ALLERGY THERAPEUTICS BEGINS GRASS ALLERGY TRIAL

Allergy Therapeutics has dosed the first patient in its pivotal Phase III grass allergy trial. This international trial will take place at approximately 96 centers in four countries and will enroll more than 1,000 patients. The majority of patients will be recruited in the U.S.

Pollinex Quattro is an ultra-short-course vaccine requiring only four shots over three weeks that incorporates the TLR4 agonist adjuvant MPL. In contrast, existing vaccine treatments typically require between 16 and 50 injections taken under specialist supervision prior to the start of the hay fever season. Pollinex Quattro therefore has the potential to transform allergy treatment by providing a safe, effective and highly convenient method of vaccination, according to the company. Allergy Therapeutics has three programs of Pollinex Quattro allergy vaccines in clinical development: grass, tree and ragweed.

The primary objective of this double blind, randomized trial is to compare the efficacy of Pollinex Quattro Grass versus placebo. The trial design and endpoints have been approved by the FDA. The company plans to submit a biologics license application during the first half of 2008.

A similar Phase III trial is planned for Allergy Therapeutics' Pollinex Quattro ragweed allergy vaccine in the 2007 ragweed pollen season.