Research Update
Phytopharm PLC
20 January 2005
Phytopharm announces results of interim data review for phase II proof of
principle study in Alzheimer's disease
Preliminary results of completed study expected fourth quarter 2005
GODMANCHESTER, Cambridgeshire, U.K. (January 20th, 2005) - Phytopharm plc (LSE:
PYM; NASDAQBB: PHYOF; PHYOY) ('Phytopharm') announces today the outcome of a
scheduled interim data review for the ongoing phase II proof of principle
clinical study of PYM50028 (CoganeTM). The compound is an orally active,
synthetic, neuroprotective and neuroregenerative product that is under
development as a treatment for Alzheimer's disease. The study is being
conducted in the UK under the terms of a clinical trial authorisation (CTA),
which has been granted by the Medicines and Healthcare products Regulatory
Agency (MHRA).
This randomised, double-blind, placebo-controlled study is designed to evaluate
the safety, efficacy and pharmacokinetic profile of PYM50028 after once daily
oral administration for 12 weeks to patients with Alzheimer's disease. In
accordance with the protocol, an interim review was conducted after the first 60
subjects completed the study. The objectives of this review were to evaluate
the emergent safety profile of the study and to re-estimate the total number of
subjects required to measure the efficacy of PYM50028 on cognitive performance.
The safety review was conducted by an independent consultant physician, who was
provided with blinded data for each of the two treatment groups. He concluded
that 'the data obtained to date indicate that the study medication is not
associated with any safety concerns.' Therefore, the study will continue with
no changes to the safety monitoring.
The sample size re-assessment was conducted by an independent statistician, who
reported that the sample size for the study should be increased from 200 to 238
subjects. Phytopharm is seeking regulatory and ethics approval for this
amendment.
Subject recruitment for the study is expected to be completed during the second
quarter of 2005, with preliminary results still anticipated to be available in
the fourth quarter of 2005.
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: 'We are encouraged by the
emerging safety profile of CoganeTM and look forward to completing the study by
the end of the year. With more than 4.5 million people thought to be suffering
from Alzheimer's disease in the US, and similar prevalence in other major
markets, CoganeTM addresses a major opportunity where there is a clear need for
improved medication.'
-ENDS-
Company Contact: U.S. Investor Relations Contact U.K. Investor Relations Contact
Phytopharm, plc Lippert/Heilshorn & Associates, Inc Financial Dynamics
Richard Dixey Kim Sutton Golodetz (Kgolodetz@lhai.com) David Yates/Ben Atwell
+44 7867 782000 +1 212 838 3777 +44 207 831 3113
Wang Chong Bruce Voss (bvoss@lhai.com)
+44 1480 437 697 +1 310 691 7100
www.phytopharm.com
NOTES TO EDITORS
Alzheimer's disease
Alzheimer's disease is a neurodegenerative disorder that mainly affects the
elderly and is characterised by a progressive loss of learning ability and
memory. Alzheimer's disease is thought to affect 4.5 million Americans, and it
is believed that this number will continue to grow to approximately 16 million
by 2050 (Source: Alzheimer's Association). Several factors have been proposed to
play a role in the underlying neurodegeneration, including the excessive
formation of beta-amyloid, glutamate and a decrease in neurotrophic factors in
the brain.
In pre-clinical studies, the synthetic chemical PYM50028 has been shown to be
neuroprotective against beta-amyloid and glutamate damage, to reverse the
decrease of neuronal growth factors and to reverse 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 observed
in the young and causing beneficial neurite outgrowth and branching. In
addition, PYM50028 restores the learning and memory ability in Alzheimer's
disease models and thereby offers the potential to reverse the symptoms of
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).
Phytopharm plc
Phytopharm is focused on the research and development of novel pharmaceutical
and functional food products based on clinical and pre-clinical data generated
from medicinal plant extracts. The Company has seven development programmes in
four disease areas: neurodegeneration, obesity and metabolic disease,
dermatology and inflammation and has a portfolio of two marketed veterinary
products.
More information concerning Phytopharm's activities can be found on its web site
at
http://www.phytopharm.com
This press release may contain forward-looking statements within the meaning of
Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S.
Securities Exchange Act of 1934 with respect to the financial condition, results
and business achievements/performance of Phytopharm and certain of the plans and
objectives of its management. These statements are statements that are not
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', 'believes' or similar expressions, as they relate to Phytopharm, are intended
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current expectations and assumptions as to future events and circumstances that
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or results will actually occur. Any changes in such assumptions or expectations
could cause actual results to differ materially from current expectations.
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