Cambridge, U.K., June 23, 2003 (PRIMEZONE) -- Phytopharm plc (LSE:PYM) (Other OTC:PHYOF) announces today that it has entered into an agreement with the Oxford Project to Investigate Memory and Ageing (OPTIMA) regarding the clinical development of PYM50028, its novel oral treatment for dementias including Alzheimer's disease. Under the joint leadership of Professor David Smith (Project Leader, OPTIMA) and Professor Robin Jacoby (Principal Investigator), OPTIMA will enrol patients with memory impairment into the Phase II proof of principle study, which is expected to commence dosing in Q4 2003.
The study will utilise a randomised, double blind, placebo controlled design, and evaluate the safety, efficacy and pharmacokinetic profile of PYM50028 after repeated oral administration to patients with dementia. An interim safety analysis will be conducted during Q2 2004 and the study should complete by Q4 2004.
OPTIMA was founded in 1988 as part of University of Oxford's Department of Pharmacology and has since enrolled over 800 normal and cognitively impaired elderly people. Regular assessment of these volunteers has enabled the assembly of a unique and growing database of psychological, neurological, biochemical and anatomical information about the effects of ageing and cognitive impairment. The database of information enables better understanding of the key events that may trigger dementia and insights into novel approaches, such as PYM50028, to prevent and treat this devastating condition.
Today's agreement follows Phytopharm's announcement on May 1st 2003, that the Company had signed a licensing agreement with Yamanouchi Pharmaceutical Co., Ltd., a leading Japanese pharmaceutical company, for the development and commercialisation of PYM50028 in Japan and other Asian territories.
Professor David Smith, Professor of Pharmacology and Project Leader, OPTIMA, said: "PYM50028 displays an important array of pharmacological properties that are relevant to the treatment of Alzheimer's disease. Neurodegeneration plays a central role in the pathology of dementia and agents with the ability to reverse this process represent a potentially significant therapeutic advance."
Commenting on today's announcement, Richard Dixey, Chief Executive of Phytopharm, said: "OPTIMA is an excellent partner for the recruitment and evaluation of PYM50028 in patients with dementia. Their proven clinical investigative capabilities and expertise in the field provides Phytopharm with an important advantage in ensuring the rapid clinical development of this innovative therapeutic agent."
NOTES TO EDITORS
The Oxford Project to Investigate Memory and Ageing (OPTIMA) OPTIMA is one of the UK's leading centres for the study of dementia and has pioneered the use of neuroimaging as a diagnostic aid and for following the progression of Alzheimer's disease. Its cohort of more than 800 subjects is unique in the world for the detailed longitudinal data covering clinical assessment, neuropsychology, neuroimaging, biochemistry and genetics.
More information concerning OPTIMA can be found on its web site at http://www.pharm.ox.ac.uk/optima.htm
Phytopharm plc
Phytopharm is the 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 in full development, for metabolic disease, neurodegeneration, inflammation and dermatology.
PYM50028 arose from research into the activity of an Asian medicinal plant. In pre-clinical studies, this synthetic chemical is neuroprotective, reverses the decrease of neuronal growth factors and reverses neuronal degeneration observed in the ageing brain. Importantly, this product restores levels of proteins that are altered in the ageing brain, returning them to levels seen in the young, causing beneficial neurite outgrowth and branching. PYM50028 thereby offers the potential of disease modification in poorly treated but prevalent neurodegenerative conditions such as Alzheimer's and Parkinson's disease. The neurodegeneration platform, from which PYM50028 has been developed, is protected by nine global patent families and contains a library of related chemical compounds that share this mode of action.
Phytopharm is developing nine programmes based on its four drug discovery platforms alongside a number of other projects in early evaluation.
More information concerning Phytopharm's activities can be found on its web site at http://www.phytopharm.com
This information is provided by RNS
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