Truncated study delivers positive ragweed data

The UK's Allergy Therapeutics says that a late-stage trial of its ragweed vaccine proved positive, with a statistically significant improvement in comparison to a placebo. The developer has great hopes for Pollinex Quattro--despite a clinical hold that was placed on the clinical trial by the FDA--and plans to seek approval in Canada next year.

The trial enrolled 993 patients in the U.S. and Canada. Due to a clinical hold placed on the study by the FDA related to an adverse event in an earlier study, only 381 patients received all four injections. But researchers said that the study nevertheless met its primary endpoint, demonstrating a statistically significant 12 percent benefit over placebo in the complete group.

"This trial provides us with back to back proof of the safety and efficacy of Pollinex Quattro and is truly a scientific breakthrough for allergic patients," said CEO Keith Carter. "Having successfully completed the largest ever allergy vaccine study with our grass product we are pleased to be able to announce the successful completion of the second largest ever study."

- read the Allergy Therapeutics release [1]

Related Articles:
Allergy Therapeutics afflicted by FDA's move to halt trials [2] (July 2007)
Allergy vaccine posts positive pivotal data [3] (Mar 2006)