Phytopharm PLC
20 May 2003
20 May 2003
Phytopharm plc
Successful completion of phase I clinical study of treatment for
Parkinson's 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 its orally active synthetic
neuroprotective and neuroregenerative product, PYM50028, which is under
development as a treatment for a series of neurological disorders, including
Parkinson's disease (programme P63).
The residential study was conducted in two stages, each utilising a
double-blind, placebo-controlled design. The first stage evaluated the safety,
tolerability and pharmacokinetics of single oral doses escalated across four
groups of eight healthy subjects. The second stage assessed the safety,
tolerability and pharmacokinetics of repeated oral dosing administered over 7
days to three groups of eight healthy subjects aged over 50 years.
These two stages have now been successfully completed. The data indicate that
PYM50028 is very well tolerated, with a good emergent safety profile and a
linear pharmacokinetic relationship between dose and systemic exposure.
The phase I study results have now enabled Phytopharm to receive approval for a
28-day randomised, double-blind, and placebo-controlled study that will enrol 30
healthy subjects aged over 50 years. This study will assess the safety,
tolerability, pharmacokinetics and cognitive effects of two dose levels of
PYM50028 administered for 28 days. The study will start immediately and results
will be reported during the third quarter of 2003.
As announced on 1 May 2003, Yamanouchi Pharmaceutical Co Ltd. has acquired an
option to license PYM50028 for a number of indications, including Parkinson's
disease, pursuant to which Phytopharm will receive licence fees, milestones and
royalties on sales in Japan and certain other Asian countries.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'the onset of neuronal
degeneration underlies both Parkinson's and Alzheimer's diseases as well as many
of the peripheral neuropathies. PYM50028 offers the potential of directly
reversing this process and significantly advancing the treatment of these
devastating conditions.'
-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 the 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 in full development, for metabolic
disease, neurodegeneration, inflammation and dermatitis.
Neurodegenerative disorders such as Parkinson's disease are chronic, progressive
conditions that predominantly affect the middle aged and elderly, causing severe
disability and premature death. In the US market alone, there are estimated to
be one million patients with diagnosed Parkinson's disease and a further two
million undiagnosed, with associated health care costs to the economy of $10
billion (source: AHP submission to US Congress).
Despite substantial progress in our understanding of these conditions over
recent years, in most cases the underlying cause(s) remain unknown. The
currently available drug therapies can provide symptomatic improvement and in
some cases may delay disease progression to a modest extent. The medical,
social and economic impact of these diseases is increasing, particularly in the
developed world, due to the ageing population.
Phytopharm is developing nine programmes based on its four drug discovery
platforms alongside a number of other projects in early evaluation.
More information concerning Phytopharm's activities can be found on its web site
at http://www.phytopharm.com
This information is provided by RNS
The company news service from the London Stock Exchange
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