Phytopharm PLC
31 July 2001
31 July 2001
Phytopharm plc
Results of P54 trial in canine osteoarthritis
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
results of a randomised, double blind, placebo-controlled study of its natural
anti-inflammatory product P54 for the treatment of canine osteoarthritis (OA).
P54 is a patented non-steroidal anti-inflammatory drug (NSAID) manufactured
from 2 related plant species.
Canine OA is a chronic inflammatory disease, which mainly affects the synovial
joints, causing pain, joint swelling and stiffness with loss of function. A
variety of steroidal and non-steroidal anti-inflammatory drugs have been used
to treat dogs with OA although all are associated with adverse effects. There
is a clear need for effective and better tolerated products for the treatment
of canine OA.
A total of 61 dogs with osteoarthritis of the hip or elbow (confirmed by
radiography) were entered into the study, which was conducted by the
Department of Clinical Veterinary Science, University of Bristol Veterinary
School, UK. Fifty-four dogs were randomly allocated to receive twice daily
treatment with either P54 (n=25) or placebo (inactive) therapy (n=29) for up
to 8 weeks. The investigating veterinary surgeon and the owners were not
aware of which treatment was given to each dog.
The outcome measures included force plate analysis (peak vertical force and
vertical impulse), clinical assessment of lameness, pain on joint manipulation
and the owners' and investigator's overall assessment of response.
According to the measures of peak vertical force and vertical impulse, there
was no detectable difference in outcome between the 2 groups (p>0.05). The
changes from baseline for the clinical assessments of lameness and pain on
joint manipulation were similar in both groups.
At the end of the treatment period the investigator reported that 56% of the
dogs were 'better' or 'much better' after being treated with P54 compared to
only 26% of those treated with placebo (p=0.047). The owners' assessment of
response also favoured P54 (60%) compared with placebo (38%). The treatment
was generally well tolerated with no serious adverse events recorded. The
most common reported side effect was malodour of the animals' coat.
Commenting on the results, Dr John Innes said: 'Evaluation of treatments for
canine OA is difficult. Although we were unable to demonstrate a treatment
effect using gait analysis, there is a suggestion from the investigator's and
owners' assessments that some aspects of OA may have been improved'.
Dr Richard Dixey, Chief Executive, added: 'We are cautiously optimistic about
the results of this study and are examining options for the development and
commercialisation of the product'.
ENDS
Phytopharm plc Tel: 01480 437697
Richard Dixey, Chief Executive
Financial Dynamics Tel: 0207 831 3113
David Yates
NOTES TO EDITORS
Phytopharm plc
Phytopharm's business is to take both simple and complex mixtures derived from
plant sources into full pharmaceutical development. The US Food and Drug
Administration call such medicinal products 'Botanicals'. Botanical products
are whole or partially purified extracts of medicinal plants in which the
chemical composition is not fully characterised. Apart from being a new sector
in the pharmaceutical market, Botanicals also act as an enabling technology to
discover single chemical entities of clinical importance from plant sources.
Phytopharm is the leading company in the development of botanical
pharmaceuticals. It has developed a portfolio of 11 such products, nine of
which are in the clinical evaluation phase. These products have been targeted
in the five therapeutic categories of anti-inflammatory treatments,
neurological disorders, dermatology, cancer and metabolic diseases. In 1997,
Phytopharm was granted an Investigational New Drug (IND) approval in the US.
The guidelines for the registration of botanical products have recently been
published by the FDA.
P54 is a novel anti-inflammatory agent containing extracts derived from two
related tropical plants. Components of the product have been shown to have
activity in reducing the production of the inflammatory enzyme COX2 in the
joints and gut. This activity is consistent with its apparent efficacy in
treating Arthritis, Crohn's disease and as a cancer chemo-preventive agent.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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