Research Update
16 November 2006 - 8:01AM
UK Regulatory
RNS Number:1543M
Evolutec Group PLC
16 November 2006
Thursday 16 November 2006
Evolutec Group plc
("Evolutec" or "the Company")
Clinical Trial Update
Phase II Post-cataract Eye Inflammation Trial is Fully Recruited
Results Expected Early 2007
Evolutec (AIM: EVC), the biopharmaceutical company developing novel products for
the treatment of allergic, inflammatory and autoimmune diseases, announces that
its proof of concept Phase II trial with its lead compound, rEV131, against
inflammation following cataract surgery is fully recruited.
With today's announcement, the Company expects the trial results to be published
early in the New Year. This is the result of an acceleration in the recruitment
of patients after Evolutec increased the number of centres participating in the
trial from 10 to 15. This updates the announcement by the Company in September
that initial recruitment of the required 150 patients had been slow and that the
trial results were likely to be delayed until H1 2007.
This randomised double-blind trial is being co-ordinated by Ophthalmic Research
Associates ("ORA"), North Andover, Massachusetts, under the leadership of Dr
Mark B. Abelson, MD. It will compare the anti-inflammatory effects of rEV131
versus placebo and the steroid prednisolone. Prednisolone is the most widely
prescribed treatment for post-operative inflammation of the anterior segment of
the eye.
rEV131, dosed twice a day, will be compared with prednisolone, dosed four times
a day over a two week period. The primary endpoint of the trial is inflammation
at 14 days.
This trial follows a successful preclinical study showing rEV131 to be as
effective as prednisolone. The Company believes the value of the post-cataract
surgery inflammation market to be approximately $500 million.
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
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 completed a positive 112 patient proof of concept Phase IIa
clinical trial with rEV131, its lead product development candidate, in allergic
rhinitis. rEV131 met the primary endpoint of reducing the sum of symptom scores
at statistically significant levels within 45mins of administration. rEV131 is
currently being evaluated in a 300 patient Phase IIb clinical trial in allergic
rhinitis which is expected to report by the end of 2006. In addition to the
Phase IIb trial in rhinitis and the proof of concept Phase II trial in
post-cataract, Evolutec also intends to complete a proof of concept Phase II
trial in dry eye in 2007. Following positive preclinical data, Evolutec intends
to undertake a Phase I trial with rEV131 in asthma in 2007.
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
END
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