BioWorld International Correspondent

LONDON - CeNeS Pharmaceuticals plc announced positive interim results from Phase II trials of CNS5161, an ion channel blocker for the treatment of neuropathic pain, and said it would go ahead with a multicenter Phase II proof-of-concept trial.

At the same time, CeNeS said the recent identification of a risk gene for schizophrenia has positive implications for its compound, rhGGF2 (glial growth factor 2), which has reached late-stage preclinical development for the treatment of multiple sclerosis. rhGGF2 is a recombinant version of the protein coded by the neuregulin-1 gene, which a team of researchers led by Hans Moises at the University of Kiel, Germany, announced on March 27 is associated with schizophrenia.

Neil Clark, chief operating officer and financial director of Cambridge-based CeNeS, said the company would complete the multicenter trial of CNS5161 before partnering it. "We would, of course, be pragmatic. There is always a lot of interest around neuropathic pain, but we expect to complete this study before we find a partner."

In the Phase II results released last week, a single cohort of 10 patients who received a 0.25-mg infusion of CNS5161 administered intravenously over six hours experienced statistically significant pain relief. The drug is designed to prevent the overactivation of the glutamate receptor that is implicated in neuropathic pain.

Clark said there is proof of principle for a patch formulation as an alternative method of delivering the drug.

CeNeS said its collaboration with Elan Corp. plc, of Dublin, Ireland, for the development of the morphine metabolite M6G for the treatment of moderate to severe pain, is progressing well. Results of a Phase II study in patients following hip replacement surgery are due in the third quarter, with Phase III trials expected to start in 2003.

The news that the neuroregulin-1 gene is linked to schizophrenia may revive the fortunes of rhGGF2, whose development was halted last year when a cash crisis forced CeNeS to restructure.

"This is one of our noncore assets and we are talking to interested parties [about a licensing deal]. Development to date has focused on multiple sclerosis, but we have had approaches since the schizophrenia paper was published," Clark said.

GGF2 stimulates the growth and differentiation of glial cells that form the myelin sheath insulating nerve cells. The compound was developed by Bayer AG in collaboration with Cambridge Neuroscience Inc., which was acquired by CeNeS in December 2000, and CeNeS owns all the rights to rhGGF2.

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