Start of AVAC phase II clinical trial
September 10 2003 - 2:01AM
UK Regulatory
SR Pharma and Genesis Research Initiate Phase II Trial of AVAC(tm)
in Childhood Eczema
London and Auckland, 10 September 2003 - London-based biopharmaceutical company
SR Pharma (LSE: SPA) and its partner Genesis Research and Development
Corporation (NZX/ASX: GEN) today announce the start of a randomised,
placebo-controlled phase II trial of AVAC(tm) in paediatric atopic dermatitis
(childhood eczema).
This trial, which aims to recruit 120 children aged from 5 to 16 years, is
being conducted in Auckland, New Zealand. Each participating child will be
randomised to one of two treatment groups and will receive 3 injections of
either AVAC or placebo at intervals of 2 weeks. The trial will assess both the
efficacy and safety of AVAC treatment. Quality of life data will also be
collected.
The New Zealand AVAC trial complements the phase II trial of SRP299 in
childhood eczema, which is currently underway in the United Kingdom. SR Pharma
and Genesis Research are jointly developing SRP299 and AVAC for the treatment
of atopic dermatitis. The results of both the New Zealand and the UK phase II
trials are expected to be available during the second half of 2004.
Dr David Hill, CEO of SR Pharma, commented: "This new AVAC phase II trial
follows on from the recent successful phase I AVAC safety trial conducted in
children. In that trial, clinical improvement in atopic dermatitis was noted in
the majority of the children as measured by a standard scoring system for
eczema. The phase II trial will allow us to accurately assess the benefits
resulting from AVAC treatment of children with eczema."
About atopic dermatitis
Atopic dermatitis, which is sometimes known as eczema, is a chronic disease in
which the skin becomes itchy and inflamed. This causes redness, swelling,
cracking, weeping, scaling and crusting. The prevalence of the disease has
tripled in the past 30 years. Atopic dermatitis is estimated to affect 10-25%
of children at some point during childhood and represents the commonest
inflammatory skin disease in children.
The prevalence in 7 year olds was recently reported as 16% in northern Europe
and 23% in Singapore. 10-15% of children retain their childhood dermatitis into
adulthood. The overall incidence in the UK has increased from 5% in 1946 to 12%
in 1970. Over 60 million people suffer from atopic dermatitis in Europe and the
USA. The disease is often associated with other allergic conditions and 40-50%
of atopic dermatitis patients will also develop asthma and/or rhinitis. The
global market size was estimated to be worth about �2 billion in 2000.
About SR Pharma
SR Pharma plc (www.srpharma.com) was founded in 1992 and is committed to
developing innovative medicines based on an improved understanding of the role
played by the immune system in combating disease.
The company's proprietary M. vaccae-based technology is the source of a number
of product developments. SRP299 is currently being evaluated for the treatment
of asthma and atopic dermatitis. The company is also investigating SRL172 as
both a monotherapy and as a vaccine adjuvant in cancer and infectious diseases.
These products enhance the immune responses needed to combat cancer and
infection, while regulating those that mediate allergies.
For further information please contact:
Steeve Lamontagne
SR Pharma plc
Tel : +44 (0) 20 7307 1628
Mobile: +44 (0) 7900 901 050
Email : s.lamontagne@srpharma.com
SR Pharma and Genesis Research Initiate Phase II Trial of AVAC(tm) in Childhood
Eczema
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