CAMBRDIGE, U.K., Sept. 20, 2004 (PRIMEZONE) -- CeNeS Announces Positive Preliminary Results with M6G from Phase III Trial in Post-operative Pain
Cambridge, UK, 20 September 2004 - CeNeS Pharmaceuticals plc (LSE: CEN) ("CeNeS" or "the Company") today announced positive preliminary results in a Phase III clinical trial to assess the efficacy of M6G (morphine-6-glucuronide) as an analgesic in patients suffering from post-operative pain (p less than 0.05). The Phase III study also confirmed the effective dose of M6G and supported the findings of earlier volunteer and Phase II studies that M6G treated patients suffer less nausea and vomiting when compared to patients receiving morphine.
The study was a randomised, placebo controlled, double blind, dose ranging study of M6G versus placebo in patients (n=167) suffering post-operative pain following knee replacement surgery under spinal anaesthesia. The study's primary objective was to confirm statistically that M6G is an effective analgesic and establish the effective dose. The secondary objective was to compare safety and tolerability across groups. The study was designed to satisfy the regulatory requirements for a placebo controlled study for potential marketing authorisation application. The primary measure was morphine consumption over 12 hours post dosing.
The results, using an effective dose of M6G, show:
- Statistically significant (p less than 0.05) reduction of morphine consumption by patient controlled analgesia ("PCA")
- A single dose of M6G was effective over 12hr and through 24hr
- Equivalent pain control was observed in all study groups
- Positive trends in secondary outcome measures such as reduced nausea and vomiting were observed
CeNeS is planning to undertake a final Phase III study in Europe in patients suffering moderate and severe post-operative pain following surgical procedures (e.g. hysterectomy and gastrointestinal) carried out under general anaesthetic. The study will compare equipotent regimes of M6G initial dosing and PCA versus morphine initial dosing and PCA and will examine the analgesic efficacy and side effect profile of M6G versus morphine. Treatment groups and dosage will be finalised based upon the results of the completed Phase III study. Following the completion of the second Phase III study expected in 2005, the Directors expect an initial European product filing for the use of M6G in the treatment of acute pain following surgery could be made in 2006. The Directors expect commercial launch of M6G in Europe may be achieved in 2006/7.
Neil Clark, Chief Operating Officer and Financial Director said "M6G has been confirmed as an effective pain relieving drug for post-operative pain in this Phase III trial. Post-operative pain is experienced by the majority of patients undergoing the estimated 130 million surgical procedures that are carried out in the world each year. The global market for post-operative pain relief was valued at approximately $1 billion in 2000, and is estimated to be growing at 6-7% p.a. There is a significant opportunity for CeNeS in realising the clinical and commercial potential of M6G as an effective analgesic with a good side effect profile. In light of these positive results the Company is considering its financing options for taking this product forward, including equity funding and/ or out-licensing."
CeNeS will be making a presentation to analysts/investors at 11am today at the offices of Weil, Gotshal & Manges, One South Place, London EC2M 2WG.
This news release contains forward-looking statements that reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.
Notes to Editors: 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 www.cenes.co.uk.
About M6G M6G (morphine-6-glucuronide) is a potent active metabolite of morphine. Morphine is one of the most effective opioid analgesics and is widely used for the management of moderate to severe pain, including the pain experienced by patients following a wide range of surgical operations. Over 130 million surgical procedures are carried out in the seven major pharmaceutical markets annually.
Morphine is acknowledged to be the 'gold standard' treatment against which other parenteral analgesics are tested. Nonetheless, even after administration of morphine, various studies report that between 40-100% of patients continue to experience moderate to severe pain following surgery, indicating the clear need for new and effective treatments for post-operative pain. Morphine is also associated with a number of side effects including nausea, retching, vomiting and sedation. These side effects cause discomfort to the patient and add costs to their care by incurring the use of additional drugs to treat the side effects, as well as the costs of associated clinical and nursing care. Morphine is also associated with an increased risk of respiratory depression, a potentially fatal condition, at the higher doses required for management of severe pain.
Clinical studies have shown that M6G has an equivalent analgesic effect to morphine but also has an improved side effect profile, particularly a reduced tendency to cause nausea, vomiting, sedation and respiratory depression.
This information is provided by RNS
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