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05 March 2003
Auckland, date 5 March 2003 – Genesis Research and Development Corporation (NZSE / ASX: GEN) and SR Pharma plc (LSE: SPA) today announced the successful completion of a Phase I safety study of AVAC™ for the treatment of atopic dermatitis (also known as eczema) in children, which showed that AVAC was safe and well tolerated. This trial of AVAC for atopic dermatitis in children follows a Phase I trial in adults completed in 2002. The present study, conducted in Wellington, involved 12 children aged 5 to 16 years. All children received three intradermal injections of AVAC, at intervals of two weeks and were monitored closely for safety. Subjects were divided into four groups and were treated sequentially, with each dose group completing its assigned course of three injections before the next higher dose group commenced. Injection site reactions were the major side effect of treatment, but there were no serious adverse events reported. Although this small study was not designed to measure efficacy, clinical improvement in atopic dermatitis was noted in the majority of the children as measured by a standard scoring system for eczema. Genesis Chief Executive Dr. Jim Watson says, “We are cautiously optimistic about this result. With the Phase I safety data in hand, we can now move ahead to our planned placebo-controlled Phase II trial, scheduled to start in the second quarter of 2003. The Phase II trial will allow us to accurately determine any benefits resulting from AVAC treatment.” 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. The 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. The patented BioStore solutions for storage of tissues and living cells are also in pre-clinical development. Collaborations are maintained with Immunex (Amgen) Corporation (NASDAQ: AMN), Corixa Corporation (NASDAQ: CRXA), SR Pharma (LSE: SPA), and Jurox Pty Ltd. The Plant Sciences division is focussing 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 (NZSE: WRI), HortResearch, AgResearch and Landcare. Genesis is also undertaking significant unpartnered research programmes in novel plant hormones. For more information, please visit www.genesis.co.nz Media contacts: Dr James D Watson, Chief Executive, Genesis Research and Development Corporation Limited, +64 9 373 5600 Allan Botica, Botica Conroy and Associates, +64 9 303 3862, +64 21 400 500, allanb@bca.co.nz |