13th Jun 2006 07:00
Evolutec Group PLC13 June 2006 For immediate release 13 June 2006 EVOLUTEC GROUP PLC ("Evolutec" or "the Company") COMMENCEMENT OF PHASE IIb ALLERGIC RHINITIS (HAY FEVER) TRIAL Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novelproducts for the treatment of allergic, inflammatory and autoimmune diseases, ispleased to announce the commencement of a 300 patient Phase IIb trial of rEV131in allergic rhinitis. This follows receipt of an unconditional 'No ObjectionLetter' from Health Canada, the Canadian regulatory authority. This multi-dose double-blind trial is being undertaken by Allied ResearchInternational ("Allied") in Toronto, Canada, under the leadership of Dr. PyushPatel. This trial aims to build on the commercial differentiation of rEV131from existing therapies and follows Evolutec's Phase IIa single dose study whichdemonstrated the rapid onset of action of rEV131 in a nasal allergen challengeformat. In particular, this study will determine the duration of action of rEV131, whichis being administered as a nasal spray. The trial will be conducted usingAllied's Environmental Exposure Chamber in which patients will be exposed tohigh levels of ragweed pollen for periods in excess of 12 hours. The primaryendpoint of the trial is the sum of symptom scores after 7 days of twice dailydosing. There are some 35 million allergic rhinitis patients in the US alone and the USallergic rhinitis market is estimated to be worth in excess of $6.6 billion.Surveys indicate that more than 70% of patients in the US are interested inadopting new treatments, one reason for which is patients' desire to move awayfrom steroid-based medications. rEV131 is a recombinant derived from a naturally occurring molecule identifiedin ticks, parasites whose saliva contains immuno-suppressive andimmuno-modulatory molecules over which Evolutec has strong patent protection. Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: "The startof this pivotal trial and the result, expected by the end of this calendar year,are important milestones in the commercialization of rEV131." ENDS For further information: Evolutec 0118 922 4480Mark Carnegie Brown, Chief Executive OfficerNicholas Badman, Chief Financial Officerwww.evolutec.co.uk Buchanan Communications 020 7466 5000Mark Court/Tim Anderson/Mary-Jane Johnson Notes for Editors: About Evolutec Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceuticalcompany with a focus on allergy, inflammation and auto-immune diseases. The Company has completed a positive 112 patient proof of concept Phase IIaclinical trial with rEV131, its lead product development candidate, in allergicrhinitis. rEV131 met the primary endpoint of reducing the sum of symptom scoresat statistically significant levels within 45mins of administration. Evolutecintends to complete proof of concept Phase II trials in post-cataract surgery in2006 and dry eye in 2006/7. Positive pre-clinical data has also been generatedin asthma. Through binding histamine, rEV131 has a unique product profile witheffects on both early and late stage inflammation. The Company has a further two product development candidates in pre-clinicaldevelopment: rEV576, a complement inhibitor, and rEV598, which is beingevaluated in CINV (chemotherapy-induced nausea and vomiting). rEV576 hasdemonstrated preclinical activity against the autoimmune disease myastheniagravis and in acute myocardial infarction ("AMI") (heart attack). Evolutec hasa research collaboration with Case Western Reserve University, Cleveland, Ohio,to carryout further preclinical testing of rEV576 in myasthenia gravis. The rights to Evolutec's vaccine technology for animals are partnered withMerial. Merial is currently undertaking work in tick-borne diseases. Evolutec is listed on the London Stock Exchange and develops therapeuticsoriginally isolated from the saliva of ticks. The tick remains undetected by itshosts, including humans, by injecting an array of molecules into the skin thatsuppresses host immunity. These stealth molecules have undergone millions ofyears of natural evolution to select a promising efficacy, potency and safetyprofile. Evolutec employs the tick's evolutionary stealth technology to offerthe potential of treating human diseases. Safe Harbour statement: this news release may contain forward-looking statementsthat reflect the current expectations of the Company regarding future events.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the successfulintegration of completed mergers and acquisitions and achievement of expectedsynergies from such transactions, and the ability of the Company to identify andconsummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Nanoco