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31 March 2004
Auckland, New Zealand, 31 March 2004 – Genesis Research and Development Corporation (NZX/ASX:GEN) today announced that a Phase II trial of its childhood eczema therapeutic candidate, AVAC™, has reached the 50 percent enrolment milestone. The randomised, placebo-controlled trial will enrol 120 children aged from 5 to 16 years who suffer from childhood eczema, or paediatric atopic dermatitis. It commenced in October 2003 and is being conducted across the Auckland and South Auckland regions under the direction of Professor Innes Asher and Dr Wendy Walker with The University of Auckland, Kidz First and Starship providing clinical and research expertise. Children from hospital clinics, general practice and the community have been invited to take part in the study. Each participating child is randomly assigned to one of two groups, and receives three injections of either AVAC or placebo, at intervals of two weeks. The trial is designed to assess the efficacy of AVAC as a treatment, and follows a Phase I study which showed that the treatment was well tolerated. “Atopic eczema is the most common inflammatory skin disease affecting children in New Zealand,” says Professor Asher. “Around 15 percent of children are affected and its incidence is even higher in some other countries. Moreover, symptoms can persist for lengthy periods during the sufferer’s lifetime.” The study team plans to enrol another 60 participants. Parents who are interested in allowing their children to participate in the trial should contact the study co-ordinators at (09) 276 0044 ext. 2948. The New Zealand trial of AVAC is part of a two-pronged approach to the treatment of childhood eczema, and is being run in parallel with a Phase II trial of another candidate, SRP 299, which is currently underway in the United Kingdom. Genesis and SR Pharma, a London based biopharmaceutical company, have joint rights to the two products being trialled. The results of both the New Zealand and the UK Phase II trials are expected to be available at the end of 2004. “We are delighted with the progress of our AVAC Phase II trial to date,“ says Genesis CEO, Dr Jim Watson. “Reaching this recruitment milestone is a testament to the hard work and dedication of the study investigators and their team. The results from this trial will allow us to accurately determine any benefits resulting from AVAC treatment of children with eczema.” About atopic diseases Atopic diseases comprise atopic eczema, 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 his or her lifetime. Importantly, the prevalence of atopic disease in the western world has more than doubled 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. About Genesis Founded in 1994, Genesis is a New Zealand-based biotechnology company. It has built a broad genomic platform and has multiple product candidates in development, targeting immune disorders and cancer. These are backed by an extensive patent portfolio. Collaborations are maintained with Amgen Inc. (Nasdaq:AMGN), Corixa Corporation (Nasdaq:CRXA), SR Pharma plc (LSE:SPA), Jurox Pty Ltd, and AgResearch. AgriGenesis Biosciences Ltd is a wholly owned subsidiary of Genesis that is focused on using key plant 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 cold tolerance. It has developed comprehensive plant EST databases including the world’s largest EST database for commercial forestry species. It has commercial collaborations with ArborGen LLC, Wrightson (NZX: WRI), HortResearch, and Landcare Research. For more information, please visit www.genesis.co.nz Media contacts: Dr J Watson, Chief Executive, Genesis Research and Development Corporation Limited, +64 9 373 5600 Allan Botica, Botica Butler Raudon, +64 9 303 3862, +64 21 400 500, allanb@bca.co.nz |