GIACONDA ANNOUNCES COMMENCEMENT OF CLINICAL TRIAL FOR HEPACONDA® IN HEPATITIS C
Sydney, Australia 25 June 2007. Giaconda Ltd (ASX: GIA) announced that a Phase IIa clinical trial of Hepaconda® for the treatment of Hepatitis C virus (HCV) genotype 1 refractory to current therapy has commenced. The study is being carried out by the Centre for Digestive Diseases and the first patient has been enrolled in the trial and begun treatment.
The current standard treatment for chronic HCV has limited efficacy, especially in genotype 1 and poor tolerability with the result that many patients cease treatment. Genotype 1 Hepatitis C virus has the lowest response rate to standard treatment compared to other genotypes and carries a higher risk of post-treatment relapses and progression to liver cirrhosis and liver cancer.
Hepaconda® is a combination of bezafibrate and chenodeoxycholic acid, both of which have demonstrated activity against HCV as single compounds. Giaconda believes that the combination of bezafibrate, with chenodeoxycholic acid may offer a synergistic advantage over current treatment.
The clinical trial is a two centre, open label, prospective study of the efficacy and safety of the combination of chenodeoxycholic acid and bezafibrate in the treatment of subjects diagnosed with Hepatitis C Virus genotype 1, who have failed standard therapy (peg-interferon and Ribavirin combination therapy).
The primary endpoints of the trial are to obtain a virological response and a reduction in viral load at 3 months and 6 months. The secondary objectives are to obtain clinically significant improvements in elevated liver function tests at 3 and 6 months and to obtain an acceptable safety profile. Subject to recruitment, it is anticipated that the trial will finish by the end of 2007 and that results will be made available in 2008. (Further details in the Appendix 1)
“Hepatitis C is a significant health issue across the globe and a significant number of patients fail conventional treatment,” said Professor Tom Borody, Chief Medical Officer of Giaconda.
“We are committed to developing an alternative for these patients and we believe that Hepaconda® may offer such an alternative.”
About Giaconda Limited
Giaconda Limited is a biotechnology company involved in developing and licensing innovative and cost effective medical therapies in the field of gastroenterology. Giaconda’s products are targeted towards the treatment of serious conditions that are not adequately addressed by any existing therapy. In this way, Giaconda’s products are intended to satisfy these significant unmet medical needs of the gastrointestinal market. The Giaconda portfolio consists of five products, all of which are novel combinations of known compounds. Giaconda has two lead products, Myoconda® for the treatment of Crohn’s Disease and Heliconda® for the treatment of resistant Helicobacter pylori infection. Both of these products are ready for Phase III clinical trials, with a Phase IIIa already complete for Myoconda®.
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GIACONDA APPOINTS NEW CHIEF OPERATING OFFICER
Sydney, Australia. 7 May 2007. Giaconda Limited (ASX: GIA) today announced that Kirrilli Parker has been appointed Chief Operating Officer due to the departure of Rosa Surace who is pursuing other interests.
Kirrilli Parker has been with Giaconda since November 2005 and prior to this appointment held the role of Chief Administrative Officer and Company Secretary. She will continue her role as Company Secretary in addition to her new responsibilities as Chief Operating Officer.
Kirrilli completed a Bachelor of Science at Macquarie University and a Masters of Commerce at Sydney University. She joined the biotechnology industry in 2003 with Sienna Capital Limited. As Executive Officer at Sienna she was responsible for corporate administration and assisting the CEO with project management of the research, development and commercialisation of technology from the Ludwig Institute for Cancer Research. Kirrilli completed the Graduate Diploma of Applied Corporate Governance through the Chartered Secretaries of Australia in 2005 and is an Associate member.
“We believe that Kirrilli will continue her excellent work in her new role,” said Patrick McLean, CEO of Giaconda.
“As a member of Giaconda’s team she has already made considerable contributions to the company and her expertise will remain an asset to us. I would also like to thank our outgoing Chief Operating Officer, Rosa Surace, for all her support and dedication and we wish her well.”
About Giaconda Limited
Giaconda Limited is a biotechnology company involved in developing and licensing innovative and cost effective medical therapies in the field of gastroenterology. Giaconda’s products are targeted towards the treatment of serious conditions that are not adequately addressed by any existing therapy. In this way, Giaconda’s products are intended to satisfy these significant unmet medical needs of the gastrointestinal market. The Giaconda portfolio consists of five products, all of which are novel combinations of known compounds. Giaconda has two lead products, Myoconda® for the treatment of Crohn’s Disease and Heliconda® for the treatment of resistant Helicobacter pylori infection.
More information is available on the website www.giacondalimited.com
Except for historical information, this news release may contain forward-looking statements that reflect the Company’s current expectation regarding future events. These forward looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
