Phytopharm PLC
22 April 2002
22 April 2002
Phytopharm plc
Commencement of 28 day repeat dose clinical study of dementia treatment P58 and
completion of first stage
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
commencement of the final stage of a clinical study to evaluate the safety,
tolerability, pharmacokinetic profile and effect on cognitive performance of its
oral treatment P58. P58 is under development as a treatment for age-related
cognitive dysfunction, which typically presents as memory loss and dementia,
including Alzheimer's disease.
The first stage of the study evaluated the safety, tolerability and
pharmacokinetics of once daily dosing for up to 7 days in healthy volunteers
aged 55 years and older. This stage has now been completed and the data indicate
that P58 is well tolerated.
The second and final stage will examine the safety, tolerability,
pharmacokinetics and cognitive effects of a daily dose of P58 administered for
28 days. This stage of the study will utilise a randomised, double-blind,
placebo controlled design, and will enrol 30 healthy subjects aged 55 years and
older. Results will be reported during the third quarter of 2002, and will be
used to determine the design for a three-month, phase II study that will
commence during Q1, 2003.
The adult brain contains approximately two trillion nerve cells, each of which
have some 100,000 receptors on their surface. These receptors are replaced every
two months in healthy cells. It has been estimated that during the process of
ageing, people progressively lose more than 20 percent of these receptors,
resulting in a gradual decline in cognitive performance. Measurable reductions
in both memory and cognitive performance can be detected in healthy subjects
over the age of 55.
P58 acts by reversing this loss of nerve cell receptors in the ageing brain, as
well as actively protecting the nerve cells themselves. This novel mode of
action has established a platform for the development of a number of potentially
important therapeutic approaches to diseases associated with ageing, including
memory impairment and dementia. Phytopharm has now developed a total of nine
patent families to protect the large group of related chemical compounds within
this platform that share this activity.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'P58 has enormous promise
in both protecting brain cells from the effects of ageing and in reversing the
underlying degenerative processes. A 28 day dosing period is a short period for
the full effects of the treatment to become manifest, but the data gathered from
the cognitive testing will be instructive in finalising the design for the three
month phase II study that will commence during the winter.'
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics
David Yates 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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