Phytopharm PLC
09 December 2003
9 December 2003
Phytopharm plc
Commences phase II proof of principle study in Alzheimer's disease
Phytopharm plc (PYM: London Stock Exchange) announces today the start of a phase
II proof of principle clinical study of its orally active, synthetic,
neuroprotective and neuroregenerative product, PYM50028, which is under
development as a treatment for Alzheimer's disease. The study will be conducted
in the UK under the terms of a clinical trial exemption (CTX) certificate, which
has been granted by the Medicines and Healthcare Products Regulatory Agency.
This study will utilise a randomised, double-blind, placebo-controlled design to
evaluate the safety, efficacy and pharmacokinetic profile of PYM50028 after once
daily oral administration to patients with Alzheimer's disease. Approximately
200 patients will be enrolled and randomly allocated to receive either PYM50028
or placebo (1:1 ratio) during a three month dosing period.
The effects of treatment with PYM50028 on memory, concentration and executive
function will be evaluated during the study. These cognitive domains, which are
particularly impaired in patients with Alzheimer's disease, will be assessed
using the Hopkin's verbal learning test and a computerised neuropsychological
test system.
Recruitment of patients for the study is expected to be completed by Q3 2004,
with a final report available Q1 2005. An interim safety analysis will be
conducted after the first 60 patients have been treated. The data will be
reviewed by an independent consultant physician, who will provide Phytopharm
with a summary report of the findings. This is expected to be available by Q3
2004.
There are no treatments currently available with the potential to reverse
Alzheimer's disease. The global annual market for Alzheimer's disease is
estimated to be worth in excess of $2.5 billion (source: Datamonitor); it is
also estimated that in the US, the total annual cost burden for Alzheimer's
disease exceeds $100 billion (source: US Alzheimer's Association).
On 1 May 2003, Phytopharm entered 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.
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'The progression of
PYM50028 into this phase II trial is an important milestone for Phytopharm. We
will progress this study vigorously over the coming year.'
-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 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
The company news service from the London Stock Exchange
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