New study data
Evolutec Group PLC
23 January 2006
For immediate release 23 January 2006
EVOLUTEC GROUP PLC
('Evolutec' or 'Company')
POSITIVE PRECLINICAL RESULT FOR rEV576
IN ACUTE MYOCARDIAL INFARCTION (HEART ATTACK)
Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel
products for the treatment of allergic, inflammatory and autoimmune diseases, is
pleased to announce a positive result for its preclinical development candidate
rEV576 in acute myocardial infarction ('AMI'). In the trial, rEV576
significantly reduced damage to heart tissue (>25%) with good effect even at low
doses.
In AMI, heart muscle is damaged following coronary thrombosis and the objective
of therapy is to reduce this damage. The approved thrombolytics re-establish
blood flow following heart attack but do not address the damage to heart tissue.
There are approximately one million cases of AMI per annum in the US making this
a substantial market opportunity with unmet need.
rEV576 is a potent complement C5 inhibitor, an exciting new class of drugs that
target the complement system. Over-activation of complement is implicated in a
range of acute and chronic conditions including AMI, transplant rejection and
damage to joint surfaces in rheumatoid arthritis.
Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: 'rEV576 has
already generated considerable scientific interest and this result emphasises
its potential in acute cardiovascular indications such as AMI, stroke and
cardiopulmonary bypass. The result adds to the promising efficacy seen with
rEV576 in an acute preclinical model of the auto-immune disease myasthenia
gravis and underlines the potential of Evolutec's pipeline.'
ENDS
For further information:
Evolutec 0118 922 4480
Mark Carnegie Brown, Chief Executive Officer
Nicholas Badman, Chief Financial Officer
www.evolutec.co.uk
Bridgewell Securities 020 7003 3000
Shaun Dobson/Xavier de Mol
Buchanan Communications 020 7466 5000
Mark Court/Tim Anderson/Mary-Jane Johnson
Notes for Editors:
About the complement system and rEV576's mechanism of action
The complement system is an essential part of the body's natural defence
mechanism against foreign invasion. It is also involved in the inflammatory
process. It comprises around 20 plasma proteins, which act as enzymes or as
binding proteins, along with multiple cell-surface receptors and several
regulatory membrane proteins. When foreign material is detected, the complement
cascade is activated and locally acting chemical messengers are released.
rEV576's mechanism of action is by binding the C5 protein at the penultimate
step of the complement cascade thereby preventing the release of C5a and C5b-9
(the membrane attack complex). C5a and C5b-9 attract white blood cells and
allow them to pass through blood vessel walls into the tissue. The white blood
cells then release cytokines that destroy the tissue locally. C5 complement
inhibitors do not impact the early steps of the complement cascade which form an
important part of the human body's natural defence mechanism
Complement can be activated inappropriately under certain circumstances leading
to undesirable local tissue destruction. In ischemic stroke and myocardial
infarction, the body recognises the dead tissue in the brain and heart
respectively as foreign and activates complement so causing further local
damage. Similarly in cardiopulmonary bypass operations, the body recognises the
plastic surfaces in the machine as foreign, activates complement and this can
result in vascular damage. In autoimmune diseases, the body may wrongly
recognise itself as foreign and activate complement with local tissue damage
(e.g. joint destruction in rheumatoid arthritis and muscle weakness in
myasthenia gravis).
In September 2005, Evolutec obtained a positive preclinical result for rEV576 in
myasthenia gravis, which results in progressive fatigue, loss of muscle tone and
increasing paralysis. There is currently no cure for myasthenia gravis. In the
trial, a single dose of rEV576 completely prevented paralysis and weight loss
over a five day period.
About Evolutec
Evolutec is a biopharmaceutical company developing drugs for allergy,
inflammation and autoimmune disease.
Evolutec's lead drug candidate, rEV131 has efficacy in both acute and chronic
respiratory indications including allergic rhinitis (hay fever) and asthma. In
2005, Evolutec announced a positive result for rEV131 in a 112 patient Phase IIa
proof of concept study in allergic rhinitis. rEV131 met the primary efficacy
endpoint (p < 0.05). In addition, rEV131 showed efficacy against mucus and
congestion, the most difficult to treat symptoms of rhinitis as well as a rapid
onset of action.
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 that 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, which is based in Reading, UK, 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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