Parion Sciences Announces Phase I Clinical Results for Novel Dry Mouth...( Results Reported at American Asso...),Health

Results Reported at American Association for Dental Research Meeting

DURHAM, N.C., April 7, 2008 /PRNewswire/ -- Parion Sciences, Inc., a privately-held, development-stage pharmaceutical company dedicated to treating diseases resulting from the failure of the body's mucosal defenses, today announced preliminary results from a Phase I clinical safety study of a novel sodium channel blocker, P-552-02, as a topical therapy for dry mouth associated with primary Sjogren's syndrome. The preliminary results of the study showed that P-552-02 was safe and well tolerated, both locally in the oral cavity and systemically. No side effects or other safety issues were reported in the study. The results were reported on April 4 by Athena Papas, DMD, Ph.D., Professor at Tufts University School of Dental Medicine at the Annual Meeting of the American Association for Dental Research.

The trial was a 28-day, 30-patient, randomized, double-blind, placebo- controlled, crossover study designed to assess the effect of a six-time daily oral rinse formulation of P-552-02 versus placebo on oral and systemic safety parameters and the symptoms of dry mouth. The primary efficacy endpoint, a global improvement in the "feeling of dry mouth" as determined by a single retrospective "recall" report at day 28, was not met. However, an assessment of "global change in dry mouth" as determined by the change in visual analog scale (VAS) measurements 12 hours after dosing at day 7 and day 28 revealed significant improvement in the global dry mouth scores. VAS scores that measured the change at day 28 in mouth dryness, tongue dryness and ability to sleep also indicated that subjects improved on P-552-02 compared to placebo. The work was funded by Parion Sciences under a clinical study agreement with Tufts University.

"We are very encouraged with the outcome of this study. The improvements seen in this safety study, with the low dose and small sample size, demonstrate the potenti
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