CAMBRIDGE, U.K., May 15, 2002 (PRIMEZONE) -- CeNeS Pharmaceuticals plc (LSE:CEN) today announced postive interim results from Phase II trials of CNS 5161 for neuropathic pain.
Results from a single cohort of 10 patients with neuropathic pain have demonstrated that a 0.25mg infusion of CNS 5161, administered intravenously over 6 hours, gave statistically significant pain relief. The drug was also well tolerated by the patients. These data support the earlier Phase I study which showed CNS 5161 given intravenously at a dose of 0.5mg produced relief to a cold pain stimulus given to 16 healthy male volunteers.
This positive data supports CeNeS' plan to continue with a second Phase II multicentre, dose escalating proof-of-concept study designed to identify the lowest dose of CNS 5161 that establishes pain relief in neuropathic pain patients and the levels of the drug in blood plasma that are associated with this effect. The higher doses investigated will establish the side effect profile of CNS 5161 and the potential therapeutic window for the use of CNS 5161 in neuropathic pain. CNS 5161 in development for the treatment of neuropathic pain complements CeNeS' portfolio of products in clinical development for the treatment of moderate to severe pain.
Update on the M6G Clinical Program
In its business venture with Elan Corporation plc, CeNeS continues the development of morphine-6-glucuronide (M6G), CeNeS's lead candidate for the treatment of moderate to severe pain.
As part of a co-ordinated European and North American clinical programme, CeNeS is currently carrying out a Phase II study of M6G in patients following hip replacement surgery to investigate the effect of timing of administration of M6G in order to optimise pain control during the immediate post-operative period. Results of this study are anticipated to be available later in Q3 2002. Following the successful completion of the Phase II program M6G is expected to enter Phase III trials for the treatment of post-operative pain in 2003.
The collaboration with Elan is also developing M6G with Elan's Medipad subcutaneous drug delivery device for the treatment of chronic pain. CeNeS has commenced Phase I clinical studies in healthy volunteers to investigate the bioavailability of M6G from subcutaneous administration as preliminary studies in this programme.
Neil Clark, Chief Operating Officer and Financial Director of CeNeS, commented: "We are excited by the results from the CNS 5161 Phase II study in neuropathic pain. We are also pleased with the progress of M6G, our leading clinical candidate for the treatment of post-operative and chronic pain. Further ongoing development of these compounds gives us the opportunity to generate significant value for our shareholders."
CeNeS is a biopharmaceutical company specializing in the development and commercialization of drugs for CNS disorders and pain control. The company currently markets four products, and has research and development assets targeting pain, schizophrenia, addiction, sleep disorders and multiple sclerosis. In addition it has a range of platform technologies including AutoPatch(TM) its unique automated patch clamping technology. The group is based in Cambridge, England.
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:
Neuropathic pain is a chronic painful condition associated with injury to the nervous system and often associated with diseases such as diabetes, herpes zoster, AIDS and cancer. CNS 5161 is being developed targeting a poorly treated population of around 8 million patients suffering from neuropathic pain in the major pharmaceutical markets.
CNS 5161 is a blocker of the N-methyl-D-aspartate (NMDA) ion channel associated with the glutamate receptor. Excessive activation of the glutamate system has been implicated in the pathophysiology of neuropathic pain. These glutamate receptors are found throughout the nervous system and animal models have helped researchers uncover evidence that in the spinal chord these receptors share a special relationship with neuropathic pain. It appears that continuous activation of the NMDA ion channel in glutamate receptors reorganises pain-sensing circuits and leads to the super-sensitive quality of neuropathic pain. Agents that block these receptors, also block the pain in animals and humans.
M6G is a natural metabolite of morphine in development by CeNeS for the treatment of severe pain. Data published recently by CeNeS showed that in a phase II clinical trial directly comparing M6G with morphine in more than 140 post-operative pain patients M6G had an equivalent analgesic effect as morphine combined with a significant reduction in the frequency and severity of nausea and vomiting.
The Medipad(TM) System is a drug delivery technology that combines the convenience of a transdermal patch with the drug delivery capabilities of an infusion pump. The system is disposable, inexpensive and can be used to infuse drugs over up to a 48 hour time frame.
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