Cobalis Reports Phase III Trial Results for PreHistin in Seasonal,Allergic Rhinitis ( tical companies studying allergy drugs ...)

Cobalis Reports Phase III Trial Results for PreHistin in Seasonal,Allergic Rhinitis

tical companies studying allergy drugs have reported problems with their clinical trials because of low symptom scores in an allergy season, with at least one report in an analogous situation occurring in the 2006 ragweed season when we conducted our trials."

The Company's chief executive officer, Gerald Yakatan, Ph.D., said, "It is unfortunate that nature did not provide the level of allergy symptoms we needed for our studies, but we continue to believe in PreHistin as a product. Cobalis remains committed to a corporate strategy based on bringing PreHistin to the consumer market. Going forward, we will continue pursuing FDA approval of PreHistin as an OTC drug if we assess the prospects for such approval to be favorable, but we will also investigate other potential marketing channels."

Details of the Study

The parallel, randomized, double-blind Phase III clinical trials for PreHistin involved 1,551 patients at 23 sites across the central, southern and eastern U.S. The patients received either a placebo or a 3.3-mg sublingual dosage of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season and for an additional three weeks into the allergy season. The primary efficacy parameter for each trial was the difference in the mean reduction in Total Nasal Symptom Score (TNSS) observed between the placebo and PreHistin over the fourth, fifth and sixth weeks of the studies. TNSS is a 12-point scale derived by summing and averaging all a.m. and p.m. scores for four symptoms: sneezing, runny nose, nasal congestion and nasal itch. Each symptom is given a score - 0 (none), 1 (mild), 2 (moderate) or 3 (severe) - resulting in a maximum recorded daily mean TNSS of 12. Patients maintained electronic diaries twice daily, self-rating their average symptoms over the previous 12 hours.

The Company delayed reporting preliminary top-line analyses from the two Phase III trials due to diary data entry inconsistencies. To evaluate wh
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( tical companies studying allergy drugs ...)Cobalis Reports Phase III Trial Results for PreHistin in Seasonal,Allergic Rhinitis,Health