COBALIS INITIATES TWO TRIALS OF RAGWEED ALLERGY DRUG

Cobalis announced that it has enrolled its first patient into its twin Phase III clinical trials of its anti-allergy medication PreHistin. The randomized, double-blind, placebo-controlled studies are intended to assess the efficacy and safety of pre-seasonal treatment with the drug in seasonal ragweed allergy patients.

The 10-week clinical trials are being conducted at 23 sites in the United States and will use electronic diary records to assess improvement in total nasal symptom score (TNSS). Approximately 1,600 to 2,000 patients will be randomized into the twin studies to receive either placebo or a 3.3-mg sublingual dose of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season, and for an additional three weeks into the season. The primary endpoint will be improvement in TNSS in weeks four, five and six. To determine the lasting effect, a secondary endpoint will measure the symptomology for patients over the last four weeks of the study.