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21 December 2004
Auckland, New Zealand, 22 December 2004 – Genesis Research and Development Corporation (NZX/ASX:GEN) today announced that the Phase II trial of its childhood eczema therapeutic candidate, AVAC™, failed to meet the primary efficacy endpoint of improving eczema symptoms compared to placebo. The AVAC paediatric atopic dermatitis programme will be terminated. The primary measure of treatment efficacy was the change in SASSAD (six-area six-sign atopic dermatitis) score, an indicator of eczema severity. Analysis of the data showed that there was no statistically significant difference in SASSAD improvement between the placebo and AVAC-treated patient groups. Both treatments were safe and well-tolerated. Stephen Hall, CEO of Genesis, commented, “The result of the trial is clearly disappointing, but will not have a significant impact on the company, which is focusing on the development of an RNAi therapeutic for asthma and atopic dermatitis.” Mr Hall noted that the AVAC trial had been conducted to an extremely high standard, meeting very challenging timelines, and was a credit to the study team members. The trial was led by Professor Innes Asher and Dr Wendy Walker, with The University of Auckland, Kidz First and Starship contributing clinical and research expertise. “We recognise that clinical trials involving children require special planning, and that the expertise of the study team has been crucial to the successful completion of the trial on schedule.” “We value the experience we have gained in taking a second product from discovery through pre-clinical and early clinical development, to Phase II clinical trial. The pre-clinical testing systems and disease models now in place at Genesis are already proving very useful for our RNAi programme. In addition, by carrying out our own Phase II trial in New Zealand we have confirmed Genesis’ ability to conduct high quality early phase clinical trials.” This randomised, blinded, placebo-controlled trial studied 128 children aged from 5 to 16 years who suffered from childhood eczema. All except four completed the six-month period of clinical assessment. The trial started in September 2003, full enrolment was achieved by the end of June 2004, and the last patient assessment was conducted in December 2004. About Genesis Founded in 1994, Genesis is a New Zealand-based biotechnology company. It has built a broad therapeutic development platform targeting immune disorders and cancer. This has resulted in 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 flowering control, cold tolerance, growth rates and cell-wall lignin and cellulose content in commercial species. 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: Stephen Hall, 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@botica.co.nz |