Phytopharm PLC
18 January 2001
18 January 2001
Results of Phase II Trial of P45 for Male Pattern Baldness
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
results of its Phase II clinical trial of P45, a topical cream derived from a
medicinal plant for the treatment of hair loss (alopecia). This condition
includes alopecia androgenica (male pattern baldness) and alopecia areata and
totalis, both of which are the autoimmune forms of the disease.
The study in alopecia androgenica was a randomised, double blind, placebo
controlled study conducted by 3 centres within the UK. 75 patients were
randomly assigned to apply either P45 or an inert placebo cream to the bald
areas of their scalp once daily for 52 weeks. Patients were asked to attend
the clinic after the first 4 weeks of treatment and every two months
thereafter. 24 patients completed the 1 year treatment period (13 and 11 in
the P45 and placebo groups, respectively).
Data from 69 patients were analysed, carrying forward the last score generated
for those patients who dropped out of the study. The two treatment groups were
generally well matched for baseline characteristics, including the pattern,
severity and duration of alopecia. Using the primary efficacy measure of the
investigator's assessment of hair re-growth, 29% of the patients treated with
P45 were reported to have achieved hair re-growth. However, a positive
response was also reported for 38% of the placebo group which was not
statistically different compared with those that received P45. The patients
also provided their own assessment of response to treatment, which was
reported to be favourable by 21% of subjects in both treatment groups.
Possible treatment related adverse events were recorded for 34% and 24% of the
patients in the P45 and placebo groups, respectively. The majority of these
events were mild scalp reactions.
The data do not support the efficacy of P45 cream as a treatment for male
pattern baldness. However the outcome of the study may have been influenced by
the large number of patients that failed to complete the 52 week treatment
period and the unexpectedly high placebo response rate that was reported by
the investigators. The results confirm that treatment with P45 cream is
generally well tolerated and has a satisfactory overall safety profile.
Alopecia androgenica has been studied in two previously reported double blind
trials. A Phase III study on Finasteride (Merck & Co.,Inc USA) reported an
increase in mean hair density of 11% in the treatment group compared with a
loss of 2.7% in the placebo group after one year of treatment amongst 1,533
male subjects. A small study of Minoxidil (Pharmacia Corp., USA) in 36 men
treated over 96 weeks reported a 30% increase in hair mass in the treatment
group compared with an 8% loss in hair mass in the placebo group.
Dr. Richard Dixey, Chief Executive of Phytopharm, said: 'We have not met our
primary objective of demonstrating a difference between active and placebo
groups in this study, and have experienced a large placebo response which has
not previously been reported in clinical trials of this condition. The safety
data gathered from the interim analysis of this study reported early last year
has enabled us to conduct a further study in alopecia areata and totalis. We
must await the results of this latter study before deciding the future
direction of this project.'
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
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 12 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.
More information concerning Phytopharm's activities can be found on its Web
site at http://www.phytopharm.co.uk.
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