January 18th, 2001 - 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.

INTERACTIVE

Participate in our user discussion and give your feedback and opinions! Answer our user poll which asks: Q: Do you think plant-based hair loss treatments will ever be as effective as drug treatments?

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.”

For more info about Phytopharm visit their web site http://www.phytopharm.co.uk/