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20 September 2001
Auckland and London, 20 September 2001— Genesis Research and Development Corporation Ltd (NZSE/ASX: GEN) and SR Pharma plc (LSE: SPA), announced today the results of a Phase I safety trial, conducted in Wellington, of Genesis’ asthma immunotherapeutic AVAC™. In a blinded study, two doses of AVAC™ nasal drops were given to 19 adult volunteers with asthma, while 18 others received placebo saline drops. An additional 9 asthma subjects received three nasal doses in an open label study. Patients continued with the standard bronchodilator and corticosteroid inhalant therapies that they used to control asthma symptoms before the study commenced. The study met its primary end point of safety and tolerability. There were no serious adverse events, though local short-term nasal irritations were noted in 5 subjects. “This is the first clinical use of AVAC™, and we are pleased with the resulting safety profile in both the blinded and open label studies,” said Genesis Chief Executive, Dr Jim Watson. “A successful safety trial is a prerequisite to larger efficacy studies, and is a solid milestone on the path to developing a successful therapeutic.” The dose of AVAC™ administered in the trial did not show statistically significant reduction in asthma symptoms or asthma medication. This was expected as patients continued with therapies they used to control asthma symptoms and nasal drops were not expected to efficiently distribute AVAC through airways. The next studies would utilise a nasal spray device that can deliver a variety of AVAC™ doses into the airways. “Asthma has doubled in prevalence during the past 15 years and is increasingly being recognised as a major international public health problem” said SR Pharma Chief Operating Officer, David Kennard. Recent data from the US National Heart, Lung and Blood Institute shows continuing increases in rates of asthma-related hospitalisations, emergency department visits and deaths, especially among minority populations. About Asthma Asthma is a chronic inflammatory disorder of the airways. As a result of this inflammation, the airways become blocked or narrowed because of swelling, muscular contractions and mucous production. These effects are usually temporary, but they cause shortness of breath, breathing trouble and other symptoms. If an asthma attack is severe, a person may need emergency treatment to restore normal breathing. Triggers of asthma vary from person to person, but common ones include cold air; exercise; allergens (things that cause allergies) such as dust mites, mould, pollen, animal dust and some types of viral infections. The prevalence of asthma has increased significantly in the past decade, particularly in developed countries. In New Zealand and Australia up to 15% of teenagers have asthma symptoms. According to the World Health Organisation 100 to 150 million people around the world are asthmatic and the number is growing by 50% every decade. About Genesis Founded in 1994, Genesis is a New Zealand-based biotechnology company committed to the building of a broad genomic platform for the development of innovative products in human health and agriculture. 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 has three programs in human clinical development, with additional programs in pre-clinical development and in plant biotechnology. For more information, please visit www.genesis.co.nz About SR Pharma SR Pharma plc, a London based biopharmaceutical company founded in 1992, 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. SRL172 is being investigated as a monotherapy, combined with chemotherapy and as a vaccine adjuvant in cancer. A newer formulation, SRP 299, is in clinical development in asthma and atopic dermatitis. These products enhance the immune responses needed to combat cancer, while regulating those that mediate allergies. The Company's web site can be found on www.srpharma.com Media contacts: Dr Jim Watson, Chief Executive, Genesis Research and Development Corporation Limited, +64 9 373 5600 Thomas Lang PhD, Business Development Director, SR Pharma plc, +44 20 7307 1629 Allan Botica, Botica Conroy and Associates, +64 9 303 3862, +64 21 400 500, allanb@bca.co.nz Adam Reynolds/Takki Sulaiman, Hansard Communications.Com Ltd, +44 20 7735 9415, adam.hansard@clsholdings.com |