Phytopharm PLC
10 April 2001
April 10th 2001
Phytopharm plc
Proof of Principle Clinical Study of P57 for Obesity - Successful Completion
of First Stage
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
successful completion of the first stage of its clinical study of P57 for
obesity. The objectives of the study include evaluation of the safety,
tolerability, pharmacokinetic profile and effect on calorie intake of
Phytopharm's patented oral product P57. The P57 product, licensed to Pfizer
Inc., is under development as an appetite suppressant for the treatment of
obesity.
The first stage used a double-blind, placebo-controlled design to evaluate the
safety, tolerability and pharmacokinetics of ascending single doses of P57 in
twenty-four subjects. Four groups of six healthy male volunteers were
administered either P57 (n=4) or placebo (n=2) at a dose ranging from 80 up to
2400 mg. Preliminary results indicate that all dose levels of the product were
well tolerated. Pharmacokinetic data confirm that biologically active
constituents of P57 are present in the systemic circulation after oral dosing.
The second stage of the study is currently ongoing. This is designed to assess
the safety, tolerability and pharmacokinetics of P57 when administered
repeatedly over 5 days to healthy overweight volunteers. The data obtained
from the first two stages will be used to establish the dosing regimen (dose
and duration) for the final repeat dose stage. This is designed to determine
the tolerability, safety, pharmacokinetics and effects on calorie intake of
dosing healthy, overweight volunteers for up to 15 days.
Obesity is a global problem that 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 very encouraged
with the rapid progress of this proof of principle study and look forward to
the results of the second and third stages.'
-END-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics
David Yates / Sophie Pender Cudlip 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.
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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