Further Statistical Analysis of the Recent Phase III trial on Lead,Product M6G Shows Additional Benefits ( * Statistically significant reduction ...)

Further Statistical Analysis of the Recent Phase III trial on Lead,Product M6G Shows Additional Benefits

* Statistically significant reduction in sedation during the early post-operative period compared to morphine

* Statistically significant reduction in nausea in the female patient population compared to morphine

Cambridge, UK, 8th June 2007 - CeNeS Pharmaceuticals plc (AIM: CEN), the Cambridge based biopharmaceutical company, announces additional data from post-hoc analysis of the recent Phase III trial (M6G022) of M6G (morphine-6-glucuronide) in over 500 patients with post-operative pain. The Phase III data released on 20 February 2007 confirmed M6G's planned product profile and showed that M6G provided equivalent pain relief to morphine but induced significantly less post-operative nausea and vomiting (PONV).

Sedation

Analysis of the sedation data from the M6G022 trial showed statistically significant reductions in sedation in the M6G group compared to morphine in the first four hours after surgery reaching a reduction of 15% at 4 hours (p=0.007). Discussions with clinicians support the view that this is a clinically important benefit. Opiates such as morphine are well known to induce sedation and respiratory depression. Excessive sedation in the early post-operative period is associated with depression of the respiratory system, which can, in some cases, be fatal.

Nausea in female patients

It is well established that female patients undergoing surgery have a higher risk of experiencing nausea and vomiting in the post-operative period. New data analysing the female patient group (approximately 70% of the patients in the M6G022 Phase III clinical trial) showed a statistically significant reduction in nausea in the period 6-24 hours after treatment (p=0.034). The overall incidence and severity of post-operative nausea in the M6G arm for both males and females was 27% less than that observed in the morphine arm but narrowly missed statistical significance, p=0.052 (versu
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( * Statistically significant reduction ...)Further Statistical Analysis of the Recent Phase III trial on Lead,Product M6G Shows Additional Benefits,Health