FDAnews
www.fdanews.com/articles/74033-corixa-announces-preliminary-results-of-crx-675-phase

CORIXA ANNOUNCES PRELIMINARY RESULTS OF CRX-675 PHASE

July 6, 2005

Corixa announced preliminary results of its first clinical trial of CRX-675, a toll-like receptor 4 (TLR4) agonist, in subjects allergic to ragweed.

The study was a randomized, blinded, placebo-controlled trial of single doses of CRX-675 given intranasally prior to intranasal challenges with ragweed allergen. The primary objective of this clinical trial was to evaluate the safety of CRX-675 given as a single intranasal dose.

Subjects were randomized to either a CRX-675 group (4 escalating dose levels n=12/group) or a placebo group (n=4/dose group; total n=16). Each subject in the study completed a series of direct nasal challenges with increasing concentrations of ragweed allergen to determine an allergen dose that would result in a 30 percent reduction in nasal volume (defined as the PD30 dose) during the screening period of the study.

There were no serious or severe adverse events reported. The majority of the adverse events were mild (Grade 1) and either considered unrelated to the drug being evaluated or resolved without intervention. The adverse event profile of CRX-675-treated subjects was similar to that of placebo-treated subjects.