Allergy Therapeutics plc, the specialist pharmaceutical company focused on allergy vaccination, announces positive results from its Pollinex Quattro Grass phase III study, G301, the largest controlled allergy vaccine study ever conducted. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro has statistically significant clinical benefits over placebo.

Allergy Therapeutics intends to use the results to support a Marketing Approval Application in the European Union with a submission planned for Q1 2009. Allergy Therapeutics believes that Pollinex Quattro has the potential to transform the treatment of allergy, changing the lives of patients and providing an important new tool for the specialists who treat them. The worldwide market for allergy treatments is estimated to be in excess of $10 billion.

Study G301 examined the safety and efficacy of Pollinex Quattro in the treatment of seasonal allergic rhino-conjunctivitis (SAR) caused by grass pollen. G301 was a double-blind, placebo-controlled study comparing the symptom/medication score of patients given four injections of Pollinex Quattro to those patients receiving placebo. The trial enrolled 1,028 patients at 94 centres in the United States, Canada and Europe.

Before entry into the study, patients had suffered from SAR for an average of over 20 years and reported having moderate to severe symptoms. Patients were randomly and equally allocated to receive Pollinex Quattro or placebo. In the Intent To Treat population (all patients in the study) there was a 13.3% improvement with Pollinex Quattro over placebo (p = 0.0038), as measured by a reduction of the combined symptom/medication score (the primary efficacy endpoint). In the prospectively defined patient population who fully recorded key outcomes, Pollinex Quattro showed a dramatic improvement of 26.9% over placebo (p = 0.0031) in the same efficacy endpoint.

The data show that the safety and tolerability of Pollinex Quattro was excellent. Discontinuations due to adverse events were low (1.4% in the Pollinex Quattro arm vs. 0.8% in the placebo arm). The majority of adverse events were local reactions such as injection-site itching.

A total of 92% of patients completed the study (withdrawal rates were 8.0% in the Pollinex Quattro arm vs. 8.6% in the placebo arm). Compliance rates were higher than previously recorded in any other comparable allergy vaccine study with 95.7% of patients receiving the planned number of injections. This high level of compliance demonstrates the clear advantages of Pollinex Quattro as a four injection therapeutic vaccine, offering same season relief in as little as three weeks after treatment. Current therapeutic options are mainly limited to symptomatic therapies and/or conventional allergen immunotherapy which can require up to 90 injections in over three to five years. These long dosing regimes represent a significant treatment and economic burden for allergy sufferers.

Professor Tony Frew, Professor of Allergy and Respiratory Medicine at the Brighton and Sussex Medical School and Past President of the European Academy of Allergology and Clinical Immunology (EAACI), said: "Proof of efficacy and safety of Pollinex Quattro in this grass study is a breakthrough for allergy sufferers. Patients in this study showed significant and clinically meaningful improvement in their symptoms with a very good safety and tolerability profile. Importantly, because so few injections are required, compliance rates were excellent and this should be an area of focus for clinicians."

Keith Carter, chief executive officer of Allergy Therapeutics, said: "This is a landmark study and the most important news in the seventy year history of our Company. This study has delivered decisive proof to clinicians and patients of the value of Pollinex Quattro. It adds to an existing rich pool of data generated on Pollinex Quattro in many thousands of patients over several years and will enable us to file for regulatory approvals in Europe. This product has the potential to redefine the market for allergy products, offering sufferers a safe and effective therapy with a much more convenient treatment regime than is currently available."

Pollinex Quattro is a four injection therapeutic vaccine for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment. It is a family of specific standardised vaccines representing a potentially extensive franchise for Allergy Therapeutics and is a novel entrant in the multibillion dollar global allergy market. It is currently available in Europe on a named patient basis.

Pollinex Quattro vaccines contain three distinct technologies which act synergistically. Natural allergens are chemically modified to improve safety and allow for delivery of higher doses. These are combined with a depot technology to provide prolonged desensitization and further improved tolerability. Finally, the immune response is specifically enhanced and directed by an adjuvant, monophosphoryl lipid A (MPL). MPL is a Toll-Like 4 Receptor (TLR4) agonist and has been extensively tested in Pollinex Quattro and other late stage and registered vaccines including GlaxoSmithKline's Fendrix and Cervarix.

Evidence of the safety and efficacy of Pollinex Quattro has been established through earlier clinical trials in Europe. Furthermore, substantial exposure data in more than 100,000 patients is available from the sale of 'named patient' products in Europe.

Allergy Therapeutics plc is a London Stock Exchange (AIM) listed specialist pharmaceutical company focused on allergy vaccination. It has a growing, profitable core business achieving sales of allergy vaccines of £26 million in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. The Company is expanding its infrastructure and recently commenced operations in the United Kingdom, Poland, the Czech Republic, Slovakia and Austria.