from the Calosol website directs you a Times article, dated 19 Sep 2000.
The Times article
"Now, after nearly 20 years of mixing lotions and potions and testing them on himself and willing volunteers in a study based in his Bognor Regis laboratory, he has developed a product called Calosol, from a common plant family that he will not publicly name.This secrecy stems partly from a confidentiality agreement with Phytopharm, the British plant-based medicines manufacturer that has been laboratory-testing Calosol for more than two years, and which claims that there have been no side effects associated with its use....Phytopharm, which calls Bouras's formula P45, has not yet decided whether it will develop it as a prescription medicine or as a special shampoo or creatn. If and when the time comes, Bouras will supply the firm with his formula.
However, in January 2001, Phytopharm announced the Phase 2 results of P45 (Calosol)). The trial was a FAILURE and it was binned. As a result, the shares in Phytopharm dived.
I remember it only too well...I WAS A SHAREHOLDER AT THE TIME !
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.'
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
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