxicity for cancer cells and inhibition of cytotoxicity by rhamnose in mice with sarcoma 180. Cancer Letters 1990; 55: 221-225.
    Nakamura T, Komori C, Lee Y, Hashimoto F, Yahara S, Nohara T and Ejima A. Cytotoxic activities of Solanum steroidal glycosides. Biol. Pharm. Bull. 1996; 19: 564-566.
    Cham BE, Gilliver M and Wilson L. Antitumour effects of glycoalkaloids isolated from solanum sodomaeum. Planta Medica 1987; 53: 34-36.
    Cham BE and Meares HM. Glycoalkaloids from solanum sodomaeum are effective in the treatment of skin cancers in man. Cancer Letters 1987; 36: 111-118.
    Cham BE, Daunter B and Evans RA. Topical treatment of a malignant and premalignant skin lesions by very low concentrations of a standard mixture (BEC) of solasodine glycosides. Cancer Letters 1991; 59: 183–192.
    Cham BE. Solasodine glycosides as anti-cancer agents: Pre-clinical and clinical studies (Review Article). Asia Pacif. J. Pharmacol. 1994; 9: 113-118.
    Williams, DG. The skin cancer cure nobody wants you to know about. Alternatives 1995; 6: 17-22.
    Moss RW. Curaderm (Australia). Herbs against cancer. Equinox Press 1998, pp 179-182.
    Literature Resources

    Herbs Against Cancer: History and Controversy
    by Ralph W. Moss PhD

    Chapter 12, Page 179
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    Product was developed by Dr. B. Cham in Australia. Bec-5 / Curaderm is a cream formulation containing high concentrations of a standard mixture of solasodine glycosides which has been shown to be effective in the treatment of malignant and benign human skin cancers: basal cell carcinoma, squamous cell carcinoma and actinic Keratosis. A formulation known as Curaderm developed by Dr. B Cham has been approved by the Australian Health Authorities, the Health Department of the Netherlands Antilles and is going through the procedures for approval in the European Union and the USA. A double-blind multi-centre clinical trial conducted in England achieved a 78% success rate on basal cell carcinoma.