BEC- 5 Data
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TRADE NAME: :BEC-5

FORMULA AND PHARMACEUTICAL DOSAGE FORM:

Contains:
(Solasodine glycosides) Anti-neoplastic Cream.

Manufacturer: Open

Introduction

BEC-5 is for the treatment of Basal Cell Carcinoma (BCC).

BEC-5 is a cream containing 0.005% mixture of Solasodine Glycosides. Solasodine is a steroid alkaloid. BEC 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 BEC into the tumor and to aid the removal of dead tissues. It is intended for twice daily application to the lesion until complete eradication.

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 licensed as a Prescription Only Medicine 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 quastions regarding two of the ingredients in the productCuraderm 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. BEC-5 has been found to have the following significant advantages over more traditional of conventional methods of treatment of skin cancer: