Rhinitis IND

Evolutec Group PLC 18 April 2005 For immediate release 18 April 2005 EVOLUTEC GROUP PLC ('Evolutec' or 'the Company') FDA approval to commence proof of concept trial in allergic rhinitis in the US Evolutec Group plc (AIM: EVC), a biopharmaceutical company developing novel products for the treatment of allergic, inflammatory and autoimmune diseases, is pleased to announce that it has obtained an Investigational New Drug ('IND') approval (BB-IND12264) from the US Food and Drug Administration ('FDA'). This IND allows Evolutec to commence a proof of concept clinical study in the US of its lead compound rEV131 in allergic rhinitis (hay fever). This randomised double-blind Phase II trial will seek to demonstrate an improvement versus placebo in the four nasal symptoms of rhinitis: mucus production, congestion, sneeze and itch. rEV131 will be administered nasally and the trial will involve the treatment of 112 patients. There will be four cohorts of 16 patients each on ascending doses of rEV131 versus placebo, followed by an extra cohort of 16 patients versus placebo at the most efficacious dose. The trial will take place at two centres in San Antonio, Texas, under the leadership of Dr Paul Ratner, a leading clinician in the respiratory field. The clinical phase is expected to take five months with analysis of the data complete by the end of 2005. A successful outcome from the trial would enable Evolutec to select the optimal dose of rEV131 for further planned clinical studies as part of a comprehensive development programme in allergic rhinitis. Evolutec's management believes that the allergic rhinitis market, estimated to be worth some $6 billion in the US alone, represents an attractive commercial opportunity due to the limitations of existing therapies. Many rhinitis sufferers find that oral antihistamines are ineffective against nasal congestion, which is often the most troublesome symptom, and rely instead on inhaled corticosteroids. There are concerns about the long-term use of steroids, particularly in children and the elderly. Mark Carnegie Brown, Evolutec's Chief Executive, said: 'We are very pleased to receive regulatory approval for this important trial for the Company. Following positive dialogue with the FDA, and good nasal safety data relating to rEV131, the IND allows a more comprehensive clinical study regarding the efficacy of different doses of rEV131.' For further information: Evolutec 01865 784070 Mark Carnegie Brown, Chief Executive Officer Nicholas Badman, Chief Financial Officer www.evolutec.co.uk Collins Stewart 020 7523 8350 Chris Howard Buchanan Communications 020 7466 5000 Mark Court/Tim Anderson/Mary-Jane Johnson Notes for Editors: About Evolutec Evolutec, which is based in Oxford, UK, is a clinical stage biopharmaceutical company with a focus on allergy, inflammation and autoimmune diseases. The Company's lead product, rEV131, is a histamine-binding protein that has progressed to Phase II trials in allergic conjunctivitis, rhinitis and ocular inflammation. Positive pre-clinical data has also been generated in asthma. rEV131 is understood to be the only product currently in clinical trials that impacts the recently discovered H4 receptor, a receptor implicated in many forms of inflammatory disease. The Company intends to carryout proof of concept Phase II clinical trials with rEV131 in allergic rhinitis and post-cataract surgery in 2005. The Company has two further products in pre-clinical development: rEV598, which is being evaluated in carcinoid syndrome and CINV (chemotherapy-induced nausea and vomiting), and rEV576, a complement inhibitor. Evolutec was founded in 1998 to exploit research carried out by the Natural Environment Research Council. Evolutec's drugs were first isolated from the saliva of ticks. The tick remains undetected by its hosts, including humans, by injecting an array of molecules into the skin that suppresses normal defence mechanisms. These stealth molecules have evolved over millions of years to enable the tick to take a blood meal from its host. Evolutec employs the tick's evolutionary stealth technology to offer the potential of treating human diseases. Safe Harbour statement: this news release may contain forward-looking statements that reflect the current expectations of the Company regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock Exchange
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