Ph II Cataract Trial Starts
Evolutec Group PLC
20 June 2006
For immediate release 20 June 2006
EVOLUTEC GROUP PLC
('Evolutec' or 'the Company')
COMMENCEMENT OF PHASE II TRIAL IN THE TREATMENT OF INFLAMMATION FOLLOWING
CATARACT SURGERY
Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel
products for the treatment of allergic, inflammatory and autoimmune diseases, is
pleased to announce the commencement of a 150 patient proof of concept Phase II
trial with its lead compound, rEV131, against inflammation following cataract
surgery. The trial will compare the anti-inflammatory effects of rEV131 versus
prednisolone, the current standard of care, and placebo in post-operative
inflammation of the anterior segment of the eye.
This randomised double-blind trial is being co-ordinated by Ophthalmic Research
Associates ('ORA'), Boston, Massachusetts, under the leadership of Dr Mark B.
Abelson, MD. The trial will take place at 10 ophthalmic surgical centres across
the US. This trial follows a successful preclinical study showing rEV131 to be
as effective as prednisolone 1.0%, a corticosteroid.
rEV131, dosed twice a day, will be compared with prednisolone, dosed four times
a day over a two week period. The primary endpoints of the trial are flare and
cell counts, which are accepted by the US Food and Drug Administration ('FDA')
for measuring inflammation in the anterior chamber of the eye.
The Company believes the value of the post-cataract surgery inflammation market
to be approximately $500 million.
Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: 'The start
of this trial follows the commencement of a 300 patient Phase IIb trial of
rEV131 in allergic rhinitis (hay fever) as announced earlier this month. This
added momentum represents a step change in Evolutec's news flow with both trial
results anticipated by the end of 2006.'
ENDS
For further information:
Evolutec 0118 922 4480
Mark Carnegie Brown, Chief Executive Officer
Nicholas Badman, Chief Financial Officer
www.evolutec.co.uk
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 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. 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 2006/7. Following positive preclinical data, Evolutec
intends to carry out a Phase I trial of rEV131 in asthma in 2007.
The Company has a further two product development candidates in pre-clinical
development: rEV576, a complement inhibitor, and rEV598, which is being
evaluated in CINV (chemotherapy-induced nausea and vomiting). rEV576 has
demonstrated preclinical activity against the autoimmune disease myasthenia
gravis and in acute myocardial infarction ('AMI') (heart attack). Evolutec has
a research collaboration with Case Western Reserve University, Cleveland, Ohio,
to carry out further preclinical testing of rEV576 in myasthenia gravis.
The rights to Evolutec's vaccine technology for animals are partnered with
Merial, which 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.
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.
This information is provided by RNS
The company news service from the London Stock Exchange