Projects Profile
Project Title
Pharmaceutical and commercial development of a purified phytochemical extract from the Chinese fungus, Ganoderma lucidum for use in prostate cancer chemoprevention
Partnership
Prof. Sue Watson & Professor Ken Muir from The University of Nottingham
Prof. Prof De-An Guo from Chinese Academy of Sciences
Project Aim
The major aim of the project is to further develop a uniquely-isolated triterpene extract from GL, in which pre-clinical efficacy has been confirmed, for clinical use in prostate cancer chemoprevention where current approaches remain untested or are associated with side-effects.
This project will further develop the manufacturing process for the triterpene extract to support completion of the pre-clinical phase and to define the programme of studies to complete the safety pharmacology. It will also strengthen/exemplify current intellectual property (IP) including new applications and technology advances and establish the regulatory and clinical strategies for submission of clinical trial authorisation (CTA) in the UK.
Inspiration for the projects
Ganoderma lucidum, [GL], a medicinal fungus, has been used for many centuries in China as a medical aid in malignant conditions. Through a collaboration with Professor Guo at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, a purified component has been identified which exerts strong inhibitory activity against both prostate cancer and pre-malignant prostate cells (prostate intra-epithelial neoplasia, PIN).
This opens up the opportunity of using this preparation as a nutriceutical in the diet of men who have evidence of pre-malignant change within their prostate to prevent progression to full blown cancer. Hence, based on the high incidence of prostate cancer in the West and the trend to an increased incidence in China this would offer a major health advance in cancer prevention and management.
Innovation Elements
The innovation of this project is the development of a uniquely-isolated triterpene extract from GL for clinical use in prostate cancer chemoprevention where current approaches remain untested or are associated with side-effects.
Commercial Potential and Further Development
Prostate cancer is now the most common form of cancer in men in the UK with 35,000 new cases diagnosed each year (Cancer Research UK, 2004) and the annual cost of treatment in England and Wales approximately £100m.
PIN appears to precede cancer by more than 10 years, affecting 40% of men in their fourth decade, with a parallel age-related increase in the frequency of PIN and cancer; in men over 80 years of age the prevalence of PIN is 70%. The use of GL to inhibit the progression from PIN to prostrate cancer could impact upon cancer associated mortality and reduce treatment costs.
46% of the UK population use complimentary/alternative medicine which is a growing trend based on provision to fulfil identifiable needs currently unmet. Such approaches need to fit with conventional medical practices. This ICUK project will help provide a model prototype in TCM integration into European Clinical directive practices adding to existing good practice derived for use of TCM in angiogenic and malaria applications.
