Research Update

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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