LONDON - Botanicals specialist Phytopharm plc has been granted a clinical exemption certificate to begin Phase II trials of P54, a single plant extract, in treatment of osteoarthritis.

The company said the compound has actions similar to the currently prescribed non-steroidal anti-inflammatory drugs (NSAIDS), but with none of the gastrointestinal side effects.

The NSAIDS inhibit the cyclo-oxygenase enzyme, COX2, which plays a major role in causing inflammation associated with osteoarthritis. However, they also inhibit production of another cyclo-oxygenase enzyme, COX1, causing irritation to the stomach and gastrointestinal tract.

Newer generations of these drugs have attempted to inhibit COX2 and not COX1. Phytopharm, based in Godmanchester, U.K., said P54, on which it holds patents, is able to down-regulate the production of COX2, rather than inhibit its activity. It has no effect on COX1.

Richard Dixey, Phytopharm CEO, told BioWorld International, “P54 could be regarded as a third-generation NSAID. Rather than being an enzyme inhibitor, it blocks the induction of the enzyme by TNF [tumor necrosis factor] alpha.“

P54, licensed in May 1997 from the Indonesian company Phytochemindo, is based on a traditional medicine. Dixey's claims for the compound are based on Phase II trial data from Indonesia, and on anecdotal evidence.

In the double-blind, placebo-controlled study, 200 patients will be treated for two months. Results are due by the first quarter of 1999. Dixey said the study is intended to establish efficacy and “explore the issue of gastro-protection.“ - Nuala Moran

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