Research Update

Phytopharm PLC 28 April 2004 28 April 2004 Phytopharm plc Successful completion of phase I clinical study of novel treatment for motor neurone disease Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the successful completion of a phase I clinical study to evaluate the safety, tolerability and pharmacokinetic profile of PYM50018, its patented, orally active, synthetic neuroprotective and neuroregenerative product. This is the lead compound within the P59 programme under development for the treatment of amyotrophic lateral sclerosis (ALS, the most prevalent form of motor neurone disease). This residential clinical study was conducted under an investigational new drug (IND) application filed with the US Food and Drug Administration (FDA). It utilised a randomised, double blind, placebo controlled design to evaluate the safety, tolerability and pharmacokinetic profile of single oral doses of PYM50018. The dose level was escalated across four groups of eight healthy adult male subjects (an additional two subjects in each group were randomly allocated to receive placebo). All of the subjects tolerated their allocated dose without any significant safety issues. The pharmacokinetic profile determined for each dose group confirmed that the product is bioavailable after oral administration. There was generally a linear relationship between dose, peak plasma concentration and exposure. These results will support the future conduct of a phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetic profile of PYM50018 associated with repeated daily dosing. Approximately 350,000 patients suffer from ALS worldwide, of which 50% die within 18 months of diagnosis. For the families of these patients the burden of providing supportive care is exceedingly high, and it is estimated that in the advanced stage of the disease supportive care can cost an average of $200,000 per year (source: International Alliance of ALS Associations). Treatment with the only drug currently indicated for ALS typically increases the average survival time by only three months (source Datamonitor). There is an urgent need for the development of new and more effective therapies for this devastating condition. Dr Richard Dixey, Chief Executive of Phytopharm, said: 'We continue to make strong progress in the development of this potentially important medicine.' -ENDS- Enquiries: Phytopharm plc Dr Richard Dixey, Chief Executive Tel: 01480 437697 Mobile: 07867 782000 Dr Wang Chong, Chief Financial Officer Tel: 01480 437697 Mobile: 07876 684223 Financial Dynamics David Yates / Ben Atwell Tel: 0207 831 3113 BACKGROUND INFORMATION Phytopharm plc Phytopharm is a leading company in the development of Botanical pharmaceuticals. These plant-based medicines, manufactured to pharmaceutical standards, can be clinically evaluated in chronic and poorly understood diseases. Where novel modes of action are discovered, such research can form the basis for drug discovery platforms, which enable the development of new medicines and the isolation of single chemical entities of clinical importance. Phytopharm has four drug discovery platforms for metabolic disease, neurodegeneration, inflammation and dermatology. ALS is a fatal neurodegenerative disease that most commonly strikes people between 40 and 60 years of age. The underlying cause of ALS is unknown, although approximately 5-10% of cases appear to be of familial origin. It is characterized by progressive loss of both lower (spinal cord and brainstem) and upper (cerebral cortex) motor neurones, which leads to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure. Phytopharm has developed a large group of patented compounds whose properties provide a platform for the development of novel therapeutic approaches for neurodegenerative disorders. PYM50018 has potent neuroprotective effects that have been demonstrated using various pre-clinical models. Specifically, PYM50018 has been observed to protect against neuronal damage, increase neurite outgrowth, reverse oxidative damage and reverse neuronal apoptosis in vitro. When administered orally to SOD1-G93A mice, a model of ALS, PYM50018 delays the loss of muscle strength and extends survival time. These features make PYM50018 a promising medicine for the treatment of ALS. Phytopharm is developing nine products based on its four drug discovery platforms alongside a number of other projects that are in the early phase of evaluation. 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

Companies

Ixico (IXI)
UK 100

Latest directors dealings