Allergy Thera. Regulatory News (AGY)

21 Jun 2006 07:00

Allergy Therapeutics PLC21 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 companyfocused on allergy vaccination, today announces that it has completedrecruitment for its clinical trial, R205. The study is a one-year follow-up tothe pivotal ragweed study, R204, that has already demonstrated Pollinex(R)Quattro's highly significant safety and efficacy benefits following oneultra-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 overplacebo, p=0.004). Disease modifying, allergen immunotherapy is the onlytreatment able to alter the course of allergic diseases; potentially preventingfurther sensitisations and reducing the progress from allergy to asthma. Thisfollow-up study is designed to investigate the long term benefits of PollinexQuattro and whether further benefit is gained by re-treating the patients oneyear after the initial treatment. The data obtained in this study is expected toaid in the understanding of the mechanism and duration of response of thisdisease modifying, potentially curative therapy. In addition, the informationgained from R205 will be used to support the worldwide registration of PollinexQuattro. The R205 study is being conducted in an environmental exposure chamber ('EEC').Patients allergic to ragweed pollen, and previously treated with PollinexQuattro before the 2005 pollen season, will be challenged, receive a furthercourse of Pollinex Quattro and subsequently re-exposed to ragweed pollen in theEEC. Preliminary results from the study should be available in Q1 2007. The Pollinex Quattro allergy vaccines, which require only four injections over athree week period, have the potential to transform allergy treatment byproviding a convenient, safe, effective and potentially curative method ofvaccination. Pollinex Quattro Ragweed is being developed predominantly for theNorth American market where 26.2% of the population is sensitised to the ragweedallergen. Further global studies are being conducted in patients allergic topollen from trees and grasses. Additional results from R204 The analysis of the results of R204 continues and the Company today announcesthe highlights of the quality of life ('RQLQ') measures incorporated in thestudy. This section of the study is designed to measure the effect of PollinexQuattro on the patients' lifestyle and illustrates the positive effect of thevaccine on their ability to carry out day-to-day activities. Big improvements were observed in all measured domains; in particular there wasa highly significant improvement in the "Practical Problems" category (43%improvement vs baseline, 137% relative improvement vs placebo; p= 0.0004). Thissection encompasses important, practical irritations of allergicrhinoconjunctivitis, such as blowing the nose frequently, rubbing the nose andeyes, 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 ofallergy to ragweed. Pollinex Quattro provided this significant benefit afteronly 4 injections taking only three weeks. Comparable symptom reduction wouldonly normally be expected after 20 to 40 injections of treatment using anold-style long-course allergy vaccine. This finding is now endorsed by theseexcellent RQLQ results. The new study, R205, will give us an insight into theduration of these excellent patient benefits, and the value of repeatedtreatment in the second year. At Allergy Therapeutics, we continue to make good progress in the development ofour pipeline of innovative MPL-based ultra-short-course allergy vaccines, whichwe believe have the potential to cure the allergies which cause misery formillions 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 measurethe problems that adults with rhinoconjunctivitis, both atopic and non-atopic,experience as a result of their nose and eye symptoms. It is in bothself-administered and interviewer-administered formats. Patients are asked torecall their experiences during the previous week and to give their responses ona 7-point scale. The questionnaire has excellent evaluative and discriminativeproperties and has been used extensively throughout the world in a large numberof clinical trials. R 204 study participants were asked to indicate theirexperiences under a number of headings in a RQLQ questionnaire modified to suitthe EEC: 'non-nose/eye symptoms', 'practical problems', 'emotional' and 'globalassessment' - scoring symptoms as better or worse on a graded scale. About MPL MPL(R) (Monophosphoryl Lipid A) is an immunostimulatory substance used toenhance the performance of vaccines (an 'adjuvant'). It has been widely tested,and can be characterized as a Toll-Like Receptor 4 (TLR4) agonist. AllergyTherapeutics is conducting a programme of late-phase trials of injected allergyvaccines formulated with MPL, and GSK has several vaccines in their pipelinecontaining MPL including Fendrix(R), a vaccine for Hepatitis A which wasapproved by the EMEA last year. About Allergy Therapeutics plc Allergy Therapeutics plc is an AIM-listed specialty pharmaceutical companyfocused on allergy vaccination. It has a profitable core business achievingsales of allergy vaccines of over £22m in Germany, Italy, Spain and other EUmarkets through its own sales and marketing infrastructure. The company isexpanding 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 theuse of MPL in vaccines, both injected and oral. In addition to a phase I/II oralproof of concept study, the Company is preparing for Phase III studies ofPollinex(R) Quattro, an ultra-short course injected allergy vaccine comprisingfour injections administrable over as little as 3 weeks during the pollenpre-season. Discussion with the FDA and other regulatory authorities is ongoingfor this late stage programme and it is hoped that the programme will beinitiated on a worldwide basis during 2006. This information is provided by RNS The company news service from the London Stock Exchange