Clinical data on CeNeS potential treatment for diabetic neuropathic pain to be presented at European Association for the Study of Diabetes (EASD) conference

Cambridge, UK, 15 September 2006 - CeNeS Pharmaceuticals plc (AIM: CEN), the Cambridge based biopharmaceutical company, today announced that a presentation will be given tomorrow on the CeNeS compound CNS 5161 at the 42nd EASD Annual Meeting being held in Copenhagen, Denmark from 14-17 September. The presentation* will be made by Dr Thomas Forst, the lead investigator on the successful Phase IIa study of CNS 5161 that completed in June 2005.
The presentation sets out analysis of the data supporting the view that the first proof of concept (Phase IIa) results announced last year indicated an analgesic effect of CNS 5161 especially in patients with diabetic neuropathic pain.
Further, larger studies planned for 2007 will investigate the clinical effects of CNS 5161 in diabetic neuropathic pain patients. CeNeS and its partner Ergomed plan to complete a double-blind, 3-way cross-over, acute study to compare the efficacy and safety of two doses of CNS 5161 (250μg and 500μg) and placebo in 75 diabetic neuropathy patients with chronic, intractable neuropathic pain.
Diabetic neuropathic pain is a condition which is increasing in prevalence in line with the increase in the incidence of diabetes. It is estimated that half of diabetic sufferers develop some form of neuropathic pain. This pain is currently poorly treated. Drug treatments for neuropathic pain represent a significant area of unmet medical need and a growing market opportunity that is currently valued at over $2 billion globally.
Neil Clark, Chief Executive of CeNeS, said, “We are very pleased that data on our Phase II compound is being presented at this major diabetes conference and we look forward to the further testing of CNS 5161 in Phase II trials next year. If successful, these trials will be a significant step forward for patients in need of an effective treatment for this difficult condition.”
*Abstract Title: “Safety and efficacy of CNS 5161, a new neuronal glutamate receptor antagonist (NMDA) in the treatment of painful peripheral neuropathy”

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About CeNeS Pharmaceuticals
CeNeS is a biopharmaceutical company specialising in the development and commercialisation of drugs for pain control, sedation and other CNS disorders such as Parkinson’s disease. The company is based in Cambridge, England.
For further information visit the CeNeS web site: www.cenes.com

About CNS 5161
A range of primary diseases or conditions such as diabetes, cancer, HIV/Aids and shingles, or surgical procedures such as limb amputation can result in nerve damage which leads to a sustained chronic pain. This neuropathic pain is difficult to treat as traditional analgesics do not provide adequate relief for many patients. Drug treatments for neuropathic pain represent a significant area of unmet medical need and a growing market opportunity that is currently valued at over $2 billion globally.
Glutamate (particularly NMDA) receptors have been implicated in the induction and maintenance of neuropathic pain and NMDA antagonists may represent a class of drugs for effective relief of neuropathic pain.
CNS 5161 is a blocker of the NMDA ion channel and has completed Phase I and more recently Phase IIa proof of concept clinical trials as a novel compound for the treatment of neuropathic pain.
Two Phase I studies using CNS 5161 administered intravenously have been completed in male volunteers. The first study demonstrated the safety and tolerability of selected doses of CNS 5161 and the second that at a dose of CNS 5161 that was well tolerated, analgesic effects were evident in an experimental model of pain.
Two phase IIa studies have been completed giving single dose intravenous infusions of CNS 5161 to patients with long standing intractable neuropathic pain. A total of 48 patients have received CNS 5161; 10 patients in an initial study and 38 patients in a study completed in 2005. Both studies reported analgesic effects of CNS 5161 at doses that were well tolerated by the patients.

Contact Information

Neil Clark

CEO

CeNeS Pharmaceuticals plc

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