Clinical Trials Resource Center

Sjogren's Syndrome

April 14, 2008

Parion issued mixed results from a phase I trial of P-552-02 for the treatment of dry mouth associated with primary Sjogren's syndrome. This twenty-eight day, randomized, double-blind, placebo- controlled, crossover study enrolled thirty subjects who received a six-time daily oral rinse formulation of P-552-02 or placebo. The primary efficacy endpoint, a global improvement in the "feeling of dry mouth" as determined by a single retrospective "recall" report at day twenty eight, was not met. However, an assessment of "global change in dry mouth" as determined by the change in visual analog scale (VAS) measurements twelve hours after dosing at day seven and day twenty eight revealed significant improvement in the global dry mouth scores over placebo. Based on the results Parion plans to proceed with a phase I/IIa study designed to test the efficacy of higher concentrations of P-552-02.

TaiGen released positive results from a phase II trial of nemonoxacin for the treatment of community-acquired pneumonia (CAP). This randomized, double-blind, comparative trial enrolled two hundred and sixty seven subjects. The primary endpoint was the non-inferiority of nemonoxacin in the clinical cure rate of CAP compared with levofloxacin, the current standard of care. Nemonoxacin 750 mg administered orally once daily over a period of seven days achieved non-inferiority in clinical cure rate of CAP compared with levofloxacin 500 mg once daily. Overall, 82.6% of the intent-to-treat population and 90% of the evaluable population were cured with nemonoxacin compared with 80.0% and 91% cure rate in the levofloxacin arm. Treatment was safe and well tolerated, with an adverse event profile similar between the two treatment arms. Based on the positive results, a phase II trial evaluating once-a-day intravenous dosing is scheduled to enter clinical trial the second quarter of 2008.

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