Clinical Trials Resource Center

Vasomotor Rhinitis

December 5, 2005

Rigel Pharmaceuticals issued negative results of a phase II study of R112, for the treatment of allergic rhinitis. Trial data failed to meet their primary endpoint, producing no significant reduction in symptom severity score on the total nasal symptom severity diagnostic scale, compared to placebo. Subjects receiving treatment with an approved control drug did experience such a reduction. This randomized, double-blind, controlled study enrolled 396 patients across 25 US sites, who received the drug, approved treatment with beclomethasone, or placebo twice daily for 7 days.

September 26, 2005

Evolutec has issued positive results of a phase II trial of rEV131, their recombinant immunomodulatory drug under investigation for the treatment of seasonal allergic rhinitis. Results from the study met their primary efficacy endpoint, producing a significant reduction in the mean sum of symptom scores at 15 minutes (p<0.05). Symptom relief was seen to be dose-dependent, and no serious adverse events or tolerability concerns were raised. This placebo-controlled, single-dose, dose- ranging allergen-challenge study enrolled 112 patients across 2 sites in San Antonio, Texas, who were randomized into one of four 20-patient single-dose cohorts (16 active, 4 placebo), or a fifth cohort of 32 subjects at the optimum dose (16 active, 16 placebo). Based on these results, the company announced plans to initiate a multiple-dose phase II study of the drug in the near future.

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