Phytopharm PLC
3 November 2003
3 November 2003
Phytopharm plc
Successful completion of phase Ib study in Alzheimer's and Parkinson's product
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
successful completion of a phase Ib clinical study of its orally active
synthetic neuroprotective and neuroregenerative product, PYM50028, which is
under development as a treatment for a range of neurological disorders,
including Alzheimer's and Parkinson's diseases (programmes P58 and P63,
respectively).
This study utilised a randomised, double blind, placebo controlled design to
examine the safety, tolerability, pharmacokinetics and cognitive effects of
PYM50028. Thirty healthy men and women aged 50 years and older were enrolled
and randomly allocated to receive either PYM50028 or placebo once daily for 28
days. Results indicate that the product has absorption and pharmacokinetic
characteristics suitable for once-daily dosing and is well tolerated with a good
emergent safety profile. A phase II clinical study in Alzheimer's patients is
now anticipated to begin shortly, during which PYM50028 will be compared with
placebo over a three-month dosing period.
The phase Ib data have now been submitted to Yamanouchi Pharmaceutical Co Ltd ('
Yamanouchi'), the results of which are the subject of the second milestone
payable under the licence agreement announced on 1 May 2003 between Yamanouchi
and Phytopharm for marketing of PYM50028 in Japan and some other Asian
countries. A total of $33 million in milestones was specified in the agreement,
subject to the achievement of specific objectives, of which $17 million will be
potentially payable to Phytopharm over the next 18 months. Phytopharm will also
receive royalties on the sale of PYM50028 by Yamanouchi.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'We are making rapid
progress in the development of PYM50028 and are encouraged with the dosing
profile of this product.'
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics
David Yates / Ben Atwell Tel: 0207 831 3113
NOTES TO EDITORS
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 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 has been shown to be
neuroprotective, to reverse the decrease of neuronal growth factors and to
reverse neuronal degeneration observed in the ageing brain. Importantly, this
product was observed to restore levels of proteins that are altered in the
ageing brain, returning them to levels seen in the young and 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 diseases. 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
The company news service from the London Stock Exchange
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