Phytopharm PLC
5 February 2001
5 February 2001
Phytopharm plc
Commences Phase II Clinical Study of P54 for Inflammatory Bowel Disease
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
start of a Phase II clinical study to investigate the safety and efficacy of
its patented oral product P54, for the treatment of inflammatory bowel
disease.
The study is being conducted at Addenbrooke's Hospital, Cambridge. It has a
double-blind placebo-controlled parallel group design and will recruit up to
36 patients with steroid-dependent inflammatory bowel disease (ulcerative
colitis and Crohn's disease). Patients with clinically stable disease that are
dependent on chronic steroid therapy will be randomly assigned to receive
either P54 or placebo for up to 16 weeks. During this period their dose of
steroid will be reduced every 2 weeks until either it has been discontinued or
they become symptomatic. The primary objective of the study is to assess
whether or not treatment with P54 can reduce the dose of steroid required to
maintain disease remission in patients with steroid dependent inflammatory
bowel disease.
Inflammatory bowel disease, which includes Crohn's disease and ulcerative
colitis, is characterised by chronic inflammation of the gastrointestinal
tract, which in the case of ulcerative colitis is limited to the large bowel.
The causes of these chronic debilitating illnesses are currently unknown. The
typical symptoms include malaise, cramping abdominal pain and diarrhoea.
Affected patients usually require long term medical management, which can
often include the need for major surgery. Systemic steroids are commonly used
to treat inflammatory bowel disease, both in the short term to treat an acute
relapse and in more severe cases for sustained periods to maintain disease
remission. Steroids are powerful anti-inflammatory drugs that are associated
with highly undesirable side effects, particularly if given at high doses for
prolonged periods of time.
Dr Richard Dixey, Chief Executive of Phytopharm, said:
'It is encouraging to see P54 progressing into the clinic for this
particularly difficult to treat condition.'
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
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.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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