Friday, July 30, 2010
CeNeS - Update on M6G
Cambridge, UK, 6th December 2007 - CeNeS Pharmaceuticals plc (LSE: CEN), the Cambridge based biopharmaceutical company, today provides an update on the development of its lead programme, M6G. Following on from the successful Phase III results earlier this year the Company has now completed preparations for the Phase III programme in the US:
1. The IND-opening Phase I pharmacokinetic study (M6G029) has been completed. The anticipated favourable profile of linear pharmacokinetics with minimal drug accumulation on repeat dosing was observed.
2. The Phase I metabolism study (M6G023) has been completed. The data generated support the anticipated differentiation of M6G from morphine, i.e. little or no metabolism and excretion as unmodified M6G by the kidneys.
3. The last renally impaired volunteer has now entered the Phase I renal-impairment study (M6G024).
4. The additional pre-clinical studies required by the FDA have been completed.
5. With the conclusion of the above, CeNeS has completed the studies requested by the FDA to support a Phase III programme in the
6. The partnering process for M6G is ongoing and CeNeS expects to announce a licensing deal in 2008. It is anticipated that the deal terms will provide for an initial up f
Neil Clark, Chief Executive of CeNeS, said:
“I am very pleased to report that all the studies required to allow commencement of a US Phase III programme for M6G either have now either been completed or will shortly be so. We are active in the partnering process and continue to have discussions with potential partners to collaborate and fund this programme through to product launch. These recent studies will assist us in this process by further strengthening the package of data available for potential partners.
In addition, the Board has noted the recent share price movement and confirm that they know of no reason for the recent decline. The Company has sufficient working capital and continues to make good progress in all areas of its operations. The CNS 5161 cancer pain Phase II trial is ongoing and we are progressing to plan with the completion of the pre-clinical development of CNS 7056 our short acting sedative/anaesthetic that is partnered for Japan with Ono Pharmaceuticals. “
For more information please contact:
CeNeS Pharmaceuticals plc
Neil Clark, CEO
Tel: +44 (0)1223 266 466
JM Finn Capital Markets
Geoff Nash
Tel: +44 (0)20 7600 1658
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
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. Post-operative nausea and vomiting 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, sedation 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 but shows a reduced incidence of nausea and vomiting and sedation 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%.
Published: 6th Dec 2007 - 08:41:17
Modified: 6th Dec 2007 - 08:51:18
