Phytopharm PLC
23 August 2002
23 August 2002
Phytopharm plc
Clinical Study Results of P54 for Inflammatory Bowel Disease
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
results of a Phase IIa study to investigate the safety and efficacy of its
patented oral product P54 in inflammatory bowel disease. The study indicated
that P54, which is derived from the turmeric family, may play a role in reducing
steroid dependency in patients with less severe forms of bowel disease.
The study was conducted at Addenbrooke's Hospital, Cambridge, UK, and utilised a
double-blind placebo-controlled parallel group design. Twenty-seven patients
with steroid-dependent ulcerative colitis (n=16) or Crohn's disease (n=11) were
recruited. All recruits had clinically stable disease, but were dependent on
chronic treatment with oral prednisolone (5-30 mg/day). The patients were
randomly assigned to receive either P54 or placebo for up to 16 weeks. During
this period their dose of steroid was incrementally reduced every 2 weeks (if
clinically appropriate) until it had either been discontinued or their symptoms
of bowel disease recurred. The primary objective of the study was to assess
whether or not treatment with P54 could reduce the dose of steroid required to
maintain disease remission in patients with steroid-dependent inflammatory bowel
disease.
Faecal calprotectin (a biomarker of disease activity released by inflammatory
cells into the bowel) was determined in each subject at the start of the study.
Taking the data from all patients there was a 45% reduction in steroid dose
achieved by the P54 group with a similar result in the placebo group. However,
for patients with a baseline calprotectin level below 450 mg l-1 , all the
patients in the P54 group were able to withdraw from steroid therapy. By
contrast, in the placebo group only 44 % of patients in this category were able
to discontinue steroids without relapse.
Treatment with P54 was generally very well tolerated. There were no safety
concerns that caused any changes of dosing regimen, although a few patients
reported minor side effects such as eructation and altered taste sensation.
The lead investigator Dr John Hunter commented: 'There is a pressing need for
new, more effective treatments for inflammatory bowel disease. In this study
all the patients involved suffered from refractory, corticosteroid-dependent
disease. Although there was no overall benefit for patients taking P54, we saw
dramatic improvements in some, who managed to come off steroids completely. It
may well be that P54 will have a valuable role in less severe cases. Further
studies would be of value'.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'This small study
indicates that P54 may well be of benefit to some patients with refractory bowel
disease. We will be announcing our next steps concerning this project in the
near future'.
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
07867 782000
Financial Dynamics
Jonathan Birt / Ben Atwell 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 11 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.
P54
P54 is a patented non-steroidal anti-inflammatory drug manufactured from two
related species from the turmeric family, Curcuma Longa and Curcuma Xanthoriza.
The drug works by inhibiting the production of the pro-inflammatory enzyme,
cyclo-oxygenase 2 (COX-2), which is known to be increased in both inflammatory
diseases and certain cancers, including those affecting the lung, breast,
prostate and bowel.
Inflammatory bowel disease
Inflammatory bowel disease (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.
More information concerning Phytopharm's activities can be found on its Web site
at http://www.phytopharm.co.uk.
This information is provided by RNS
The company news service from the London Stock Exchange
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