Phytopharm PLC
5 July 2001
July 5th 2001
Phytopharm plc
Proof of Principle Clinical Study of P57 for Obesity - Successful Completion
of Second Stage
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
successful completion of the second stage of its clinical study of P57 for
obesity. The objectives of this stage of the study include evaluation of the
safety, tolerability and pharmacokinetic profile of P57, a patented oral
product licensed to Pfizer Inc., which is under development as an appetite
suppressant for the treatment of obesity.
This second stage used a double-blind, randomised, placebo-controlled design
to evaluate the safety, tolerability and pharmacokinetics of repeated dosing
with either P57 or placebo given to eighteen subjects over 5 days. Three
groups of six overweight but otherwise healthy male volunteers were
administered either P57 or placebo daily at ascending doses.
Pharmacokinetic data confirm that there was systemic exposure to biologically
active constituents of P57. No serious adverse effects were experienced by
any of the subjects. The study will now proceed to the third stage.
The third and final stage of the study has been designed to assess the safety,
tolerability, pharmacokinetics and effects on daily calorie intake of P57
compared to placebo when administered repeatedly over at least 10 days to
healthy, overweight volunteers.
Obesity is a global problem, which affects more than 100 million people
seriously enough to warrant medical intervention. It is a direct causal
contributor to the pathophysiology of many diseases and exacerbates numerous
others. Among these are five of the leading causes of death in the
industrialised world: stroke, atherosclerosis, cardiovascular disease,
diabetes and cancer. According to the World Heath Organisation (WHO), obesity
accounts for tens of billions of pounds in direct healthcare costs worldwide.
A panel of experts convened by WHO stated on 12 June 1997 that 'obesity's
impact is so diverse and extreme that it should now be regarded as one of the
greatest neglected public health problems of our time. It has an impact on
health, which may well prove to be as great as that of smoking' QUOTE '(World
Health Organisation, 1997)' (World Health Organisation, 1997).
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'We are very encouraged
by the results of the second stage of the study and await the completion in
early November of the third and final stage of this proof of principle study'.
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics Tel: 0207 831 3113
David Yates
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 12 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.
P57 is a novel appetite suppressant containing extracts derived from a South
African plant. Under an agreement announced on August 24th 1998, Pfizer has
acquired an exclusive worldwide licence to develop and market P57. Phytopharm
will receive up to $32 million in licence fees and milestone payments based
upon the achievement of specific objectives. Phytopharm will also receive
royalties on sales of P57 by Pfizer.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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