Allergy Thera. Regulatory News (AGY)

6 Mar 2006 07:03

Allergy Therapeutics PLC06 March 2006 Allergy Therapeutics plc announces the completion of Pollinex(R) Quattro Phase II Grass programme and positive outcome of study G203 Allergy Therapeutics plc, the specialty pharmaceutical Company focused onallergy vaccination, announces today the successful completion and positiveoutcome of its key Phase II dose-ranging study, G203. The positive study resultssupport the plan to take the Company's lead product, Pollinex Quattro, intoPhase III. The G203 study is part of the Company's development of ultra short course allergy vaccines, under the brand name Pollinex Quattro, and relates specifically to the treatment of patients allergic to grass pollen. The results of this study demonstrate that Pollinex Quattro Grass - Grass M.A.T.A. (Modified Allergen Tyrosine Absorbate) with MPL(R) (Monophosphoryl Lipid A) - was safe and well tolerated at all dosing regimens and increased antibody levels compared to placebo in a dose-dependent manner. MPL is the Company's innovative TLR4-agonist which acts as an efficient allergy vaccine adjuvant. In this double-blind study, three dose regimens involving four injections ofPollinex Quattro were compared to placebo in 74 patients allergic to grass andrye pollen at three centres in North America. Analyses show all 3 treatmentgroups had increased immunoglobulin levels over time relative to baselinelevels. The immunogenicity response was most increased after treatment with thecurrent therapeutic dose regimen of the vaccine compared to placebo. Theincidence and nature of adverse experiences were as expected with a subcutaneousvaccine and were not dose-related. These results support the plans to take Pollinex Quattro into Phase III.Pollinex Quattro efficacy has also been demonstrated in previous double blindcontrolled studies and safety experience has been gained from >60,000 namedpatient exposures. Dr. Tom Holdich, head of R & D, said "This latest study, conducted in response to an FDA information requirement, adds to an already considerable body of clinical data on the Pollinex Quattro. The product has already been shown to be safe and effective in double-blind placebo-controlled studies and during extensive post-marketing surveillance which includes children and adolescents." Keith Carter, Chief Executive Officer, said:"The completion of our pre-phase III programme brings us one step closer todelivering the first and only simple, four shot allergy vaccine therapy to patients worldwide. "Pollinex Quattro has sold over 115,000 treatment sets in Europe and was awardedthe 2005 prestigious MMW-Arzneimittelpreis prize in Germany for pharmaceuticalinnovation." -ends- For further information: Allergy Therapeutics plcKeith Carter, Chief Executive Officer 01903 845 820 Bell PottingerDaniel de Belder/Emma Charlton 020 7861 3232 About the G203 Study G203 was a double-blind, phase II study to evaluate the immunogenicity andtolerability of different doses of Grass M.A.T.A. MPL conducted at 3 study sitesin North America under an FDA approved IND. Seventy-four patients with a historyof moderate to severe seasonal rhinoconjunctivitis, a positive skin prick testand a positive radioallergosorbent test (RAST) to grass and rye allergenreceived 4 weekly subcutaneous injections with one of the three study testproducts (therapeutic regimen, intermediate dose, or low dose) or placebo.Immunogenicity was assessed by the serum concentration of grass-specificimmunoglobulins (specific IgG, IgG1, IgG4, and IgE to Timothy, June and Rye)compared between the three Grass M.A.T.A. MPL treatment arms and placebo. The effect of Grass M.A.T.A. MPL on immunoglobulin levels appeared to bedose-dependent. Significant increases in immunoglobulin levels from baselinewere most frequently detected, and of the highest magnitude, with thetherapeutic dose regimen containing the highest concentrations of Grass M.A.T.A.MPL, followed by the intermediate dose regimen, reaching statisticalsignificance in the therapeutic group versus the placebo group (Timothy GrassIgG net change vs placebo 59.9%, p