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Biotech / Medical : CNSI Cambridge Neuroscience -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (616)	1/26/2001 8:09:32 PM
From: smh	Read Replies (1) \| Respond to of 675

CeNeS Pharmaceuticals : Positive Phase II clinical trial results for M6G - a morphine alternative; Clinical trials in over 140 post-operative pain patients show that CeNeS' drug has a competitive edge over morphine by reducing by more than 50% the 1/26/2001 JAN 26, 2001, M2 Communications - CeNeS Pharmaceuticals plc ("CeNeS" LSE:CEN.L) today announces results of a Phase II clinical trial directly comparing M6G with morphine in post-operative pain. The data confirmed that M6G has an equivalent analgesic effect as morphine combined with a better side effect profile, specifically a significant reduction in the frequency and severity of nausea and vomiting. Nausea and vomiting are the most common side effects of the use of morphine-like drugs, placing additional financial burden upon the health authorities through patient need for anti-emetic medication and longer hospital stays. Reducing their incidence by more than half will limit these additional costs and make a compelling pharmaco-economic argument for CeNeS' M6G drug to ultimately replace morphine for post-operative pain. CeNeS is currently conducting a parallel clinical trial comparing M6G with morphine to relieve pain after hip-replacement surgery. The trial began in June 2000 and is scheduled for completion in early 2001. M6G is a natural metabolite of morphine and as such represents a lower risk development candidate in CeNeS broad portfolio of pharmaceutical products and drug candidates for the treatment of different forms of pain. The data shows M6G's potential to compete strongly in the GBP1 billion global market for opioid analgesics. Daniel Roach, chief executive of CeNeS, comments: "These are excellent results and will further support our ongoing negotiations with a number of partners for the final development and commercialisation of M6G, a product which we believe could reach peak global sales of GBP100m." About CeNeS CeNeS Pharmaceuticals is focused on developing drugs for CNS disorders and pain control and the development of controlled release drug delivery products in a range of therapeutic areas. The group has around l30 staff working from modern research and manufacturing facilities in Cambridge, England, Irvine in Scotland and Boston, USA. CeNeS has considerable interest in this field. It already markets Diconal and Valoid for the treatment of severe pain in the UK and has developed Moraxen, an innovative formulation of morphine marketed by Schwarz Pharma in the UK and in final stages of development in Europe and the USA by Bioglan Pharma and Amarin Pharmaceuticals respectively. CeNeS has also recently licensed Xefo from Nycomed Pharma. Xefo will be launched in the UK in 2001 and is a novel analgesic for the treatment of post-operative pain. In its development portfolio, in addition to M6G, CeNeS has; -- CNS 5161, an NMDA antagonist in Phase II clinical trials for the neuropathic pain, -- CEE 04 440, a sublingual formulation of an opioid analgesic to address breakthrough pain in collaboration with Bioglan Pharma, -- a series of novel peptide drugs in preparation for Phase I clinical trials -- research programs exploring ion channel modulators in the treatment of pain. For more information, visit CeNeS' website at www.cenes.com About the Clinical Trial -- The primary aim of the trial was to investigate the incidence and severity of nausea following M6G administration compared with morphine sulphate in day care surgery patients. -- Twenty patients in the M6G group (29%) reported at least one episode of nausea following administration of the drug compared to 46 patients in the morphine group (70%). -- The study showed no significant difference between the two groups with regard to total pain intensity. -- The following secondary safety variables also showed significant differences between the groups in favour of M6G; total degree of nausea, episodes of nausea after discharge, number of patients who were treated with an anti-emetic drug during the day of surgery, the total degree of sedation during the first two hours. -- The study measured the use of anti-emetics and showed a significantly reduced requirement in the M6G treatment groups.