SOURCE: Evolutec Group PLC

September 20, 2005 02:01 ET

Evolutec Group Plc announces Positive Phase II Clinical Result for rEV131 In Seasonal Allergic RHiNITIS (Hay Fever)

Reading, UK -- (MARKET WIRE) -- September 20, 2005 --

For immediate release                                  20 September 2005

                          EVOLUTEC GROUP PLC
                       ("Evolutec" or "Company")


   Trial meets primary endpoint; rEV131 shows efficacy and rapid onset 
      of action Conference call for analysts today at 3pm BST

Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel products for the treatment of allergic, inflammatory and autoimmune diseases, is pleased to announce, ahead of schedule, a positive clinical trial result for its lead molecule, rEV131, in a 112 patient Phase II study in allergic rhinitis (hay fever).

rEV131 is a recombinant version of a naturally occurring molecule identified in ticks, parasites whose saliva contains immuno-suppressive and immuno-modulatory molecules over which Evolutec has strong patent protection.

This Phase II dose-ranging nasal allergen challenge study of rEV131 administered as a nasal spray was undertaken at two centres in San Antonio, Texas, under the leadership of Dr Paul Ratner. The trial was conducted in accordance with the Food & Drug Administration's Guidance for Industry recommendations.

The trial comprised four cohorts of 20 patients (16 active, 4 placebo), with the active patients on ascending single doses of rEV131, followed by a fifth cohort of 32 patients (16 active, 16 placebo) at the optimum dose. The ragweed pollen extract was administered 30 minutes after dosing.

The trial met its primary endpoint, a statistically significant difference (p< 0.05) in the mean sum of symptom scores at 15 minutes post allergen challenge in the 62 patients who completed the trial according to the protocol. rEV131 showed a dose dependent drug effect enabling Evolutec to select the optimum dose for further work to determine the onset of action and the duration of effect. There were no significant adverse events and rEV131 was comfortable and well-tolerated.

This result shows that rEV131 has an onset of action of 45 minutes or less - quicker than steroid nasal sprays which have an onset of action of approximately 8 hours. The main effects of rEV131 were against congestion and mucus production, symptoms that patients find the most troublesome and which are not well addressed by oral antihistamines. The rapid onset of action and efficacy against congestion and mucus underpin the potential commercial advantages of rEV131.

Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: "This result highlights the potential of rEV131 in the $6 billion allergic rhinitis market. We now intend to undertake a multi-dose Phase II study to define further the onset and duration of action which will guide commercial positioning. We will also continue our dialogue with potential partners."

Dr. Paul Ratner, principal study investigator and Fellow of the American Academy of Asthma, Allergy & Immunology, commented: "I am excited about the prospect of a novel therapeutic agent for the treatment of allergic rhinitis that is safe, effective within 45 minutes and delivered via the intranasal route."


Conference call:

A conference call for analysts will be held at 3.00pm BST today to discuss the result. The principal study investigator, Dr. Paul Ratner, will join the call.

  Dial-in details:
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For further information:

  Evolutec                                               0118 922 4480
  Mark Carnegie Brown, Chief Executive Officer
  Nicholas Badman, Chief Financial Officer

  Robert W. Baird                                        020 7488 1212
  Shaun Dobson/Xavier de Mol
  Buchanan Communications                                020 7466 5000
  Mark Court/Tim Anderson/Mary-Jane Johnson

Notes for Editors:

About Evolutec

Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceutical company with a focus on allergy, inflammation and auto-immune diseases.

The Company has just completed a positive 112 patient proof of concept Phase II clinical trial with rEV131, its lead product, in allergic rhinitis. The company had previously demonstrated clinical activity against the symptoms of rhinitis when rEV131 was delivered as an eye drop. Evolutec intends to carry out additional proof of concept Phase II trials with rEV131 in post-cataract surgery and dry eye. Positive preclinical data has also been generated in asthma. rEV131 is a histamine binding protein and 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 has a further two molecules in preclinical development. rEV576, a complement inhibitor which was very effective in a preclinical model of myasthenia gravis, and rEV598, which is being evaluated in carcinoid syndrome and CINV (chemotherapy-induced nausea and vomiting). Evolutec is working with Merial to develop anti-tick and anti-tick borne disease vaccines.

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 but are now manufactured by bacterial fermentation procedures. 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.

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