LONDON, March 6, 2008- BTG plc (LSE: BGC), 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
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.