Posted by: Thixia | March 8, 2008

drug study of single and multiple oral doses

Clinical Study of Novel Multiple Sclerosis Treatment

Dosing has commenced in a Phase I clinical study of 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 in healthy volunteers.

“The effective treatment of multiple sclerosis remains a significant unmet need. We are pleased to have started clinical development, 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. This drug 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, this drug was shown to be three times that of the prototype compound.

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