Phytopharm PLC
7 March 2001
March 7th 2001
Phytopharm plc
Commences Proof of Principle Clinical Study of P57 for Obesity
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
start of a proof of principle clinical study to evaluate the safety,
tolerability, pharmacokinetic profile and effect on calorie intake of its
patented oral product P57. This product (licensed to Pfizer Inc.) is under
development as an appetite suppressant for the treatment of obesity.
This residential study is being conducted by the PPD Development Clinic,
Leicester. It will recruit up to 62 healthy male volunteers and will consist
of three stages, each utilising a double-blind, placebo-controlled design. The
first stage will evaluate the safety, tolerability and pharmacokinetics of
ascending single doses of the product. The second stage will assess the
safety, tolerability and pharmacokinetics of repeated dosing, in healthy
overweight volunteers.
The data obtained from the first two stages will be used to determine the
dosing regimen (dose and duration) for the final repeat dose stage. This will
determine the tolerability, safety, pharmacokinetics and effects on calorie
intake of dosing healthy, overweight volunteers twice daily for up to 15 days.
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' (World Health
Organisation, 1997).
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'We are pleased to be
able to report good progress with the P57 project in our collaboration with
Pfizer Inc. We await the outcome of this trial with anticipation.'
-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'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.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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