Research Update
Phytopharm PLC
28 November 2005
Company Contact: U.K. Investor Relations Contact:
Phytopharm, plc Financial Dynamics
Dr Richard Dixey David Yates / Ben Atwell
+44 7867 782000 +44 207 831 3113
www.phytopharm.com
Preliminary results of Phase II proof of principle study in Alzheimer's disease
GODMANCHESTER, Cambridgeshire, U.K. (28 November 2005) - Phytopharm plc (LSE:
PYM; NASDAQBB: PHYOF; PHYOY) ('Phytopharm') announces today the preliminary
results obtained from the Phase II proof of principle clinical study of PYM50028
(CoganeTM). The compound is novel, orally active and has neuroprotective and
neurotrophic properties. It is under development for Alzheimer's disease as a
potential disease modifying agent. The Oxford Project to Investigate Memory and
Ageing (OPTIMA) was the lead clinical centre and 15 other sites in the UK
participated in the study.
Two hundred and fifty six subjects with mild to moderate Alzheimer's disease
were randomly allocated to receive either CoganeTM (n = 127) or a placebo (n =
129) orally once daily for 12 weeks. The patients were monitored for a further 6
weeks following the completion of dosing, with measurements taken during the
study to determine the safety, efficacy and pharmacokinetic profile of CoganeTM
compared to placebo. The baseline demography data confirmed that the treatment
groups were well balanced for factors such as age, gender and severity of
disease.
The overall safety data confirm that CoganeTM administered orally once daily for
up to 12 weeks is well tolerated and has a good clinical safety profile. There
were no substantial differences in the adverse event and laboratory safety data
for each group. Treatment emergent adverse events considered to be possibly
attributable to the study medication were reported by 17 (13%) of the subjects
in the CoganeTM group and 21 (16%) of the subjects in the placebo group. Only
four subjects in the CoganeTM group prematurely discontinued the study due to an
adverse event compared with six in the placebo group.
One hundred and two subjects in the CoganeTM group and 106 subjects in the
placebo group completed the treatment period in accordance with the protocol and
were therefore included in the primary ('per- protocol') analysis. The
prospectively defined primary efficacy measure was the change in word recall
score, assessed using the Hopkins verbal learning test. The average baseline
and end of treatment scores (maximum = 36) were 12.1 (33.7%) and 12.6 (35.1%)
for the CoganeTM group, compared with 10.9 (30.2%) and 11.6 (32.2%) for the
placebo group. The baseline scores and changes over time were not significantly
different between the groups. A variety of other secondary measures of
cognitive function (including a computerised neuropsychological test battery,
the clinical dementia rating and the mini mental state examination) did not
detect significant changes over the treatment period or a difference between
CoganeTM and the placebo treatment groups in the per protocol analysis.
Commenting on these results, Professor David Smith (OPTIMA Project Leader and
Emeritus Professor of Pharmacology, Oxford University) said: 'This study
confirms that CoganeTM has a good clinical safety profile. Since the placebo
group did not show any evidence of deterioration during the 12 week treatment
period, a short term clinical study such as this is unlikely to detect a
significant treatment effect when attempting to evaluate a disease modifying
agent. However these results, together with the striking pre-clinical data,
suggest that this novel neurotrophic agent should now be taken forward into a
longer term clinical study to determine its efficacy as a treatment for
Alzheimer's disease.'
Dr Richard Dixey, Chief Executive of Phytopharm, said: 'Whilst we were surprised
by the lack of deterioration in the placebo group, the CoganeTM data show the
product has a good safety profile and was well tolerated. Taken together with
the encouraging and extensive pre-clinical and early clinical data pack we have
compiled on CoganeTM, we will immediately discuss these data with potential
licensing partners and look forward to the future development of this product.'
-ENDS-
There will be a conference call for analysts today at 4pm UK time. Please call
Claire Rowell at Financial Dynamics for details on +44 (0)207 269 7285 or email
claire.rowell@fd.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 of the US
population, 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 (CoganeTM) 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
historical facts. Words such as 'should', 'expects', 'anticipates', 'estimates
', 'believes' or similar expressions, as they relate to Phytopharm, are intended
to identify forward-looking statements. By their nature, forward-looking
statements involve risk and uncertainty because they reflect Phytopharm's
current expectations and assumptions as to future events and circumstances that
may not prove accurate. There is no guarantee that the expected events, trends
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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