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BTG Initiates Clinical Study of Novel Multiple Sclerosis Treatment 06 March 2008

BTG plc, the life sciences company, announces that dosing has commenced in a Phase I clinical study of BGC20-0134, a potential treatment for multiple sclerosis.

The randomised, double-blind, placebo-controlled study will assess the pharmacodynamic, pharmacokinetic and safety profiles of single and multiple oral doses of BGC20-0134 in healthy volunteers.


Louise Makin, BTG's chief executive officer, commented: "The effective treatment of multiple sclerosis remains a significant unmet need. We are pleased to have started clinical development of BGC20-0134, which has the potential to address different forms of the disease and has the advantage of being an oral product."


Although the cause of multiple sclerosis is unknown, there is strong evidence that autoimmune mechanisms are involved in its development. T-cell infiltration into the central nervous system and resultant dysregulation of key pro-inflammatory cytokines leads to myelin loss, neuronal damage and the onset of symptoms and disability. BGC20-0134 is a novel structured lipid designed to restore the balance between pro-inflammatory (e.g. IL-1b and TNFá) and anti-inflammatory (e.g. TGFb1) cytokines.


In a pilot study of a prototype compound, patients with the relapsing-remitting form of multiple sclerosis experienced clinical benefits including decreases in both relapse rates and EDSS scores (a standard measure of disability in multiple sclerosis), together with improvements in pain and cognitive endpoints. In preclinical models of multiple sclerosis, the potency of BGC20-0134 was shown to be three times that of the prototype compound.

Source: BTG Ltd (06/03/08)

Another article about this drug:

Potential Treatment For Multiple Sclerosis Begins Clinical Trials 14 April 2008

A potential treatment for multiple sclerosis (MS), developed by University of Greenwich in association with Kings College, London, has begun clinical trials.

The life sciences company BTG plc, which has licensed the research, is running the trials on a new compound, known as BGC20-0134.

Dr Laurence Harbige and Dr Mike Leach, from the Biomedical & Drug Discovery Research Group in the University of Greenwich School of Science, developed the new treatment following many years of research.

Dr Laurence Harbige explains: "Although the cause of multiple sclerosis is unknown, there is strong evidence that it involves the regulation of the immune system through molecules in our bodies called cytokines. In MS, the balance of these cytokines is altered, leading to inflammation in the brain which can result in serious disability."

Dr Mike Leach adds: "This new treatment should encourage the immune system to rebalance itself, by inhibiting the production of inflammatory cytokines while promoting the production of helpful anti-inflammatory ones."

These initial trials, in volunteers, will look at how the new treatment works in the body and whether it leads to an increase in the helpful cytokines. A pilot study of a prototype treatment developed by the University of Greenwich team, which is related to this compound, has already shown promising results. It demonstrated clinical benefits in patients with a common form of multiple sclerosis, called relapsing-remitting. It led to decreases in relapse rates, disability and pain, along with improvements in quality of life. Preclinical research on the new compound, BGC20-0134, indicates that it may be three times as potent as this prototype.

Professor Tom Barnes, Pro Vice-Chancellor for Research & Enterprise at the University of Greenwich, congratulates the team behind the discovery: "It is very good news that this research is now in clinical trials. Our university aims to carry out work which is useful to society and this discovery is a classic example of that. It highlights the excellence of the research staff at Greenwich and also the business orientation of the university, through this partnership with BTG plc. Drs Harbige and Leach are to be congratulated on this important milestone."

Louise Makin, BTG's Chief Executive Officer, comments: "The effective treatment of multiple sclerosis remains a significant unmet need. We are pleased to have started clinical development of BGC20-0134, which has the potential to address different forms of the disease and has the advantage of being an oral product."

Source: Medical News Today © 2008 MediLexicon International Ltd (14/04/08)