Ph IIb Hay Fever Trial Starts
Evolutec Group PLC
13 June 2006
For immediate release 13 June 2006
EVOLUTEC GROUP PLC
('Evolutec' or 'the Company')
COMMENCEMENT OF PHASE IIb ALLERGIC RHINITIS (HAY FEVER) TRIAL
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 300 patient Phase IIb trial of rEV131
in allergic rhinitis. This follows receipt of an unconditional 'No Objection
Letter' from Health Canada, the Canadian regulatory authority.
This multi-dose double-blind trial is being undertaken by Allied Research
International ('Allied') in Toronto, Canada, under the leadership of Dr. Pyush
Patel. This trial aims to build on the commercial differentiation of rEV131
from existing therapies and follows Evolutec's Phase IIa single dose study which
demonstrated the rapid onset of action of rEV131 in a nasal allergen challenge
format.
In particular, this study will determine the duration of action of rEV131, which
is being administered as a nasal spray. The trial will be conducted using
Allied's Environmental Exposure Chamber in which patients will be exposed to
high levels of ragweed pollen for periods in excess of 12 hours. The primary
endpoint of the trial is the sum of symptom scores after 7 days of twice daily
dosing.
There are some 35 million allergic rhinitis patients in the US alone and the US
allergic rhinitis market is estimated to be worth in excess of $6.6 billion.
Surveys indicate that more than 70% of patients in the US are interested in
adopting new treatments, one reason for which is patients' desire to move away
from steroid-based medications.
rEV131 is a recombinant derived from a naturally occurring molecule identified
in ticks, parasites whose saliva contains immuno-suppressive and
immuno-modulatory molecules over which Evolutec has strong patent protection.
Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: 'The start
of this pivotal trial and the result, expected by the end of this calendar year,
are important milestones in the commercialization of rEV131.'
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. Evolutec
intends to complete proof of concept Phase II trials in post-cataract surgery in
2006 and dry eye in 2006/7. Positive pre-clinical data has also been generated
in asthma. Through binding histamine, rEV131 has a unique product profile with
effects on both early and late stage inflammation.
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 carryout further preclinical testing of rEV576 in myasthenia gravis.
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 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