LONDON ¿ The botanicals company Phytopharm plc has failed to demonstrate a difference between active and placebo groups in a Phase IIa study of its non-steroidal anti-inflammatory agent P54, in 225 patients with primary osteoarthritis.
P54 contains extracts derived from two related tropical plants that have been shown to have activity in reducing the production of the inflammatory enzyme COX2 in the joints and the gastrointestinal tract.
Patients were monitored for two months, using daily self-assessments of pain and monthly clinical assessments. Overall, 47 percent of the treatment group and 40 percent of the placebo group either improved or markedly improved during the trial, but the study failed the primary objective of demonstrating a statistical difference between active and placebo groups.
Ian Rubin, chief operating officer and medical director said, ¿There remains excellent evidence that the components of P54 have anti-inflammatory effects in man as well as in animal models of the disease. There will now be an examination of the absorption of one of the anti-inflammatory components of P54, and of the dose used in the study, in an attempt to further increase the observed effects.¿
A second study of P54 in the treatment of cancer of the colon is in progress, and Phytopharm, based in Godmanchester, Cambridgeshire, will use it to progress these investigations.
The company had brighter news on its appetite suppressant P57, being developed in collaboration with Pfizer Inc., of New York. Twenty-six of 41 preclinical studies have been completed, and a third single-dose study in humans is in progress. A repeat dose study will begin in July 1999. A Good Manufacturing Practices botanicals extraction plant, to produce product for the Phase II/III program, is now complete and two plantations have been established in South Africa to grow the raw materials.
Phytopharm also said it is making progress in establishing the mode of action of several of its compounds. It noted particularly progress with P58 for the treatment of Alzheimer¿s disease and age-related memory disorders. ¿Having completed the patent protection for the product, we are now able to reveal that the material reverses the age-related reduction in receptor numbers seen in the brains of aged animals,¿ Rubin said.
The company also released results for the six months ended Feb. 28, 1999, showing losses reduced to #1.5 million ($US2.4 million), compared to #2.3 million for the same period in 1997. n