FDA approves IND on Lead Product M6G
CAMBRIDGE, England, 26th April 2007 - CeNeS Pharmaceuticals plc (LSE: CEN), the Cambridge based biopharmaceutical company, today announces that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the clinical development of morphine-6-glucuronide (M6G), its novel drug for the treatment of post-operative pain. Earlier this year, CeNeS announced results of a Phase III study of M6G in Europe in over 500 patients with post-operative pain. The study demonstrated that M6G provided equivalent pain relief to morphine but induced significantly less post-operative nausea and vomiting (PONV). The opening trial under this IND will be a Phase I pharmacokinetic study in volunteers. This study is required by the FDA as is an additional pre-clinical toxicology analysis before progressing to Phase III trials. CeNeS is currently completing the protocol design of the first US Phase III trial. The filing of the IND enhances the package of data already available to potential US partners for review. Neil Clark, Chief Executive of CeNeS, said:
"The FDA's approval of our IND application for M6G is a major landmark in CeNeS' clinical development programme. North America is an attractive market for our drug candidate and M6G is clearly positioned to be a genuine alternative to standard morphine therapy."
For more information please contact: CeNeS Pharmaceuticals plc Neil Clark, CEO Tel: +44 (0)1223 266 466
JM Finn Geoff Nash Tel: +44(0) 207 628 9688
Financial Dynamics Ben Brewerton/Emma Thompson Tel: + 44 (0) 207 831 3113
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 M6G Morphine formulations are the gold standard treatment for the relief of moderate to severe post-operative pain. A limitation of morphine treatment is often the unpleasant side effects experienced, of which nausea and vomiting are the most common. PONV is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life.
The active potent metabolite of morphine, morphine-6-glucuronide (M6G), may offer therapeutic advantages over morphine in having an equivalent analgesic effect, but with a reduced tendency to cause nausea, vomiting and respiratory depression. Phase II and III clinical trials have shown that M6G given intravenously produces equivalent analgesia to morphine to combat post-operative pain. Studies have also shown that M6G reduced the incidence of nausea and vomiting when compared directly with morphine. Other studies published recently in the scientific literature demonstrate that M6G also reduces respiratory depression compared to morphine.
The global market for opiate use in managing post-operative pain was estimated at $1 billion in 2000 and growing at a rate of 6-7%.
Posted: April 2007
