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Biotech / Medical : Indications -- Asthma/Allergy

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From: nigel bates9/21/2005 9:32:52 AM
   of 86
 
Evolutec / recomb. tick saliva PII from yesterday -

POSITIVE PHASE II CLINICAL RESULT FOR rEV131
IN SEASONAL ALLERGIC RHiNITIS (HAY FEVER)

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.'...
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