Evolutec Group PLC
14 December 2006
Thursday 14 December 2006
Evolutec Group plc
('Evolutec' or 'the Company')
Review confirms rEV131 allergic rhinitis result
Phase II post-cataract inflammation result expected in January 2007
Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel
products for the treatment of allergic, inflammatory and autoimmune diseases,
announces that it has completed its quality assurance review of the recently
conducted allergic rhinitis clinical trial. The review confirmed that the rEV131
drug product and the implementation of the protocol were as specified.
The recent Phase IIb trial represented a higher hurdle, with patients being
exposed to much greater levels of ragweed pollen than in the previous Phase IIa
trial. As a result, patients showed twice the allergic symptom score than in
the previous trial. Thus the lack of efficacy observed may well have been
because the amount of histamine released exceeded the binding capacity of
rEV131. Evolutec has no plans to make further investment in rEV131 in allergic
rhinitis.
rEV131 is also in a Phase II clinical trial in post-cataract inflammation which
will report in January 2007. The study aims to demonstrate the
anti-inflammatory potential of rEV131 following cataract surgery. The trial is
placebo controlled and includes the standard of care, prednisolone, as an active
comparator. The primary endpoint of this 150 patient, dose-ranging proof of
concept trial is lack of eye inflammation two weeks after surgery. If the
results are positive, the Company intends to seek a partner for the rights to
rEV131 in ophthalmology.
Post-cataract inflammation and allergic rhinitis are separate unlinked
indications and were selected to test rEV131's efficacy as an anti-inflammatory
and anti-allergy therapeutic respectively.
Mark Carnegie Brown, Chief Executive of Evolutec, said: 'Despite the setback in
rhinitis, we remain positive about the outcome of the post-cataract study
because the pharmacokinetics and inflammatory drivers are different in this
indication. Following the clinical trial result in January, we will seek a
dialogue with shareholders to discuss our plans and business development
activities.'
Enquiries:
Evolutec 0118 922 4480
Mark Carnegie Brown, Chief Executive Officer
Nicholas Badman, Chief Financial Officer
www.evolutec.co.uk
Financial Dynamics 020 7831 3113
David Yates
Ben Brewerton
About Evolutec
Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceutical
company with a focus on allergy, inflammation and autoimmune diseases.
rEV576, the Company's second product development candidate is a complement
inhibitor which has demonstrated preclinical activity against the autoimmune
diseases myasthenia gravis and Guillain-Barre Syndrome, asthma and acute
myocardial infarction ('AMI') (heart attack). Evolutec has established a
research collaboration with Case Western Reserve University, Cleveland, Ohio, to
undertake further preclinical work with rEV576 in myasthenia gravis. The Company
expects to commence clinical trials with rEV576 in 2007.
The rights to Evolutec's vaccine technology for animals are partnered with
Merial. Merial is currently undertaking work in tick-borne diseases.
Evolutec is listed on the AIM market of the London Stock Exchange and develops
therapeutics originally 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 host immunity. These stealth molecules have
undergone millions of years of natural evolution to select a promising efficacy,
potency and safety profile. Evolutec employs the tick's evolutionary stealth
technology to offer the potential of treating human diseases.
This information is provided by RNS
The company news service from the London Stock Exchange
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