SOURCE: CeNeS Pharmaceuticals Plc

June 08, 2005 02:00 ET

CeNeS Pharmaceutical announces Clinical Trial Results

Cambridge, UK -- (MARKET WIRE) -- June 8, 2005 --

     CeNeS announces successful results from its Phase IIa clinical 
                trial of CNS 5161 in neuropathic pain

Cambridge, UK, 8th June 2005 - CeNeS Pharmaceuticals plc (AIM: CEN) 
("CeNeS" or "the Company") today announced successful results from its 
Phase IIa proof of concept study of CNS 5161, its potent and selective 
NMDA antagonist, in neuropathic pain. In the study, which was designed to 
establish the therapeutic window of CNS 5161, the product was associated 
with a clear trend to improvement in pain levels and was well tolerated 
with no instances of the psychotomimetic side effects associated with 
some NMDA antagonists.

The Phase IIa study was a 48-patient, European multi-centre, double blind,
cross-over, dose escalating, preliminary safety and efficacy study, 
comparing a single dose of CNS 5161 to placebo in order to establish a 
maximum tolerated dose of CNS 5161. Intractable chronic neuropathic pain 
patients of varied aetiology (such as diabetic neuropathy and post-
traumatic neuropathy) were investigated in the study. Four escalating 
dose levels (125, 250, 500 and 750 ug) of CNS 5161 were planned to be 
administered by intravenous infusion over six hours, with study 
continuation to each higher dose subject to a satisfactory safety review 
after each cohort of 12 patients had been completed. Recruitment to the 
final cohort (750ug) was not completed due to hypertensive events (high
blood pressure), an expected outcome at higher doses. There were no
psychotomimetic side effects with CNS 5161, an important finding as such 
events have been associated with some NMDA antagonists, causing them to 
be dropped from development. This latter finding confirms CeNeS 
understanding that CNS 5161 occupies a unique position in its class.

In terms of pain relief, the study showed that 500ug of CNS 5161 was 
associated with a clear trend to improvements in pain levels (measured 
using a Visual Analogue Scale (VAS) ) at two, six and twelve hours after 
the start of the intravenous infusion, when compared to placebo. The 
results were not statistically significant as may be expected with small 
group sizes (12 patients per dose group) in a proof of concept study. The 
analgesic effects of CNS 5161, however, appeared to be demonstrated 
predominantly in the group of patients with diabetic neuropathy. Further 
analysis of the data will be carried out to nvestigate the apparent 
selectivity of CNS 5161 activity to the diabetic neuropathy group. 
Compared to placebo, the lowest dose of 125ug showed no effect on pain 
scores whilst the 250ug dose showed an improvement in pain scores that 
was most evident at 24 hours. This latter observation supports previous 
clinical indings with this compound. At all dose levels, CNS 5161 was 
well tolerated and demonstrated a safety profile similar to that observed 
in earlier clinical studies.

Neil Clark, CEO of CeNeS, said "CeNeS is very pleased that this proof of 
concept dose escalating study has successfully established a therapeutic 
window for the use of CNS 5161 as a potential treatment for neuropathic 
pain - a serious chronic condition which is poorly treated at present. 
CeNeS will continue to analyse the data from this and previous studies in 
order to plan the next steps in the clinical development of this 


For more information please contact:

CeNeS Pharmaceuticals plc
Neil Clark
Tel: +44 (0)1223 266466

Northbank Communications
Emma Palmer (financial enquiries)
Douglas Pretsell (media enquiries)
Rowan Minnion
Tel: +44 (0)20 7886 8150

This news release contains forward-looking statements that reflect the 
Company's current expectation regarding future events. Forward-looking 
statements involve risks and uncertainties. Actual events could differ 
materially from those projected herein and depend on a number of factors 
including the success of the Company's research strategy, the 
applicability of the discoveries made therein, the successful and timely 
completion of clinical studies and the uncertainties related to the 
regulatory process.

Notes to Editors:

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:

About CNS 5161 - for the treatment of neuropathic pain

Neuropathic pain represents a significant unmet medical need and a large,
growing market opportunity currently worth over $2billion globally. It 
arises from a range of primary diseases or conditions (including cancer, 
diabetes, shingles and HIV/AIDS) that can result in nerve damage and 
subsequently chronic pain. Neuropathic pain is difficult to treat and 
current analgesics do not provide adequate relief for many patients. 
This "neuropathic pain" can be described by patients as burning, 
stinging, shooting, aching or electric-shock-like sensations, and it can 
last for many months or years. Common features of these abnormal 
conditions include increased temporal summation of pain in response to 
repeated stimulation ("wind-up" pain), hyperalgesia (reduced pain 
threshold and exaggerated response to mild noxious stimuli), and allodynia
(painful response to non-noxious stimuli). Drug treatments for 
neuropathic pain represent a significant area of unmet medical need and a 
growing market opportunity.

One of the most common forms of neuropathic pain is associated with 
diabetes. It is estimated that there are over 13 million patients in the 
USA and Europe with diabetes and that over 30% of these experience 
neuropathic pain, which can last for many years. In addition, herpes 
zoster infections can lead to shingles and up to 20% of the 1.5 to 2 
million patients in USA and Europe with shingles experience neuropathic 
pain, which is often resistant to current treatments and can last for 
many months.

Research studies have previously shown that glutamate (particularly NMDA)
receptors are implicated in the induction and maintenance of neuropathic 
pain and NMDA antagonists have been shown to be effective in models of 
persistent pain. CNS 5161 is a potent and selective NMDA antagonist.

CeNeS has completed two Phase I studies with CNS 5161 for the potential
treatment of neuropathic pain.  The first study demonstrated the safety 
and tolerability of selected doses of CNS 5161 given intravenously. The 
second study examined the reduction in pain experienced after placebo, 
morphine and two separate doses of CNS 5161 (0.25mg and 0.5mg), were 
administered on separate occasions to sixteen volunteers. CNS 5161 at 
0.5mg was found to produce a statistically significant reduction in 
perceived pain compared to either morphine or placebo and notably with 
minimal side effects.

In 2002 CeNeS completed an initial Phase IIa study in 10 patients with 
chronic neuropathic pain. This study further demonstrated that CNS 5161 
gave statistically significant pain relief over 24 hours following a 6 
hour intravenous infusion of 0.25mg of the drug. The drug was well 
tolerated by the patients with no significant side effects.

The recently completed Phase IIa study was a multi-centre, randomised, 
double blind, placebo controlled crossover study in mixed neuropathic 
pain patients including those with:

   -  diabetic neuropathy
   -  post-traumatic nerve injury
   -  post-herpetic neuralgia
   -  chronic regional pain syndromes I and II

All patients in the study had been diagnosed with chronic (> 6months)
neuropathic pain (VAS > 3.5).

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