Phytopharm PLC
8 January 2001
8 January 2001
Phytopharm plc
Clinical Trial Results of P54 in Colorectal Cancer
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today the
results of a dose escalation study of its natural anti-inflammatory product
P54 in patients with advanced colorectal cancer.
P54 is a patented non-steroidal anti-inflammatory drug manufactured from two
related plant species. The drug works by inhibiting the production of the
pro-inflammatory enzyme, cyclo-oxygenase 2 (COX-2), which is known to be
increased in both inflammatory diseases and certain cancers, including those
affecting the lung, breast, prostate and bowel. P54 may therefore help prevent
and treat cancer of the bowel.
Bowel cancer is the second most common cancer in males in the Western world,
and patients with diagnosed polyps in the colon have a greatly increased risk
of developing this disease. In the UK alone, it is estimated that more than
300,000 patients have colonic polyps, and 30,000 patients die per year from
advanced colorectal cancer. Following the results of several studies
questioning the value of high fibre diets in reducing the incidence of colonic
polyps, there is great interest in the development of novel agents that might
prevent the progression of this disease.
Fifteen patients with advanced colorectal cancer were entered into the study,
which was conducted in collaboration with the University of Leicester, the
Leicester Royal Infirmary NHS Trust and the Medical Research Council Centre
for Mechanisms of Human Toxicology. Five groups of patients (3 per group) were
dosed orally once a day with 2, 4, 6, 8 or 10 capsules of P54, for up to 4
months. Several surrogate markers of potential anti-cancer activity were
explored, including the ex vivo induction of COX-2 by lipopolysaccharide (LPS)
in whole blood. Anti-tumour activity was assessed clinically, biochemically
and radiologically every 28 days.
No dose limiting toxicity was identified and all of the patients tolerated
their allocated dose without any significant safety issues. There was a
dose-dependent decrease in COX-2 induction by LPS. Three patients exhibited
stable disease radiologically during 3 months of treatment, and two patients
over 4 months. The conclusion drawn was that P54 may possess cancer
chemotherapeutic as well as chemopreventive efficacy.
The lead investigator, Professor Will Steward from the University of Leicester
School of Medicine and Biological Sciences, commented: 'We are all cautiously
optimistic that inhibition of COX-2 may be an important mechanism to reduce
cancer risk. The results of this trial appear to confirm that P54 is able to
inhibit COX-2 and may have a role in both the prevention of colon cancer and,
possibly, could form part of a treatment regimen for established disease.'
Dr Richard Dixey, Chief Executive of Phytopharm, said:
'It is encouraging to see the extension of our product platform P54 into this
new therapeutic area, alongside our existing studies of the product in
inflammatory bowel disease and canine arthritides. It is interesting to note
the possibility of this natural product having therapeutic as well as
preventive efficacy in bowel cancer. We are presently considering the
commercial prospects for this drug for the very large number of patients who
are at risk from this disease.'
-ENDS-
Enquiries:
Phytopharm plc
Dr Richard Dixey, Chief Executive Tel: 01480 437697
Mobile: 07867 782000
Financial Dynamics
David Yates / Sophie Pender-Cudlip Tel: 0207 831 3113
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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