Clinical Trials

Allergy Therapeutics PLC 11 October 2006 POSITIVE OUTCOME FROM POLLINEX(R) QUATTRO RAGWEED DOSE RANGING STUDY AND SUCCESSFUL COMPLETION OF PHASE II PROGRAMME Allergy Therapeutics ("The Company") plc, the specialist pharmaceutical company focused on allergy vaccination, announces today that it has achieved a positive outcome in a dose-ranging study on Pollinex Quattro Ragweed and has now successfully completed Phase II with this therapeutic vaccine. Pollinex Quattro is an ultra-short course vaccine requiring only four shots in three weeks and incorporates the TLR4 agonist adjuvant MPL(R). Pollinex Quattro has the potential to transform allergy treatment, by providing a proven safe, effective and convenient method of vaccination. The Company has three programmes of Pollinex Quattro allergy vaccines in clinical development: Grass, Tree and Ragweed. The Company is planning on commencing Phase III studies in both Ragweed and Grass allergies in late 2006 and early 2007. With additional late stage studies also planned in the treatment of Tree allergies, Pollinex Quattro is entering the final stages of the largest ever allergy vaccine development programme and the first conducted on a global basis. The Company expects to launch the first ever approved allergy vaccine in the United States in 2009. The dose ranging study, R203, demonstrated that the therapeutic dose of Pollinex Quattro Ragweed is clearly immunogenic in a dose related manner. The therapeutic dose showed a five fold increase in immune response (IgG) after only four injections, as compared with a three fold increase in the intermediate dose group and a two fold increase in the low dose group. Since 2005, eleven studies have been conducted with Pollinex Quattro in North America involving 700 patients. Further evidence of the safety and efficacy of Pollinex Quattro is supported in clinical practice via data collected by the Company during named patient use of the vaccine in over 79,000 sufferers in Europe. Keith Carter, Chief Executive Officer of Allergy Therapeutics, said: "Today's announcement is the latest of a series of very positive development milestones in the process for achieving global registration and commercialisation of Pollinex Quattro. The global market for allergy vaccines is substantial and the potential is huge. There are over 40 million individuals with allergic rhinitis in the United States alone. The major causes of this disease are Grass, Tree and Ragweed allergens and we are pleased to be able to offer these tens of millions of patients a real chance for treatment in the near future. There is an increasing interest in allergy vaccines and their potential to cure allergic diseases. Of all companies active in allergy vaccines, Allergy Therapeutics is best placed to take a leadership role." Dr Lawrence DuBuske, President of the American Association of Certified Allergists and Consultant in Allergy at Brigham and Women's Hospital, Harvard Medical School, said "Pollinex Quattro represents a unique technological advance incorporating recent understanding of the critical role of Toll Like receptor activation in determining immune responses to potential allergens. The Pollinex Quattro combination of modified allergen which reduces allergenicity while preserving immunogenicity with simultaneous Toll like receptor activation provides both rapid efficacy and enhanced safety for allergen specific vaccination. Pollinex Quattro holds the promise of truly revolutionizing the practice 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 and tolerability of different doses of Pollinex Quattro Ragweed conducted at 4 study sites in North America under an FDA approved IND. 68 patients with a history of moderate to severe seasonal rhinoconjunctivitis, a positive skin prick test and a positive radioallergosorbent test (RAST) to ragweed allergen received 4 weekly subcutaneous injections with one of the three test doses (therapeutic, intermediate, low dose) or placebo. Immunogenicity was assessed by the serum concentration of ragweed-specific immunoglobulins (specific IgG, IgG1, IgG4, and IgE to Ragweed) compared between the three Pollinex Quattro Ragweed treatment arms and placebo. Pollinex Quattro Ragweed was able to induce immunoglobulin levels in a dose-dependent manner. Significant increases in immunoglobulin levels from baseline were most frequently detected, and of the highest magnitude, with the therapeutic dose. This increase was statistically significant with a net change in ragweed specific IgG of 445% vs. placebo (p<0.05). There were no serious adverse experiences or severe systemic reactions reported during the study. The commonest reported adverse experiences were injection site reactions (swelling, itching and pain) the majority of which were reported as mild. About Pollinex Quattro Pollinex Quattro is a four shot therapeutic vaccine for the treatment of allergic conditions which offers immediate 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 has the potential to be a novel entrant in the multibillion dollar global allergy market. Current therapeutic options in the United States and Europe are mainly limited to symptomatic therapies and conventional allergen immunotherapy which generally requires 60 to 90 shots in the United States and 30 to 60 shots in Europe over three to five years. These long dosing regimes represent a significant treatment burden for allergy sufferers. Allergy Therapeutics believes that Pollinex Quattro has the potential to become the first of several new and important disease modifying therapeutic options for patients and physicians. 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(R) and Cervarix(R). About Allergy Therapeutics plc Allergy Therapeutics plc is a London Stock Exchange (AIM) listed specialist pharmaceutical company focused on allergy vaccination. It has a profitable core business achieving sales of allergy vaccines of over £24 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. Allergy Therapeutics manufactures its own vaccine products in a MHRA approved sterile manufacturing facility in Worthing, United Kingdom. In January 2006 the Company successfully underwent an audit by the MHRA. Allergy Therapeutics has certain exclusive intellectual property rights to the use of MPL in both injected and sublingual vaccines. In addition to progressing to Phase III studies with Pollinex Quattro, the Company has commenced Phase I/II oral vaccine studies incorporating MPL. This information is provided by RNS The company news service from the London Stock Exchange
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