calico
05-16-2002, 07:43 AM
Maybe there's some good news in here somewhere for us.
Calico
CeNeS Announces Further Progress in its Neuropathic Pain Phase II Programme and an Update on its Other Pain Clinical Programmes
CeNeS, UK, 15 May 2002 - CeNeS Pharmaceuticals plc (LSE:CEN) today announced positive 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 programme
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 programme 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.
Calico
CeNeS Announces Further Progress in its Neuropathic Pain Phase II Programme and an Update on its Other Pain Clinical Programmes
CeNeS, UK, 15 May 2002 - CeNeS Pharmaceuticals plc (LSE:CEN) today announced positive 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 programme
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 programme 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.