ARTICLE | Clinical News

Allergy's ragweed vaccine meets Phase III endpoint

September 23, 2008 1:41 AM UTC

Allergy (LSE:AGY) said its Pollinex Quattro Ragweed vaccine met the primary endpoint of a reduction in combined symptom/medication score in the Phase III R301 trial to treat ragweed pollen allergy. Vaccinated patients in the per protocol population had a 12% improvement vs. placebo (n=381; p=0.0478). The double-blind, U.S. and Canadian trial enrolled 993 patients.

Last year, FDA placed a clinical hold on the Pollinex Quattro program after a patient developed neurological symptoms two months after receiving injections in the Phase III G301 trial of the company's grass vaccine. Last July, the company said the ragweed vaccine was "highly unlikely" to meet its primary endpoint since the study's per protocol population was too small to show significance (See BioCentury Extra, Tuesday, July 24, 2007). ...