18th Apr 2005 07:00
Evolutec Group PLC18 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 novelproducts for the treatment of allergic, inflammatory and autoimmune diseases, ispleased to announce that it has obtained an Investigational New Drug ("IND")approval (BB-IND12264) from the US Food and Drug Administration ("FDA"). ThisIND allows Evolutec to commence a proof of concept clinical study in the US ofits lead compound rEV131 in allergic rhinitis (hay fever). This randomised double-blind Phase II trial will seek to demonstrate animprovement versus placebo in the four nasal symptoms of rhinitis: mucusproduction, congestion, sneeze and itch. rEV131 will be administered nasallyand the trial will involve the treatment of 112 patients. There will be fourcohorts of 16 patients each on ascending doses of rEV131 versus placebo,followed by an extra cohort of 16 patients versus placebo at the mostefficacious dose. The trial will take place at two centres in San Antonio,Texas, under the leadership of Dr Paul Ratner, a leading clinician in therespiratory field. The clinical phase is expected to take five months with analysis of the datacomplete by the end of 2005. A successful outcome from the trial would enableEvolutec to select the optimal dose of rEV131 for further planned clinicalstudies as part of a comprehensive development programme in allergic rhinitis. Evolutec's management believes that the allergic rhinitis market, estimated tobe worth some $6 billion in the US alone, represents an attractive commercialopportunity due to the limitations of existing therapies. Many rhinitissufferers find that oral antihistamines are ineffective against nasalcongestion, which is often the most troublesome symptom, and rely instead oninhaled corticosteroids. There are concerns about the long-term use ofsteroids, particularly in children and the elderly. Mark Carnegie Brown, Evolutec's Chief Executive, said: "We are very pleased toreceive regulatory approval for this important trial for the Company. Followingpositive dialogue with the FDA, and good nasal safety data relating to rEV131,the IND allows a more comprehensive clinical study regarding the efficacy ofdifferent doses of rEV131." For further information: Evolutec 01865 784070Mark Carnegie Brown, Chief Executive OfficerNicholas Badman, Chief Financial Officerwww.evolutec.co.uk Collins Stewart 020 7523 8350Chris Howard Buchanan Communications 020 7466 5000Mark Court/Tim Anderson/Mary-Jane Johnson Notes for Editors: About Evolutec Evolutec, which is based in Oxford, UK, is a clinical stage biopharmaceuticalcompany with a focus on allergy, inflammation and autoimmune diseases. The Company's lead product, rEV131, is a histamine-binding protein that hasprogressed to Phase II trials in allergic conjunctivitis, rhinitis and ocularinflammation. Positive pre-clinical data has also been generated in asthma.rEV131 is understood to be the only product currently in clinical trials thatimpacts the recently discovered H4 receptor, a receptor implicated in many formsof inflammatory disease. The Company intends to carryout proof of concept PhaseII clinical trials with rEV131 in allergic rhinitis and post-cataract surgery in2005. The Company has two further products in pre-clinical development: rEV598, whichis being evaluated in carcinoid syndrome and CINV (chemotherapy-induced nauseaand vomiting), and rEV576, a complement inhibitor. Evolutec was founded in 1998 to exploit research carried out by the NaturalEnvironment Research Council. Evolutec's drugs were first isolated from thesaliva of ticks. The tick remains undetected by its hosts, including humans, byinjecting an array of molecules into the skin that suppresses normal defencemechanisms. These stealth molecules have evolved over millions of years toenable the tick to take a blood meal from its host. Evolutec employs the tick'sevolutionary stealth technology to offer the potential of treating humandiseases. 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:
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