Research Update

Phytopharm PLC 31 July 2001 31 July 2001 Phytopharm plc Results of P54 trial in canine osteoarthritis Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the results of a randomised, double blind, placebo-controlled study of its natural anti-inflammatory product P54 for the treatment of canine osteoarthritis (OA). P54 is a patented non-steroidal anti-inflammatory drug (NSAID) manufactured from 2 related plant species. Canine OA is a chronic inflammatory disease, which mainly affects the synovial joints, causing pain, joint swelling and stiffness with loss of function. A variety of steroidal and non-steroidal anti-inflammatory drugs have been used to treat dogs with OA although all are associated with adverse effects. There is a clear need for effective and better tolerated products for the treatment of canine OA. A total of 61 dogs with osteoarthritis of the hip or elbow (confirmed by radiography) were entered into the study, which was conducted by the Department of Clinical Veterinary Science, University of Bristol Veterinary School, UK. Fifty-four dogs were randomly allocated to receive twice daily treatment with either P54 (n=25) or placebo (inactive) therapy (n=29) for up to 8 weeks. The investigating veterinary surgeon and the owners were not aware of which treatment was given to each dog. The outcome measures included force plate analysis (peak vertical force and vertical impulse), clinical assessment of lameness, pain on joint manipulation and the owners' and investigator's overall assessment of response. According to the measures of peak vertical force and vertical impulse, there was no detectable difference in outcome between the 2 groups (p>0.05). The changes from baseline for the clinical assessments of lameness and pain on joint manipulation were similar in both groups. At the end of the treatment period the investigator reported that 56% of the dogs were 'better' or 'much better' after being treated with P54 compared to only 26% of those treated with placebo (p=0.047). The owners' assessment of response also favoured P54 (60%) compared with placebo (38%). The treatment was generally well tolerated with no serious adverse events recorded. The most common reported side effect was malodour of the animals' coat. Commenting on the results, Dr John Innes said: 'Evaluation of treatments for canine OA is difficult. Although we were unable to demonstrate a treatment effect using gait analysis, there is a suggestion from the investigator's and owners' assessments that some aspects of OA may have been improved'. Dr Richard Dixey, Chief Executive, added: 'We are cautiously optimistic about the results of this study and are examining options for the development and commercialisation of the product'. ENDS Phytopharm plc Tel: 01480 437697 Richard Dixey, Chief Executive Financial Dynamics Tel: 0207 831 3113 David Yates 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. In 1997, Phytopharm was granted an Investigational New Drug (IND) approval in the US. The guidelines for the registration of botanical products have recently been published by the FDA. P54 is a novel anti-inflammatory agent containing extracts derived from two related tropical plants. Components of the product have been shown to have activity in reducing the production of the inflammatory enzyme COX2 in the joints and gut. This activity is consistent with its apparent efficacy in treating Arthritis, Crohn's disease and as a cancer chemo-preventive agent. More information concerning Phytopharm's activities can be found on its Web site at http://www.phytopharm.co.uk.

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