Phytopharm PLC
3 December 2003
3 December 2003
Phytopharm plc
Commences phase I clinical study of treatment for motor neurone disease
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today that
it has been granted clearance by the US Food and Drug Administration to commence
a phase I clinical study, under an investigational new drug (IND) application,
to evaluate its patented oral product, PYM50018, which is the lead compound
within the P59 programme for amyotrophic lateral sclerosis (ALS, the most
prevalent form of motor neurone disease).
This residential clinical study will utilise a randomised, double blind,
placebo-controlled design. It will evaluate the safety, tolerability and
pharmacokinetic profile of single oral doses of PYM50018 that will be escalated
across four groups of eight healthy adult subjects. Each group will be assigned
a different dose level. It is expected that the results will be reported during
the second quarter of 2004.
Approximately 350,000 patients suffer from ALS world wide, of which 50% die
within 18 months of diagnosis. The financial cost to families of patients is
exceedingly high, and it is estimated that in the advanced stage, care can cost
an average of $200,000 per year (source: International Alliance of ALS
Associations). Current therapy with the only agent indicated for the treatment
of this condition increases average survival by only three months (source
Datamonitor). There is an urgent need for the development of new approaches to
this devastating condition.
Phytopharm has developed a large group of patented compounds whose properties
provide a platform for the development of novel therapeutic approaches for
neurodegenerative disorders. PYM50018 has potent neuroprotective effects that
have been demonstrated using various pre-clinical models. Specifically,
PYM50018 has been observed to protect against neuronal damage, increase neurite
outgrowth, reverse oxidative damage and reverse neuronal apoptosis in vitro.
When administered orally to SOD1-G93A mice, a model of ALS, PYM50018 delays the
loss of muscle strength and extends survival time. These features make PYM50018
a promising medicine for the treatment of ALS.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'This is the second
compound from our neurodegeneration library to enter the clinic, and it is very
gratifying to be able to advance this potentially important medicine.'
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics
David Yates / Ben Atwell Tel: 0207 831 3113
NOTES TO EDITORS
Phytopharm plc
Phytopharm is a leading company in the development of Botanical pharmaceuticals.
Botanicals enable the rapid clinical evaluation of plant medicines in chronic
and poorly understood diseases. Where novel modes of action are discovered, such
research can form the basis for drug discovery platforms, which enable the
development of new medicines and the isolation of single chemical entities of
clinical importance. Phytopharm has four drug discovery platforms in full
development, for metabolic syndrome, neurodegeneration, inflammation and
dermatitis.
ALS is a fatal neurodegenerative disease that most commonly strikes people
between 40 and 60 years of age. The underlying cause of ALS is unknown,
although approximately 5-10% of cases appear to be of familial origin. It is
characterized by progressive loss of both lower (spinal cord and brainstem) and
upper (cerebral cortex) motor neurones, which leads to severe muscle weakness
and wasting, followed by paralysis and death, generally caused by respiratory
failure.
Phytopharm is developing nine products based on its four drug discovery
platforms alongside a number of other projects that are in the early phase of
evaluation.
More information concerning Phytopharm's activities can be found on its web site
at http://www.phytopharm.co.uk.
This information is provided by RNS
The company news service from the London Stock Exchange
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