Clinical Trial Results

Phytopharm PLC 8 January 2001 8 January 2001 Phytopharm plc Clinical Trial Results of P54 in Colorectal Cancer Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the results of a dose escalation study of its natural anti-inflammatory product P54 in patients with advanced colorectal cancer. P54 is a patented non-steroidal anti-inflammatory drug manufactured from two related plant species. 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. P54 may therefore help prevent and treat cancer of the bowel. Bowel cancer is the second most common cancer in males in the Western world, and patients with diagnosed polyps in the colon have a greatly increased risk of developing this disease. In the UK alone, it is estimated that more than 300,000 patients have colonic polyps, and 30,000 patients die per year from advanced colorectal cancer. Following the results of several studies questioning the value of high fibre diets in reducing the incidence of colonic polyps, there is great interest in the development of novel agents that might prevent the progression of this disease. Fifteen patients with advanced colorectal cancer were entered into the study, which was conducted in collaboration with the University of Leicester, the Leicester Royal Infirmary NHS Trust and the Medical Research Council Centre for Mechanisms of Human Toxicology. Five groups of patients (3 per group) were dosed orally once a day with 2, 4, 6, 8 or 10 capsules of P54, for up to 4 months. Several surrogate markers of potential anti-cancer activity were explored, including the ex vivo induction of COX-2 by lipopolysaccharide (LPS) in whole blood. Anti-tumour activity was assessed clinically, biochemically and radiologically every 28 days. No dose limiting toxicity was identified and all of the patients tolerated their allocated dose without any significant safety issues. There was a dose-dependent decrease in COX-2 induction by LPS. Three patients exhibited stable disease radiologically during 3 months of treatment, and two patients over 4 months. The conclusion drawn was that P54 may possess cancer chemotherapeutic as well as chemopreventive efficacy. The lead investigator, Professor Will Steward from the University of Leicester School of Medicine and Biological Sciences, commented: 'We are all cautiously optimistic that inhibition of COX-2 may be an important mechanism to reduce cancer risk. The results of this trial appear to confirm that P54 is able to inhibit COX-2 and may have a role in both the prevention of colon cancer and, possibly, could form part of a treatment regimen for established disease.' Dr Richard Dixey, Chief Executive of Phytopharm, said: 'It is encouraging to see the extension of our product platform P54 into this new therapeutic area, alongside our existing studies of the product in inflammatory bowel disease and canine arthritides. It is interesting to note the possibility of this natural product having therapeutic as well as preventive efficacy in bowel cancer. We are presently considering the commercial prospects for this drug for the very large number of patients who are at risk from this disease.' -ENDS- 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. More information concerning Phytopharm's activities can be found on its Web site at http://www.phytopharm.co.uk. £ £ £

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