January 21, 2010
BTG Commences Phase IIa Study of Pleneva™ for Multiple Sclerosis

London, UK, 21 January 2010

BTG plc (LSE: BGC), the specialty pharmaceuticals company, today announces that dosing has commenced in a European multicentre Phase IIa study of Pleneva™ (formerly BGC20-0134), a novel orally administered compound under development as a potential treatment for multiple sclerosis (MS).

Pleneva™ is designed to restore the balance between pro-inflammatory and anti-inflammatory cytokines in patients with MS. The study, in 166 patients with the relapsing-remitting (RRMS) form of the disease, comprises an initial 24 week double-blind, placebo-controlled dosing period followed by a 24 week open-label extension. The primary endpoint of the study is a reduction in the number of new T1 gadolinium enhanced lesions on MRI at weeks 12, 16, 20 and 24 when compared to placebo. A number of MRI and clinical secondary endpoints will further evaluate the safety and efficacy of the drug candidate.

Pleneva™ has completed a Phase I pharmacodynamic multiple ascending dose study in healthy volunteers which demonstrated that it was very well tolerated at all doses.

Louise Makin, BTG’s CEO, commented: “We are pleased to initiate the first study of Pleneva™ in MS patients. As a novel, oral compound designed to rebalance the levels of pro- and anti-inflammatory cytokines implicated in MS, Pleneva™ offers the potential of a new treatment option for this chronic, often debilitating condition.”

MS is a chronic disorder affecting movement, sensation and bodily functions and is characterised by destruction of the myelin insulation covering nerve fibres (neurons) in the central nervous system. MS is one of the most common neurological disorders and causes of disability of young adults, especially in Europe and North America. The majority of patients (~80%) are diagnosed with RRMS. The cause is unknown, but there is strong evidence for the involvement of the immune system in the development of the disease.

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Financial Dynamics
Ben Atwell
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