Phytopharm PLC
6 January 2000
Phytopharm plc announces interim review of Phase II trial for Alopecia
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announced today
that it has conducted an interim review of its Phase II clinical trial of P45,
its patented topical cream for the treatment of androgenetic alopecia (male
pattern baldness).
In this study, patients are being treated with either P45 or an inert placebo
for 52 weeks. Using a double blind trial design, 69 patients have been
randomly assigned to receive either P45 or placebo cream. Neither the
patients, the investigating physicians nor Phytopharm are aware of which
subjects are using the active material.
The purpose of the review was to examine the safety and conduct of the study
using blinded data collected from all patients after 20 weeks of treatment.
With regard to the conduct of the study, recruitment has been satisfactory and
is now complete. The safety data have revealed no treatment related serious
adverse events, and the emergent safety profile warrants the continuation of
the study. All patients are due to complete treatment during Q3 2000. An
analysis of the full data set is expected to be available in Q4 2000.
Data have been collected on the investigators' and patients' assessments of
hair growth and scalp condition. Photographic records have also been
generated. There are apparent differences between the groups according to the
various safety and efficacy parameters. However, these data collected at the
mid point of the study are preliminary and blinded with respect to the
treatment and placebo groups.
Dr. Richard Dixey, Chief Executive of Phytopharm, said:
'This study is proceeding satisfactorily but we cannot unblind the data
without invalidating the final result. We must await the full analysis of the
unblinded data at the end of the 52 week treatment period before any
conclusions can be drawn.'
Enquiries:
Phytopharm plc Tel: 01480 437697
Dr 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. These products represent a
new sector in the pharmaceutical market.
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 first time an IND has been granted for a complex botanical product,
indicating that such products may be registered as prescription medicines.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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