Phase II trial of SRP299 in childhood eczema

Genesis and SR Pharma initiate phase II trial of SRP299 in childhood eczema

Genesis Research and Development Corporation (NZSE/ASX: GEN) and London-based biopharmaceutical company SR Pharma (LSE: SPA), today announced the start of a phase II, randomised, placebo-controlled, trial of SRP299 (a killed Mycobacterium vaccae suspension) for the treatment of moderate-to-severe atopic dermatitis (eczema) in children aged 5 to 16. SR Pharma and Genesis are jointly developing SRP299 together with AVAC™ for the treatment of atopic dermatitis.

The trial, which aims to recruit 120 evaluable patients, will be conducted in ten research centres across the United Kingdom and Ireland. The trial will evaluate the effects of SRP299 on the extent and severity of atopic dermatitis, and assess the duration of action of SRP299 and patients’ quality of life. The trial will also monitor the safety and tolerability of SRP299. Each patient will be randomised to one of three treatment arms and will receive a single injection of either a standard dose SRP299, a low dose of SRP299 or placebo.
“This trial provides an excellent opportunity for Genesis and SR Pharma to evaluate the efficacy and safety of SRP299 in children suffering from moderate-to-severe eczema,” said Dr. Jim Watson, Chief Executive of Genesis Research and Development. “SRP299 is already being evaluated in the treatment of mild-to-moderate asthma. This additional study represents an important milestone in the development of SRP299 as a novel treatment for the management of atopic dermatitis.”

Results from a previous trial conducted by Dr. Peter Arkwright of Booth Hall Children’s Hospital in Manchester reported that treatment with killed M. vaccae significantly improved the symptoms of children aged between 5 and 18 years and suffering from moderate-to-severe atopic dermatitis. Three months after treatment those children given a single dose of M. vaccae showed a mean 48 percent reduction in surface area affected by dermatitis, compared with 4 percent in placebo group (p < 0.001). A median 68 percent reduction in dermatitis severity score, compared with 18 percent for placebo group was also observed (p < 0.01).

SR Pharma is expecting the results of this new trial to be available during 2004.

Genesis and SR Pharma have two other atopic dermatitis trials underway. In July, Genesis commenced a phase I paediatric trial to assess AVAC tolerability in children with atopic dermatitis. Results for the open-label study, being undertaken in Wellington, are expected in early 2003. SR Pharma is also conducting a paediatric trial in the UK with M. vaccae involving 60 children with atopic dermatitis. The results of this study will be available mid 2003.

ENDS

About atopic diseases

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% of children at some point during childhood and represents the commonest inflammatory skin disease of childhood. 60 million people suffer from atopic dermatitis in Europe and the USA. The prevalence in 7 year olds was recently reported as 16% in Northern Europe and 22.7% in Singapore. The overall incidence in the UK has increased from 5% in 1946 to 12.2% in 1970.

About Genesis

Founded in 1994, Genesis is a New Zealand-based biotechnology company committed to the development of innovative products in health and plant biotechnology from its broad genomic platform. 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.

Genesis’ Health Sciences Division focuses on signalling pathways involved in immune diseases and cancer and has an extensive patent portfolio. It has three programmes in human clinical development utilising PVAC™ and AVAC™ for the treatment of psoriasis, atopic dermatitis (eczema) and asthma. Additional pre-clinical programmes are developing YB-1, FGFR5 and Epigen as targets for treatment of cancer and immune mediated diseases. 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), and Jurox 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, salt and cold tolerance. It has developed comprehensive plant EST databases including the world’s largest EST database for commercial forestry species. It has research collaborations with ArborGen LLC, Wrightson (NZSE: WRI), HortResearch, AgResearch and Landcare. Genesis is also undertaking significant unpartnered research programmes in novel plant hormones. A number of patents are held including 12 steps in the production of lignin.

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. SR Pharma is currently evaluating SRP299 and AVACTM 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 www.srpharma.com

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