CeNeS Announces Further Positive Results of its Phase II Clinical Trials of Morphine-6-glucuronide (M6G)
CAMBRIDGE, U.K., Nov. 15, 2002 (PRIMEZONE) -- CeNeS Pharmaceuticals plc (LSE: CEN.L - news) (LSE:CEN) (Other OTC:CPHAF) today announced additional positive results from its recent Phase II trial comparing the analgesic efficacy of morphine-6-glucuronide (M6G) with morphine. The study showed that patients undergoing hip replacement surgery obtained equivalent post-operative pain relief with M6G as with a standard regime of morphine. The study was carried out under the CeNeS/Elan Corporation, plc (NYSE:ELN) ("Elan") joint venture that was initiated in June 2001. M6G is now ready to enter its Phase III trial programme in Europe subject to regulatory approval.
M6G is a metabolite of morphine that exerts analgesic effects with a reduction in the nausea and vomiting associated with morphine therapy. The Phase II trial just completed was to establish that M6G was genuinely as effective in pain relief as equivalent doses of morphine. The 68 patients undergoing hip replacement surgery were divided into three groups: one group received M6G at induction of anaesthesia, the second group received M6G after surgery and the third group received morphine after surgery. Following these treatments, morphine was available to all patients for further pain management. The degree of analgesia conferred by the initial treatments was measured in two ways: using a pain rating scale and also by measuring the patient administered levels of morphine post-surgery. All three groups scored equivalent degrees of pain relief with no statistical differences, thus confirming that M6G was as effective as morphine in pain relief when administered both pre- and post-operatively. After either initial M6G treatment, but particularly following treatment with the higher dose of M6G, morphine consumption, nausea and retching/vomiting were lower than that following the initial treatment with morphine.
"We are very pleased with the positive results of M6G. The study proves that M6G is just as effective an analgesic agent as morphine in the treatment of post-operative pain. We remain positive on the potential market application for M6G as an analgesic with a better side effect profile than morphine," said Neil Clark, Chief Operating Officer and Financial Director of CeNeS.
M6G has undergone several Phase II clinical trials with more than 450 patients receiving M6G. The most recent Phase II trials were designed to establish the analgesic effects of different doses of M6G administered at different times compared to a standard morphine treatment regime. Phase III efficacy studies are currently being planned: a pivotal, dose-ranging placebo controlled study is scheduled to commence as a multi-centre study in Europe in early 2003 in patients undergoing knee replacement surgery with spinal anaesthesia. This will be followed by a second Phase III trial in Europe comparing M6G and morphine treatment in patients with postoperative pain following gastrointestinal and gynaecological surgery. Side-effect profiles of M6G will be investigated in both studies. If these trials are successful then M6G will be on target to be launched in Europe in 2005.
M6G is currently partnered with Elan under a joint venture arrangement. This arrangement has worked well to date and facilitated the further development of M6G. As previously announced, CeNeS has started discussions with its partner Elan to simplify the current joint venture. It is therefore expected that these later trials will be managed and funded outside of the joint venture. Further details will be announced in due course as the particulars of the new arrangements are finalised.
CeNeS is a biopharmaceutical company specialising in the development and commercialisation of drugs for pain control and CNS (NASDAQ: CNXS - news) disorders The company currently markets four products, and has research and development assets targeting pain and CNS disorders. The company is based in Cambridge, England. For further information visit www.cenes.co.uk. |
