Results Phase I Trial in P58

Phytopharm PLC 29 November 2000 29 November 2000 Phytopharm plc Results of Phase I clinical trials in Alzheimer's disease and related dementias Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the results of a Phase I single dose escalation study of P58, its novel, patented product for the treatment of Alzheimer's disease. The purpose of the study was to evaluate the pharmacokinetic and safety profile of escalating single doses of P58. Twenty healthy male volunteers were entered into the study, which was conducted at a Phase I unit in the UK. Four subjects were allocated to each of five dose cohorts. Four cohorts of young adults (18-45 years) were dosed orally with 80, 240, 720 and 2,400mg of P58 respectively. A final older cohort (more than 60 years old) of 4 volunteers received a 720mg dose. All of the volunteers tolerated their allocated dose without any significant safety issues. The pharmacokinetic profile determined for each dose group confirms that the product is bioavailable after oral administration to male volunteers. The peak plasma concentration occurred between 4 and 12 hours after dosing, followed by a terminal elimination half life of approximately 10 hours. There was generally a linear relationship between dose, peak plasma concentration and exposure. There was no evidence of any significant differences in the pharmacokinetic profile for the young and elderly volunteers. Commenting on the results, Dr Richard Dixey, Chief Executive, said: 'This is a very encouraging result which clears the way for the further clinical development of P58 as a treatment for age related dementias, including Alzheimer's disease. We will now commence a Phase II programme during the summer of 2001. With the fundraising announced today, Phytopharm is in a strong position to accelerate the development of this important new drug family.' ENDS Enquiries: Phytopharm plc Today: 0207 638 4010 Dr Richard Dixey, Chief Executive Thereafter: 01480 437697 Mobile: 0498 583754 Financial Dynamics Tel: 0207 831 3113 David Yates / Sophie Pender-Cudlip 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. Alzheimer's disease is a significant condition of growing importance in developed countries. The prevalence of the disease is increasing and now affects more than 2% of the population aged over 55 (source: Datamonitor). The Alzheimer's Disease Association estimates that the economic costs of Alzheimer's disease exceed $100bn in the US. Pharmaceutical sales related to Alzheimer's totalled $362 million in 1998, with growth of 50% per annum, and are expected to reach $2.0-$2.5 billion by 2005 (source: Datamonitor). P58 acts by reversing the loss of nerve receptors in the ageing brain and therefore provides a totally novel mode of action with potential importance for diseases associated with ageing of the brain. The adult brain contains approximately two trillion nerve cells, each of which has some 100,000 receptors on its surface. It has been estimated however that after the age of 40, people lose about 20 percent of these receptors over the course of their lives, resulting in a gradual decline in cognitive performance. The pharmacology associated with this product may therefore offer an important advance in this therapeutic area. P58 is one of a family of phytochemicals isolated from traditional treatments for the elderly that have previously been shown to offer significant benefit in the treatment of senile dementia. More information concerning Phytopharm's activities can be found on its Web site at http://www.phytopharm.co.uk. £ £ £

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