CBio Limited


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	XToll® - an attractive pharmaceutical asset XToll® is a drug therapy discovered and developed in Australia for the treatment of human autoimmune diseases, including rheumatoid arthritis (RA). RA is a chronic, debilitating and progressive disease that leads to pain, suffering and disability. It affects up to 2% of the world’s population. CBio will initially target its lead product, XToll®, for development as a potential RA therapy. The Directors believe XToll® may also be useful in multiple disease states. Existing RA therapies generate significant income for global pharmaceutical companies - the top three therapies alone generated sales of approximately US$10.9 billion in 2008. Data supports the view however that up to 30-40% of patients do not respond satisfactorily to these leading treatments.3 In addition, safety issues and side effect profiles present concern. The efficacy and safety profile of XToll®, demonstrated in clinical trials completed to date, shows potential to reach or exceed current therapies; and with data suggesting a different mechanism of action to existing drugs and drugs currently under development by other companies, XToll® will potentially target both responders and non-responders to current treatments. With multiple patents already granted or granted under licence to CBio, including the composition of matter patent covering the key US market, XToll® will, once remaining patents are granted, have patent protection to at least 2023 with a potential extension to 2028 in most jurisdictions. Further, it is believed that the manufacturing cost of goods for XToll® will be comparatively low compared with leading treatments available today. These advantages combine to make XToll® a potentially attractive pharmaceutical asset. Successful completion of the current Phase II study and other prioritised activities in the clinical development program will maximise the prospect of the licensing or sale of XToll® to a major pharmaceutical company – providing potential upside and return to shareholders. The Development Timeline of XToll® 1994 – University of Queensland, the inventor of the Cpn10 technology, submitted the first patent application around the technology – which was subsequently granted 2000 – CBio in-licensed Cpn10 technology 2002 – Established its first dedicated laboratories in Brisbane 2003 – Commenced and completed first phase I clinical trial in 19 human volunteers 2004 - Commenced and completed first phase Ib clinical trial in 12 patients with MS 2004 – Awarded two Australian Federal Government grants (Linkage Grants) to fund further development of XToll® 2005 – Commenced phase II clinical trials with intravenous administration in RA, psoriasis and MS 2005 – Needing to expand, CBio moved to purpose built facility in Brisbane Technology Park 2005 – Granted $6 million funding over four years under the Federal Government Pharmaceutical Partnerships Programme (P3) 2005 – Commenced phase I subcutaneous dosing clinical trial in 46 human volunteers 2006 - Completed three phase IIa trials in RA (23 patients), psoriasis (24 patients), and MS (50 patients) with good safety demonstrated and determination of clear clinical efficacy RA and psoriasis 2006 – Published RA clinical trial data in medical journal, The Lancet 2006 – Completed phase I intravenous administration studies of XToll® in 46 humans. In these studies, biological action was noted with no evidence of a pattern of serious adverse events 2007 – Commenced pre-clinical studies to support planned Phase IIa subcutaneous dosing RA clinical trial 2007 – Completed six supportive toxicology studies in two species to support the clinical program 2007 – Dr Goran Ando, Dr Peter Corr and Professor John Funder join the Board of CBio 2007 – Completed the first stage of a four-stage programme for commercial scale production of Cpn10 with leading global commercial manufacturing organisation, Boehringer Ingelheim 2008 – Entered into a commercial agreement with Novo Nordisk A/S for the development of XToll® 2008 - Commenced 150 patient phase IIa subcutaneous dosing RA clinical trial 2008 – Composition of matter patent granted in Australia, New Zealand and Singapore 2009 – Composition of Matter patent granted in the United Sates, China and India. 2010 - CBio lists on the ASX 2011- CBio completes phase IIa RA clinical trial and received final report.