Phytopharm PLC
28 April 2004
28 April 2004
Phytopharm plc
Successful completion of phase I clinical study of novel treatment for motor
neurone disease
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
successful completion of a phase I clinical study to evaluate the safety,
tolerability and pharmacokinetic profile of PYM50018, its patented, orally
active, synthetic neuroprotective and neuroregenerative product. This is the
lead compound within the P59 programme under development for the treatment of
amyotrophic lateral sclerosis (ALS, the most prevalent form of motor neurone
disease).
This residential clinical study was conducted under an investigational new drug
(IND) application filed with the US Food and Drug Administration (FDA). It
utilised a randomised, double blind, placebo controlled design to evaluate the
safety, tolerability and pharmacokinetic profile of single oral doses of
PYM50018. The dose level was escalated across four groups of eight healthy
adult male subjects (an additional two subjects in each group were randomly
allocated to receive placebo).
All of the subjects tolerated their allocated dose without any significant
safety issues. The pharmacokinetic profile determined for each dose group
confirmed that the product is bioavailable after oral administration. There was
generally a linear relationship between dose, peak plasma concentration and
exposure.
These results will support the future conduct of a phase Ib clinical study to
evaluate the safety, tolerability and pharmacokinetic profile of PYM50018
associated with repeated daily dosing.
Approximately 350,000 patients suffer from ALS worldwide, of which 50% die
within 18 months of diagnosis. For the families of these patients the burden of
providing supportive care is exceedingly high, and it is estimated that in the
advanced stage of the disease supportive care can cost an average of $200,000
per year (source: International Alliance of ALS Associations). Treatment with
the only drug currently indicated for ALS typically increases the average
survival time by only three months (source Datamonitor). There is an urgent need
for the development of new and more effective therapies for this devastating
condition.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'We continue to make
strong progress in the development of this potentially important medicine.'
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Dr Wang Chong, Chief Financial Officer Tel: 01480 437697
Mobile: 07876 684223
Financial Dynamics
David Yates / Ben Atwell Tel: 0207 831 3113
BACKGROUND INFORMATION
Phytopharm plc
Phytopharm is a leading company in the development of Botanical pharmaceuticals.
These plant-based medicines, manufactured to pharmaceutical standards, can be
clinically evaluated 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 for metabolic disease, neurodegeneration,
inflammation and dermatology.
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 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.
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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