Rhinitis IND
Evolutec Group PLC
18 April 2005
For immediate release 18 April 2005
EVOLUTEC GROUP PLC
('Evolutec' or 'the Company')
FDA approval to commence
proof of concept trial in allergic rhinitis in the US
Evolutec Group plc (AIM: EVC), a biopharmaceutical company developing novel
products for the treatment of allergic, inflammatory and autoimmune diseases, is
pleased to announce that it has obtained an Investigational New Drug ('IND')
approval (BB-IND12264) from the US Food and Drug Administration ('FDA'). This
IND allows Evolutec to commence a proof of concept clinical study in the US of
its lead compound rEV131 in allergic rhinitis (hay fever).
This randomised double-blind Phase II trial will seek to demonstrate an
improvement versus placebo in the four nasal symptoms of rhinitis: mucus
production, congestion, sneeze and itch. rEV131 will be administered nasally
and the trial will involve the treatment of 112 patients. There will be four
cohorts of 16 patients each on ascending doses of rEV131 versus placebo,
followed by an extra cohort of 16 patients versus placebo at the most
efficacious dose. The trial will take place at two centres in San Antonio,
Texas, under the leadership of Dr Paul Ratner, a leading clinician in the
respiratory field.
The clinical phase is expected to take five months with analysis of the data
complete by the end of 2005. A successful outcome from the trial would enable
Evolutec to select the optimal dose of rEV131 for further planned clinical
studies as part of a comprehensive development programme in allergic rhinitis.
Evolutec's management believes that the allergic rhinitis market, estimated to
be worth some $6 billion in the US alone, represents an attractive commercial
opportunity due to the limitations of existing therapies. Many rhinitis
sufferers find that oral antihistamines are ineffective against nasal
congestion, which is often the most troublesome symptom, and rely instead on
inhaled corticosteroids. There are concerns about the long-term use of
steroids, particularly in children and the elderly.
Mark Carnegie Brown, Evolutec's Chief Executive, said: 'We are very pleased to
receive regulatory approval for this important trial for the Company. Following
positive dialogue with the FDA, and good nasal safety data relating to rEV131,
the IND allows a more comprehensive clinical study regarding the efficacy of
different doses of rEV131.'
For further information:
Evolutec 01865 784070
Mark Carnegie Brown, Chief Executive Officer
Nicholas Badman, Chief Financial Officer
www.evolutec.co.uk
Collins Stewart 020 7523 8350
Chris Howard
Buchanan Communications 020 7466 5000
Mark Court/Tim Anderson/Mary-Jane Johnson
Notes for Editors:
About Evolutec
Evolutec, which is based in Oxford, UK, is a clinical stage biopharmaceutical
company with a focus on allergy, inflammation and autoimmune diseases.
The Company's lead product, rEV131, is a histamine-binding protein that has
progressed to Phase II trials in allergic conjunctivitis, rhinitis and ocular
inflammation. Positive pre-clinical data has also been generated in asthma.
rEV131 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 intends to carryout proof of concept Phase
II clinical trials with rEV131 in allergic rhinitis and post-cataract surgery in
2005.
The Company has two further products in pre-clinical development: rEV598, which
is being evaluated in carcinoid syndrome and CINV (chemotherapy-induced nausea
and vomiting), and rEV576, a complement inhibitor.
Evolutec 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. 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.
This information is provided by RNS
The company news service from the London Stock Exchange