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CeNeS Pharmaceuticals plc today provides an update on the development of its lead programme, M6G
CAMBRIDGE, UK | December 6, 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 USA.
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 front sum along with future royalties.
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. “
SOURCE: CeNeS Pharmaceuticals plc |
