Phytopharms press release on their clinical studies in P57

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On 5th December 2001, Phytopharm announced the successful completion of the third and final stage on their proof of principle, clinical study, of the molecule named P57. This press release states that P57, is patented by Phytopharm and is under development as an appetite suppressant for the treatment of obesity and related conditions.

The object of the clinical study was to evaluate the safety, tolerability, pharmacokinetic profile and effect on calorie intake of P57.This stage of the study used a double-blind, randomized, placebo-controlled environment. Nineteen overweight, but otherwise, healthy male volunteers who were selected randomly for the study. Nine subjects were given P57 and the remaining nine were given a placebo. Throughout the period of the study the daily calorie intake, body weight and body fat content were recorded for each participant. Blood samples were also obtained for the purpose of routine analysis on safety parameters and pharmacokinetic profiling of P57, which was administered orally.

The Press release stated that the statistical results of the tests showed a significant reduction in the average daily calorie intake of the P57 group compared with the placebo group. A reduction in body fat content in the P57 group was seen when compared with the placebo group at the completion of dosing. No serious adverse effects were felt by any of the subjects, and this result was consistent with their overall safety profile.

Dr Richard Dixey, Chief Executive of Phytopharm, said: This study demonstrates proof of principle for P57. The data are very encouraging and provide a foundation for the substantial body of work that now needs to be done to carry the project forward to commercialisation.

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