Phase II Trial of AVAC™ in Childhood Eczema
Genesis Research and SR Pharma Initiate Phase II Trial of AVAC™ in Childhood Eczema
Genesis Research and Development Corporation (NZX/ASX: GEN) and its partner, London-based biopharmaceutical company SR Pharma (LSE: SPA) today announced the commencement of a randomised, placebo-controlled Phase II trial of AVAC™ in paediatric atopic dermatitis (childhood eczema).
This trial, which will involve 120 children aged from 5 to 16 years, will be conducted in Auckland. Each participating child will be randomly allocated to one of two treatment groups, and will receive three injections of either AVAC or placebo, at intervals of two 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™ (a heat-killed Mycobacterium vaccae suspension) 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 at the end of 2004.
“This new AVAC Phase II trial follows on from our recent successful Phase I safety trial in children,” says Genesis CEO, Dr Jim Watson. 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.”
Atopic diseases comprise atopic dermatitis, asthma and allergic rhinitis. An atopic individual is likely to experience symptoms of one or more of these conditions from an early age and this may persist for lengthy periods during their lifetime.
Importantly, the prevalence of atopic disease in the western world has tripled over the past 30 years. It has been postulated that this increase in prevalence is causally related to a marked reduction in the incidence of infectious diseases experienced in these communities over that period.
Atopic dermatitis is estimated to affect 10–20 percent of children at some point during childhood and represents the commonest inflammatory skin disease of childhood. Sixty million people suffer from atopic dermatitis in Europe and the USA. The prevalence in seven year olds was recently reported as 16 percent in Northern Europe and 22.7 percent in Singapore.
Founded in 1994, Genesis is a New Zealand based biotechnology company with 140 staff. It is committed to the building of a broad genomic platform for the development of innovative products in health and plant biotechnology. Genesis partners with industry leaders to develop products that have global market potential through the mining of its extensive microbe, plant and mammalian EST databases.
The Health Division focuses on the immune system and has two programmes in human clinical development for the treatment of psoriasis and atopic dermatitis (eczema), with additional programmes for cancer and other indications in pre-clinical development. The patented BioStore solutions for storage of tissues and living cells are also in pre-clinical development. Collaborations are maintained with Amgen Inc. (Nasdaq: AMGN), Corixa Corporation (Nasdaq: CRXA), SR Pharma (LSE: SPA), Jurox Pty Ltd, and EvoGenix Pty Ltd.
The Plant Sciences division is focusing on key cell signalling genes – novel hormones and transcription factors - to control commercial traits including growth rates and wood fibre quality in trees, nutritional content of forage grasses, flowering control and stress tolerance. It has research collaborations with ArborGen, LLC, Wrightson Ltd (NZX: WRI), HortResearch, AgResearch and Landcare. Genesis is also undertaking significant unpartnered research programmes in novel plant hormones.
The company has an extensive health and plant patent portfolio.
For more information, please visit www.genesis.co.nz
About SR Pharma
SR Pharma plc 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. Additional
information can be found on the company’s website at