Phytopharm PLC
5 December 2001
5th December 2001
Phytopharm plc
Successful Completion of Proof of Principle Clinical Study of P57 for Obesity
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
successful completion of the third and final stage of its proof of principle
clinical study of P57. The objectives of this stage of the study included the
evaluation of the safety, tolerability, pharmacokinetic profile and effect on
calorie intake of P57. This is a patented product which is under development
as an appetite suppressant for the treatment of obesity and related
conditions.
This stage of the study used a double-blind, randomised, placebo-controlled
design. Nineteen overweight but otherwise healthy male volunteers were
randomly allocated to receive either P57 or placebo twice daily for 15 days.
Eighteen subjects completed the study (nine subjects in each of the P57 and
placebo groups). Assessments recorded during the study included daily calorie
intake, body weight and body fat content. The primary endpoint compared the
average daily calorie intake between the groups for the last three days of
dosing. Blood samples were also obtained for routine analysis of safety
parameters and pharmacokinetic profiling of this orally administered agent.
Preliminary data indicate that there was a statistically significant reduction
in the average daily calorie intake of the P57 group compared with the placebo
group (p= 0.014). Preliminary data also indicate a statistically significant
reduction in body fat content in the P57 group compared with the placebo group
at the completion of dosing (p=0.035). No serious adverse effects were
experienced by any of the subjects, and the safety data are consistent with a
satisfactory overall safety profile. The pharmacokinetic data confirm that
the systemic exposure to biologically active constituents of P57 was
consistent with the observed clinical effects.
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: 'This study
demonstrates proof of principle for P57. The data are very encouraging and
provide a foundation for the substantial body of work that now needs to be
done to carry the project forward to commercialisation.'
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics Tel: 0207 831 3113
David Yates / Fiona Noblet
Phytopharm also announced its preliminary results for the year ended 31 August
2001 today, a copy of which can be found on Phytopharm's website at http://
www.phytopharm.co.uk. In addition, an audio webcast of the presentation made
to analysts today will also be available on Phytopharm's website from 4pm (UK
time) today.
NOTES TO EDITORS
Phytopharm plc
Phytopharm is the leading company in the development of Botanical
pharmaceuticals. Botanicals enable the rapid clinical evaluation of plant
medicines in chronic and poorly understood diseases. Where novel modes of
action are discovered, such research can form the basis for drug discovery
platforms, which enable the development of new medicines and the isolation of
single chemical entities of clinical importance. Phytopharm has four drug
discovery platforms in full development, for obesity and metabolic syndrome,
neural and muscular degeneration, inflammation and dermatitis.
Phytopharm is developing nine products based on its four drug discovery
platforms alongside a number of other projects in early evaluation phase.
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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