Phytopharm PLC
8 November 2001
8 November 2001
Phytopharm plc
Commences repeat dose clinical study of dementia treatment, P58
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
start of a clinical study to evaluate the safety, tolerability,
pharmacokinetic profile and effect on cognitive performance of its oral
product, P58. This product is under development as a treatment for
age-related cognitive dysfunction, which typically presents as memory loss,
dementia and Alzheimer's disease.
This residential study will recruit healthy volunteers aged over 55 years in
two parts, each utilising a double blind, placebo-controlled design. The
first part will evaluate the safety, tolerability and pharmacokinetics of
repeated dosing for 7 days in three groups of eight subjects at escalating
dose. The data obtained from the first part will be used to determine the dose
for the second part of the study. The second part will determine the
tolerability, safety, pharmacokinetics and effects on cognitive performance of
repeated dosing for 28 days in up to 40 patients at a single dose level. Final
results will be reported during the second quarter of 2002.
The adult brain contains approximately two trillion nerve cells, each of which
have some 100,000 receptors on their surface. It has been estimated that from
the age of 40 people progressively lose more than 20 percent of these
receptors, resulting in a gradual decline in cognitive performance. P58 acts
by reversing this loss of nerve cell receptors in the ageing brain. This
totally novel mode of action provides a platform for the development of a
number of potentially important therapeutic approaches to diseases associated
with ageing, including memory loss and dementia. P58 is derived from one of a
family of phytochemicals found in a traditional Asian 'tonic' for the elderly
that has previously been shown to offer significant benefits to those with
dementia. Phytopharm has now developed a total of seven patent families to
protect a large family of related chemical compounds that share this activity.
A substantial programme of research is also in progress to determine the
action of this family of molecules at the level of gene expression, and
further patents concerning their mode of action are also in preparation. Based
on the emergent data, it is now anticipated that a second family of molecules,
coded P63, will commence clinical evaluation as a potential treatment for
Parkinson's disease during 2002.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'The product platform
exemplified by P58 offers tremendous potential in a range of
neuro-degenerative diseases related to ageing. The two-stage study initiated
today will enable Phytopharm to optimise the design of a three-month phase II
study for P58, planned to start in the third quarter of 2002. Furthermore, we
anticipate the emergence of further indications from the platform alongside
the programmes in Dementia and Parkinson's disease.'
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics
David Yates / Sophie Pender Cudlip Tel: 0207 831 3113
NOTES TO EDITORS
Phytopharm plc
Phytopharm is the 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, neural and
muscular degeneration, inflammation and dermatitis.
Phytopharm is developing nine products based on its four drug discovery
platforms alongside a number of other projects in early evaluation phase.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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