Phytopharm PLC
11 September 2000
Phytopharm plc
Commences Phase I clinical trials in Alzheimer's disease and related dementias
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today
that it has commenced a Phase I clinical evaluation of its patented product,
P58, for senile dementias such as Alzheimer's and Parkinson's disease.
Alzheimer's disease is a significant condition of growing importance in
developed countries. The prevalence of the disease is increasing and now
affects more than 2% of the population aged over 55 (source: Datamonitor). The
Alzheimer's Disease Association estimates that the economic costs of
Alzheimer's disease exceed $100bn in the US. Pharmaceutical sales related to
Alzheimer's totalled $362 million in 1998, with growth of 50% per annum, and
are expected to reach $2.0-$2.5 billion by 2005 (source: Datamonitor).
P58 acts by reversing the loss of nerve receptors in the ageing brain and
therefore provides a totally novel mode of action with potential importance
for diseases associated with ageing of the brain. The adult brain contains
approximately two trillion nerve cells, each of which has some 100,000
receptors on its surface. It has been estimated however that after the age of
40, people lose about 20 percent of these receptors over the course of their
lives, resulting in a gradual decline in cognitive performance. The
pharmacology associated with this product may therefore offer an important
advance in this therapeutic area. P58 is one of a family of phytochemicals
isolated from traditional treatments for the elderly that have previously been
shown to offer significant benefit in the treatment of senile dementia.
The study commencing today is a Phase I, open label, single ascending dose
study to investigate the safety, tolerability and pharmacokinetics of P58 in
healthy volunteers. The results of the study are scheduled to be reported in
Q1 2001.
Dr Richard Dixey, Chief Executive of Phytopharm, said:
'P58 has the potential to become the first in a new therapeutic class capable
of reversing the underlying loss of nerve receptors associated with the age-
related decline in cognitive function, such as Alzheimer's and Parkinson's
disease. The expanding body of data supporting the ongoing development of P58
is increasingly compelling and we are pleased by the initiation of this Phase
I clinical trial.'
Enquiries:
Phytopharm plc Tel: 01480 437697
Dr Richard Dixey, Chief Executive
Financial Dynamics Tel: 020 7831 3113
Jonathan Birt/ Sophie Pender-Cudlip
NOTES TO EDITORS
Phytopharm plc
Phytopharm's business is to take both simple and complex mixtures derived from
plant sources into full pharmaceutical development. The US Food and Drug
Administration call such medicinal products 'Botanicals'. Botanical products
are whole or partially purified extracts of medicinal plants in which the
chemical composition is not fully characterised. Apart from being a new sector
in the pharmaceutical market, Botanicals also act as an enabling technology to
discover single chemical entities of clinical importance from plant sources.
Phytopharm is the leading company in the development of botanical
pharmaceuticals. It has developed a portfolio of 11 such products, nine of
which are in the clinical evaluation phase. These products have been targeted
in the five therapeutic categories of anti-inflammatory treatments,
neurological disorders, dermatology, cancer and metabolic diseases. In 1997,
Phytopharm was granted an Investigational New Drug (IND) approval in the US.
The guidelines for the registration of botanical products have recently been
published by the FDA.
Product P58 has been studied by Phytopharm and its collaborators in an
extensive programme of pharmacological and toxicological assessment. These
studies have confirmed the novel mode of action observed with the original
plant extracts and have resulted in nine patents pending for the use of plant
extracts, their mode of action and four families of related active molecules
for the prevention of age-related decline in cognitive function, particularly
Alzheimer's and Parkinson's disease. These patents are in registration world-
wide.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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