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Ph IIb Hay Fever Trial Starts
Ph IIb Hay Fever Trial Starts.
About this update from Nanoco Group Plc
[{"type":"text","content":"\n Evolutec Group PLC\n13 June 2006\n\n\nFor immediate release 13 June 2006\n\n EVOLUTEC GROUP PLC\n ('Evolutec' or 'the Company')\n\n\n COMMENCEMENT OF PHASE IIb ALLERGIC RHINITIS (HAY FEVER) TRIAL\n\n\nEvolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel\nproducts for the treatment of allergic, inflammatory and autoimmune diseases, is\npleased to announce the commencement of a 300 patient Phase IIb trial of rEV131\nin allergic rhinitis. This follows receipt of an unconditional 'No Objection\nLetter' from Health Canada, the Canadian regulatory authority.\n\n\nThis multi-dose double-blind trial is being undertaken by Allied Research\nInternational ('Allied') in Toronto, Canada, under the leadership of Dr. Pyush\nPatel. This trial aims to build on the commercial differentiation of rEV131\nfrom existing therapies and follows Evolutec's Phase IIa single dose study which\ndemonstrated the rapid onset of action of rEV131 in a nasal allergen challenge\nformat.\n\n\nIn particular, this study will determine the duration of action of rEV131, which\nis being administered as a nasal spray. The trial will be conducted using\nAllied's Environmental Exposure Chamber in which patients will be exposed to\nhigh levels of ragweed pollen for periods in excess of 12 hours. The primary\nendpoint of the trial is the sum of symptom scores after 7 days of twice daily\ndosing.\n\n\nThere are some 35 million allergic rhinitis patients in the US alone and the US\nallergic rhinitis market is estimated to be worth in excess of $6.6 billion.\nSurveys indicate that more than 70% of patients in the US are interested in\nadopting new treatments, one reason for which is patients' desire to move away\nfrom steroid-based medications.\n\n\nrEV131 is a recombinant derived from a naturally occurring molecule identified\nin ticks, parasites whose saliva contains immuno-suppressive and\nimmuno-modulatory molecules over which Evolutec has strong patent protection.\n\n\nMark Carnegie Brown, Evolutec's Chief Executive Officer, commented: 'The start\nof this pivotal trial and the result, expected by the end of this calendar year,\nare important milestones in the commercialization of rEV131.'\n\n\n ENDS\n\n\nFor further information:\n\nEvolutec 0118 922 4480\nMark Carnegie Brown, Chief Executive Officer\nNicholas Badman, Chief Financial Officer\nwww...