Research Update
2003年7月2日 - 4:01PM
RNSを含む英国規制内ニュース (英語)
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CeNeS announces update on the status of its clinical development
programmes focused on the treatment of pain
Cambridge, UK, 2 July 2003 - CeNeS Pharmaceuticals plc (LSE: CEN)
today announced that it has finalised its plans for the Phase III
trials of M6G (morphine-6-glucuronide) for the treatment of
post-operative pain and the early Phase II trials of CNS 5161 its
novel compound for the treatment of neuropathic pain.
M6G - for the treatment of post-operative pain
M6G has commenced an initial Phase III trial, which we anticipate
will complete in mid-2004. The trial will seek to recruit 168
patients in hospitals in three European countries. The patients will
be suffering post-operative pain following knee surgery carried out
under spinal anaesthesia. The prime objective of the study is to
compare the analgesic efficacy and duration of action of a range of
doses of M6G given intravenously, compared with placebo.
Subsequently, a second Phase III trial is then planned and it is
expected that an initial European product filing could be made in
late 2005.
Phase II clinical trials have already shown that M6G produces
equivalent analgesia to morphine to combat post-operative pain.
Additional clinical studies in post-operative nausea and vomiting
have also shown that M6G reduced the incidence of nausea and vomiting
by more than 50% when compared directly with morphine. These data
have confirmed that M6G induces equivalent analgesia to morphine
combined with an improved side effect profile. In particular M6G
appears to cause a significantly lower frequency and severity of
nausea and vomiting than morphine. If CeNeS is able to confirm in
larger phase III clinical trials that M6G causes fewer side effects
than morphine, but has equal analgesic efficacy then this could
produce an attractive alternative for patients and healthcare
providers.
CNS 5161 - for the treatment of neuropathic pain
CeNeS has finalised plans for an extended Phase II trial of CNS 5161,
a novel compound for the treatment of neuropathic pain. The Phase II
trial will commence later in 2003 and results are expected in
mid-2004. An initial phase II study has been completed in 10 patients
with chronic intractable neuropathic pain. This study demonstrated
that 0.25mg of CNS 5161 gave statistically significant pain relief.
The drug was well tolerated by the patients.
Further updates on the progress of these two trials will be given in
due course. CeNeS currently has cash reserves to complete the first
M6G Phase III trial and the planned CNS 5161 Phase II trial referred
to above. After allowing for these ongoing clinical trial expenses
CeNeS plans to have sufficient funds for ongoing operations until the
end of 2005.
Neil Clark, Chief Operating Officer and Financial Director of CeNeS
commented, "CeNeS is excited by the potential of its later stage
clinical candidates The CeNeS Board is continuing to investigate
other opportunities to enhance shareholder value".
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.
For more information please contact:
CeNeS Pharmaceuticals plc
Alan Goodman
Neil Clark
Tel: +44 (0)1223 266466
Fax: +44 (0)1223 266467
Euro RSCG Life NRP
Dr Douglas Pretsell
Tel: +44 (0)20 7726 4452
Fax: +44 (0)20 7726 4453
Notes to Editors:
CeNeS is a biopharmaceutical company specialising in the development
and commercialisation of drugs for pain control. The company has
development assets targeting pain and has a portfolio of carried
interests in assets that it has divested. The company is based in
Cambridge, England. For further information visit www.cenes.co.uk.
M6G
M6G, a natural metabolite of morphine, is in development by CeNeS for
the treatment of moderate to severe pain. Morphine is a highly
effective analgesic that has been used for many years despite the
unpleasant side effects of nausea and vomiting and the potential
dangers of respiratory depression.
M6G has undergone several Phase II clinical trials with more than 450
patients receiving M6G. The most recent Phase II trials were designed
to establish the analgesic effects of different doses of M6G
administered at different times compared to a standard morphine
treatment regime. Phase III efficacy studies are currently being
planned: a pivotal, dose-ranging placebo controlled study is
scheduled to commence as a multi-centre study in Europe in 2003 in
patients undergoing knee replacement surgery with spinal anaesthesia.
It is planned that this will be followed by a second Phase III trial
in Europe comparing M6G and morphine treatment in patients with
postoperative pain following gastrointestinal and gynaecological
surgery. Side-effect profiles of M6G will be investigated in both
studies. If these trials are successful then M6G will be on target to
be launched in Europe in 2005/6.
Opiate Analgesia
Analgesia is the process of pain-relief and any pain-relieving drug
is called an analgesic. The most potent known class of analgesics are
the opiates, derived from the opium poppy, which confer a high degree
of pain-relief for severe pain. Opiates, like morphine and codeine,
act centrally in the brain in an area called the periaqueductal grey
area where they mimic the actions of neuromodulators called
endogenous opiates and 'switch off' the sensation of pain centrally.
The markets for M6G
M6G has potential as an analgesic for two types of pain, post
- -operative pain and chronic pain, both of which are currently treated
with morphine.
For post-operative pain morphine is often used as the first line
analgesic in many of the 95 million operations performed in the USA
and Europe each year. Estimated annual sales of morphine in this
market are �400m (source: IMS and Front Line Pain Management Report,
2001). However, the undesirable side effects of morphine include
nausea, vomiting, respiratory depression and sedation. M6G is likely
to offer significant clinical benefits to morphine in the treatment
of post-operative pain due to the reduced incidence and severity of
some of these side effects, whist offering equal analgesic efficacy.
Morphine is also used frequently to treat many of the 2.7 million
patients who develop cancer each year in the USA and Europe. M6G
could compete in this �600m morphine market because M6G could
potentially lead to a reduced incidence and severity of nausea and
vomiting compared with morphine and so could improve patient well
being and quality of life.
CeNeS is initially developing M6G is for the treatment of
post-operative pain, with phase III studies planned for 2003. CeNeS
plans to also develop M6G for the treatment of chronic pain such as
cancer pain.
CNS5161
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.
The markets for CNS 5161
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. The neuropathic pain market is estimated at being worth $1.7
billion worldwide
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