Phytopharm PLC
03 October 2002
3rd October 2002
Phytopharm plc
Successful completion of 28 day repeat dose clinical study of
dementia treatment P58
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
successful completion of the final stage of a repeat dose clinical study for P58
which is under development as an oral treatment for age-related cognitive
dysfunction, which typically presents as memory loss and dementia, including
Alzheimer's disease.
This stage of the study utilised a randomised, double blind, placebo controlled
design to examine the safety, tolerability and pharmacokinetics of P58. Thirty
healthy men and women aged 55 years and older were enrolled and randomly
allocated to receive either P58 or placebo once daily for 28 days. Results
indicate that the product was well tolerated with a good emergent safety
profile. The pharmacokinetic data confirm biologically active concentrations of
P58 in the systemic circulation after oral dosing. A battery of 10 computerised
cognitive function tests was also performed on days 1, 14 and 28 to optimise the
cognitive endpoints for further clinical studies. These data have been
evaluated for subject variability and consistency and have led to a study design
which centres on verbal memory performance including delayed word recall and
overall quality of memory. These parameters will be the main focus of the
cognitive assessments to be conducted in the forthcoming phase II clinical
study, during which two doses of P58 will be compared with placebo over a three
month dosing period. Enrolment of subjects with memory impairment for this
study will commence during Q1, 2003.
P58 is actively neuroprotective, stimulates the release of neuronal growth
factors and reverses the loss of neuronal receptors in the ageing brain. 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: 'We have made excellent
progress in defining the mode of action of the P58 platform and can now finalise
the design of the phase II proof of principle study that will commence enrolment
of up to 150 subjects during the winter and is expected to run for a year.'
-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. 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.
Phytopharm is developing nine products based on its four drug discovery
platforms alongside a number of other projects in early evaluation phase.
The adult brain contains approximately two trillion neurones, 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.
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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