Allergy Thera. Regulatory News (AGY)

11 Oct 2006 07:00

Allergy Therapeutics PLC11 October 2006 POSITIVE OUTCOME FROM POLLINEX(R) QUATTRO RAGWEED DOSE RANGING STUDY ANDSUCCESSFUL COMPLETION OF PHASE II PROGRAMME Allergy Therapeutics ("The Company") plc, the specialist pharmaceutical companyfocused on allergy vaccination, announces today that it has achieved a positiveoutcome in a dose-ranging study on Pollinex Quattro Ragweed and has nowsuccessfully completed Phase II with this therapeutic vaccine. Pollinex Quattro is an ultra-short course vaccine requiring only four shots inthree weeks and incorporates the TLR4 agonist adjuvant MPL(R). Pollinex Quattrohas the potential to transform allergy treatment, by providing a proven safe,effective and convenient method of vaccination. The Company has three programmesof Pollinex Quattro allergy vaccines in clinical development: Grass, Tree andRagweed. The Company is planning on commencing Phase III studies in both Ragweedand Grass allergies in late 2006 and early 2007. With additional late stagestudies also planned in the treatment of Tree allergies, Pollinex Quattro isentering the final stages of the largest ever allergy vaccine developmentprogramme and the first conducted on a global basis. The Company expects tolaunch the first ever approved allergy vaccine in the United States in 2009. The dose ranging study, R203, demonstrated that the therapeutic dose of PollinexQuattro Ragweed is clearly immunogenic in a dose related manner. The therapeuticdose showed a five fold increase in immune response (IgG) after only fourinjections, as compared with a three fold increase in the intermediate dosegroup and a two fold increase in the low dose group. Since 2005, eleven studies have been conducted with Pollinex Quattro in NorthAmerica involving 700 patients. Further evidence of the safety and efficacy ofPollinex Quattro is supported in clinical practice via data collected by theCompany during named patient use of the vaccine in over 79,000 sufferers inEurope. Keith Carter, Chief Executive Officer of Allergy Therapeutics, said: "Today'sannouncement is the latest of a series of very positive development milestonesin the process for achieving global registration and commercialisation ofPollinex Quattro. The global market for allergy vaccines is substantial and thepotential is huge. There are over 40 million individuals with allergic rhinitisin the United States alone. The major causes of this disease are Grass, Tree andRagweed allergens and we are pleased to be able to offer these tens of millionsof patients a real chance for treatment in the near future. There is anincreasing interest in allergy vaccines and their potential to cure allergicdiseases. Of all companies active in allergy vaccines, Allergy Therapeutics isbest placed to take a leadership role." Dr Lawrence DuBuske, President of the American Association of CertifiedAllergists and Consultant in Allergy at Brigham and Women's Hospital, HarvardMedical School, said "Pollinex Quattro represents a unique technological advanceincorporating recent understanding of the critical role of Toll Like receptoractivation in determining immune responses to potential allergens. The PollinexQuattro combination of modified allergen which reduces allergenicity whilepreserving immunogenicity with simultaneous Toll like receptor activationprovides both rapid efficacy and enhanced safety for allergen specificvaccination. Pollinex Quattro holds the promise of truly revolutionizing thepractice of allergy treatment." -END- For further information, please contact: Allergy Therapeutics plc Keith Carter, Chief Executive Officer +44 (0)1903 845 820 Bell Pottinger Dan de Belder / Rosanne Perry +44 (0)207 861 3232 About the R203 Study R203 was a double-blind, phase II study to evaluate the immunogenicity andtolerability of different doses of Pollinex Quattro Ragweed conducted at 4 studysites in North America under an FDA approved IND. 68 patients with a history ofmoderate to severe seasonal rhinoconjunctivitis, a positive skin prick test anda positive radioallergosorbent test (RAST) to ragweed allergen received 4 weeklysubcutaneous injections with one of the three test doses (therapeutic,intermediate, low dose) or placebo. Immunogenicity was assessed by the serumconcentration of ragweed-specific immunoglobulins (specific IgG, IgG1, IgG4, andIgE to Ragweed) compared between the three Pollinex Quattro Ragweed treatmentarms and placebo. Pollinex Quattro Ragweed was able to induce immunoglobulin levels in adose-dependent manner. Significant increases in immunoglobulin levels frombaseline were most frequently detected, and of the highest magnitude, with thetherapeutic dose. This increase was statistically significant with a net changein ragweed specific IgG of 445% vs. placebo (p