Phytopharm PLC
29 November 2000
29 November 2000
Phytopharm plc
Results of Phase I clinical trials in Alzheimer's disease and related
dementias
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
results of a Phase I single dose escalation study of P58, its novel, patented
product for the treatment of Alzheimer's disease.
The purpose of the study was to evaluate the pharmacokinetic and safety
profile of escalating single doses of P58. Twenty healthy male volunteers were
entered into the study, which was conducted at a Phase I unit in the UK. Four
subjects were allocated to each of five dose cohorts. Four cohorts of young
adults (18-45 years) were dosed orally with 80, 240, 720 and 2,400mg of P58
respectively. A final older cohort (more than 60 years old) of 4 volunteers
received a 720mg dose.
All of the volunteers tolerated their allocated dose without any significant
safety issues. The pharmacokinetic profile determined for each dose group
confirms that the product is bioavailable after oral administration to male
volunteers. The peak plasma concentration occurred between 4 and 12 hours
after dosing, followed by a terminal elimination half life of approximately 10
hours. There was generally a linear relationship between dose, peak plasma
concentration and exposure. There was no evidence of any significant
differences in the pharmacokinetic profile for the young and elderly
volunteers.
Commenting on the results, Dr Richard Dixey, Chief Executive, said:
'This is a very encouraging result which clears the way for the further
clinical development of P58 as a treatment for age related dementias,
including Alzheimer's disease. We will now commence a Phase II programme
during the summer of 2001. With the fundraising announced today, Phytopharm is
in a strong position to accelerate the development of this important new drug
family.'
ENDS
Enquiries:
Phytopharm plc Today: 0207 638 4010
Dr Richard Dixey, Chief Executive Thereafter: 01480 437697
Mobile: 0498 583754
Financial Dynamics Tel: 0207 831 3113
David Yates / 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.
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.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
£ £ £
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