Clinical update

Allergy Therapeutics PLC 21 June 2006 Allergy Therapeutics plc, "Allergy Therapeutics" or "the Company" Commencement of long term follow up study for Pollinex(R) Quattro Ragweed - R205 Quality of Life Information - R204 Allergy Therapeutics plc (AIM: AGY), the specialty pharmaceutical company focused on allergy vaccination, today announces that it has completed recruitment for its clinical trial, R205. The study is a one-year follow-up to the pivotal ragweed study, R204, that has already demonstrated Pollinex(R) Quattro's highly significant safety and efficacy benefits following one ultra-short course of treatment of 4 injections. Results from the R204 study showed a highly significant improvement in patients' symptoms after treatment with Pollinex Quattro (48% relative improvement over placebo, p=0.004). Disease modifying, allergen immunotherapy is the only treatment able to alter the course of allergic diseases; potentially preventing further sensitisations and reducing the progress from allergy to asthma. This follow-up study is designed to investigate the long term benefits of Pollinex Quattro and whether further benefit is gained by re-treating the patients one year after the initial treatment. The data obtained in this study is expected to aid in the understanding of the mechanism and duration of response of this disease modifying, potentially curative therapy. In addition, the information gained from R205 will be used to support the worldwide registration of Pollinex Quattro. The R205 study is being conducted in an environmental exposure chamber ('EEC'). Patients allergic to ragweed pollen, and previously treated with Pollinex Quattro before the 2005 pollen season, will be challenged, receive a further course of Pollinex Quattro and subsequently re-exposed to ragweed pollen in the EEC. Preliminary results from the study should be available in Q1 2007. The Pollinex Quattro allergy vaccines, which require only four injections over a three week period, have the potential to transform allergy treatment by providing a convenient, safe, effective and potentially curative method of vaccination. Pollinex Quattro Ragweed is being developed predominantly for the North American market where 26.2% of the population is sensitised to the ragweed allergen. Further global studies are being conducted in patients allergic to pollen from trees and grasses. Additional results from R204 The analysis of the results of R204 continues and the Company today announces the highlights of the quality of life ('RQLQ') measures incorporated in the study. This section of the study is designed to measure the effect of Pollinex Quattro on the patients' lifestyle and illustrates the positive effect of the vaccine on their ability to carry out day-to-day activities. Big improvements were observed in all measured domains; in particular there was a highly significant improvement in the "Practical Problems" category (43% improvement vs baseline, 137% relative improvement vs placebo; p= 0.0004). This section encompasses important, practical irritations of allergic rhinoconjunctivitis, such as blowing the nose frequently, rubbing the nose and eyes, and the constant need for tissues or handkerchiefs. Keith Carter, Chief Executive Officer, said: "From the positive pivotal outcome of our Pollinex Quattro(R) Ragweed study, R204, we know that Pollinex Quattro is highly effective in reducing symptoms of allergy to ragweed. Pollinex Quattro provided this significant benefit after only 4 injections taking only three weeks. Comparable symptom reduction would only normally be expected after 20 to 40 injections of treatment using an old-style long-course allergy vaccine. This finding is now endorsed by these excellent RQLQ results. The new study, R205, will give us an insight into the duration of these excellent patient benefits, and the value of repeated treatment in the second year. At Allergy Therapeutics, we continue to make good progress in the development of our pipeline of innovative MPL-based ultra-short-course allergy vaccines, which we believe have the potential to cure the allergies which cause misery for millions during the pollen seasons." -ends- For further information: Allergy Therapeutics plc Keith Carter, Chief Executive Officer +44 (0)1903 845 820 Bell Pottinger Dan de Belder / Emma Charlton +44 (0)20 7861 3232 About RQLQ The Rhinoconjunctivitis Quality of Life Questionnaire was developed to measure the problems that adults with rhinoconjunctivitis, both atopic and non-atopic, experience as a result of their nose and eye symptoms. It is in both self-administered and interviewer-administered formats. Patients are asked to recall their experiences during the previous week and to give their responses on a 7-point scale. The questionnaire has excellent evaluative and discriminative properties and has been used extensively throughout the world in a large number of clinical trials. R 204 study participants were asked to indicate their experiences under a number of headings in a RQLQ questionnaire modified to suit the EEC: 'non-nose/eye symptoms', 'practical problems', 'emotional' and 'global assessment' - scoring symptoms as better or worse on a graded scale. About MPL MPL(R) (Monophosphoryl Lipid A) is an immunostimulatory substance used to enhance the performance of vaccines (an 'adjuvant'). It has been widely tested, and can be characterized as a Toll-Like Receptor 4 (TLR4) agonist. Allergy Therapeutics is conducting a programme of late-phase trials of injected allergy vaccines formulated with MPL, and GSK has several vaccines in their pipeline containing MPL including Fendrix(R), a vaccine for Hepatitis A which was approved by the EMEA last year. About Allergy Therapeutics plc Allergy Therapeutics plc is an AIM-listed specialty pharmaceutical company focused on allergy vaccination. It has a profitable core business achieving sales of allergy vaccines of over £22m 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 UK, Poland, Austria, the Czech Republic and Slovakia. Allergy Therapeutics has certain exclusive intellectual property rights to the use of MPL in vaccines, both injected and oral. In addition to a phase I/II oral proof of concept study, the Company is preparing for Phase III studies of Pollinex(R) Quattro, an ultra-short course injected allergy vaccine comprising four injections administrable over as little as 3 weeks during the pollen pre-season. Discussion with the FDA and other regulatory authorities is ongoing for this late stage programme and it is hoped that the programme will be initiated on a worldwide basis during 2006. This information is provided by RNS The company news service from the London Stock Exchange
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