Phytopharm PLC
16 November 2000
Phytopharm plc
Commences Phase II Clinical Study of P45 Cream for Alopecia Areata
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today
that it has commenced a Phase II clinical study to investigate the safety and
efficacy of its patented topical treatment, P45, for severe forms of alopecia,
including alopecia areata and totalis. Phytopharm is already undertaking a
Phase II trial investigating the safety and efficacy of P45 in alopecia
androgenica (male pattern baldness), the results of which are expected to be
available in Q1 2001.
The study will be an open label, single centre study of up to 30 subjects with
at least 50% scalp hair loss due to alopecia areata. The P45 cream will be
applied to the scalp twice daily for a period of 26 weeks. Both the
investigator and the patients will assess the extent of hair re-growth in
response to treatment. In addition, serial photographs will be taken for
evaluation at the end of the study.
Alopecia areata is a distressing condition that can affect individuals of all
ages. It is characterised by the sudden appearance of circular areas of total
hair loss, which can ultimately affect the entire scalp (termed alopecia
totalis). The underlying cause is unknown, although there is circumstantial
evidence to suggest that it is an auto-immune disorder. Although spontaneous
remission can occur in mild forms, severe forms often progress to alopecia
totalis and are unresponsive to current therapies.
Dr Richard Dixey, Chief Executive of Phytopharm, said:
'The study announced today further extends our research programme into hair
loss with our product P45. The interim review of our ongoing study in alopecia
androgenica conducted in January of this year revealed a good safety profile
for the product, and has cleared the way for the commencement of this second
study into the auto-immune form of the disease.'
Enquiries:
Phytopharm plc Tel: 01480 437697
Dr Richard Dixey, Chief Executive
Financial Dynamics Tel: 020 7831 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. Phytopharm
was recently awarded top place in the Deloitte and Touche Fast 50 award for
the fastest growing high technology companies in the Cambridge region.
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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