Clinical update

Allergy Therapeutics PLC 06 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 on allergy vaccination, announces today the successful completion and positive outcome of its key Phase II dose-ranging study, G203. The positive study results support the plan to take the Company's lead product, Pollinex Quattro, into Phase 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 of Pollinex Quattro were compared to placebo in 74 patients allergic to grass and rye pollen at three centres in North America. Analyses show all 3 treatment groups had increased immunoglobulin levels over time relative to baseline levels. The immunogenicity response was most increased after treatment with the current therapeutic dose regimen of the vaccine compared to placebo. The incidence and nature of adverse experiences were as expected with a subcutaneous vaccine 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 blind controlled studies and safety experience has been gained from >60,000 named patient 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 to delivering 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 awarded the 2005 prestigious MMW-Arzneimittelpreis prize in Germany for pharmaceutical innovation." -ends- For further information: Allergy Therapeutics plc Keith Carter, Chief Executive Officer 01903 845 820 Bell Pottinger Daniel de Belder/Emma Charlton 020 7861 3232 About the G203 Study G203 was a double-blind, phase II study to evaluate the immunogenicity and tolerability of different doses of Grass M.A.T.A. MPL conducted at 3 study sites in North America under an FDA approved IND. Seventy-four patients with a history of moderate to severe seasonal rhinoconjunctivitis, a positive skin prick test and a positive radioallergosorbent test (RAST) to grass and rye allergen received 4 weekly subcutaneous injections with one of the three study test products (therapeutic regimen, intermediate dose, or low dose) or placebo. Immunogenicity was assessed by the serum concentration of grass-specific immunoglobulins (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 be dose-dependent. Significant increases in immunoglobulin levels from baseline were most frequently detected, and of the highest magnitude, with the therapeutic dose regimen containing the highest concentrations of Grass M.A.T.A. MPL, followed by the intermediate dose regimen, reaching statistical significance in the therapeutic group versus the placebo group (Timothy Grass IgG net change vs placebo 59.9%, 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 (pain (active 58%; placebo 40%), itching and swelling). However, the majority of adverse experiences were mild and overall the incidence and nature of adverse experiences was not dose related. About MPL and M.A.T.A. MPL (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 4 Receptor (TLR4) agonist. Allergy Therapeutics is conducting a programme of late phase trials in injected vaccines (Pollinex Quattro) with the adjuvant and GSK has several vaccine candidates containing MPL including Fendrix(R), a vaccine for Hepatitis B which was approved by the EMEA last year. M.A.T.A .stands for Modified Allergen Tyrosine Absorbate, other key components of the product which enhance both safety and efficacy of the vaccine and enable this ultra short treatment regimen. About Allergy Therapeutics plc Allergy Therapeutics plc is a London Stock Exchange (AIM) listed speciality pharmaceutical company focused on allergy vaccination. It has a profitable core business achieving sales of allergy vaccines of over £22 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 preparing for Phase III studies with Pollinex Quattro, the Company has commenced Phase I/ II sublingual vaccine studies incorporating MPL. This information is provided by RNS The company news service from the London Stock Exchange
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