Phytopharm PLC
5 October 2000
Phytopharm plc
Positive results of Phase II trial in canine atopic dermatitis
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
results of a randomised, double blind, placebo-controlled study of P7, its
novel, patented botanical product for the treatment of canine atopic
dermatitis (perennial canine eczema).
Forty-seven dogs with atopic dermatitis (confirmed by positive skin allergy
tests) were entered into the study, which was conducted at the Department of
Small Animal Clinical Sciences, University of Minnesota, USA. Twenty-four dogs
were randomly allocated to receive daily treatment with P7 and 23 dogs placebo
(inactive) therapy for up to 8 weeks. The veterinary surgeon and the owners
were not aware of the treatment allocation. The outcome measures included
changes in skin erythema (redness), severity of pruritis (scratching) and the
owners' overall assessment of response. These indices were analysed for
statistical significance using non-parametric two group comparisons.
The owners reported that 38% of the dogs were improved or markedly improved
after being treated with P7 compared to only 13% of those treated with the
placebo (p=0.09). There was also a notable reduction in the extent of erythema
(p=0.075) and scratching (p=0.15) in the dogs that received P7. Furthermore,
57% of the dogs in the placebo group were withdrawn from treatment due to
worsening of their condition compared with only 25% of the dogs in the P7
group, which is a highly significant result (p=0.039). The treatment was
generally well tolerated with no serious adverse events recorded.
There are approximately 100 million dogs in the US with similar numbers in
Europe and Japan. This number gives rise to a global market for health and
nutrition products used by dogs and cats of $2.21 billion (Vivash-Jones
Consultants-1999). As a condition, atopic dermatitis is more common in dogs
than cats, and estimates put the percentage of the canine population affected
by the condition at as much as 15% (Source; Animal Pharm 1998).
Commenting on the results, Professor S Torres (Head of Dermatology, Department
of Small Animal Clinical Sciences, University of Minnesota), said: 'Canine
atopic dermatitis is a common and clinically significant problem. The only
highly effective treatments currently available are associated with a lot of
unwanted side effects. This important study indicates that Phytopharm's
product P7 shows great potential for the management of this condition.'
Dr Richard Dixey, Chief Executive, added: 'This is a very encouraging result
which supports the use of P7 for the treatment of this canine disease.
Discussions are in progress with a number of potential licensees concerning
the next steps in the commercialisation of this exciting product.'
Enquiries:
Phytopharm plc Tel: 01480 437697
Richard Dixey, Chief Executive
Financial Dynamics Tel: 0207 831 3113
David Yates / Sophie Pender-Cudlip
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.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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