BioWorld International Correspondent

LONDON - Phytopharm plc announced positive results in a Phase I dose-escalation study of P54 as a preventative treatment in colorectal cancer. The botanicals company said it now will seek a partner to develop P54 as a nutraceutical for patients who have been diagnosed with polyps in the colon, which confers a greatly increased risk of developing this cancer.

P54, an extract of the spice turmeric, formulated with volatile oils, is a nonsteroidal anti-inflammatory that works by inhibiting the production of the pro-inflammatory enzyme cyclo-oxygenase 2 (COX-2), which is known to be increased in inflammatory diseases and certain cancers.

"We don't believe P54 will ever be a prescription drug in cancer chemoprevention, so we intend to partner it as a medicinal food," CEO Richard Dixey told BioWorld International.

P54 is in Phase I as a treatment for Crohn's disease and ulcerative colitis, and Phytopharm, based in Godmanchester, Cambridgeshire, intends to take it forward as a prescription drug in these indications. It also has been licensed for development as a treatment for canine arthritis.

Five groups of patients (three per group) with advanced colorectal cancer were given various doses orally once a day for up to four months. Several surrogate markers of potential anticancer activity were explored, including COX-2 levels. No dose-limiting toxicity was identified, and all patients tolerated their dose.

There was a dose-dependent decrease in COX-2 levels. Three patients had stable disease over 3 months of treatment and two patients over four months. "The interesting thing about the study is that we did see therapeutic as well as chemopreventive effects. These patients were in the tertiary stages [of the disease] and lived longer than expected," Dixey said.

"We won't do another clinical trial in cancer, but with animal data, pharmacology and data from other indications, we are now in a position to look for a partner for P54 in chemoprevention."