Jul 22 2008
Anadis Ltd, a biopharmaceutical company focused on research, development and production of immune milk (colostrum)-derived polyclonal antibodies and other proteins to address major diseases, today announces the initiation of a clinical trial with top clinical scientists at Tel Aviv Sourasky Medical Center in Israel.
The clinical trial will explore the efficacy of a formulation developed by Anadis to address the symptoms of Inflammatory Bowel Disease (IBD), a serious chronic condition effecting millions of persons annually.
About 4 million people worldwide suffer from Inflammatory Bowel Disease, split roughly evenly between the two manifestations of the disease: Crohn's disease (CD) and ulcerative colitis (UC). IBD is a relapsing / remitting chronic disease with gastrointestinal symptoms such as diarrhoea, rectal bleeding and abdominal pain.
The study is led by a leading Israeli Gastroenterologist, Professor Zamir Halpern, Deputy Director of Tel Aviv Sourasky Medical Center and Chief of the Center's Gastroenterology Institute, and by Professor Nachum Vaisman, Head of the Unit of Clinical Nutrition.
The first patients have already been recruited and have entered the trial which is expected be completed during 2009. The trial is designed as an open study being run to confirm and expand upon human clinical data obtained from a pilot study at St Vincent's Hospital in Melbourne, which ended recently. Anadis intends to launch its colostrum-derived product as a medical food or nutritional immediately following the Tel Aviv trial. Anadis will meet all regulatory requirements during the conduct of the trial itself.
In addition to the initiation of this IBD study, Anadis recently announced being awarded a VISTECH grant for another study, also to be conducted at Tel Aviv Souraski Medical Center, towards the development and commercialization of a product to address cancer-related mucositis. See "Anadis Awarded VISTECH grant for Clinical Trial of Polyclonal Antibodies for the Treatment of Cancer Related Mucositis" - Tuesday 1 July 2008."
Tel Aviv Sourasky Medical Center (TASMC) is one of the largest hospitals in Israel with 1100 beds and is responsible for providing specialty care to the Tel Aviv metropolitan area. It is a teaching and research center affiliated with the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Dr Oren Fuerst, VP Business development of Anadis stated, "This is another illustration of the successful collaboration between Anadis and the researchers at TASMC. The leveraging of Australian manufacturing and core research, with research and clinical studies in Israel will allow us to bring products to market faster and at lower costs than otherwise. Our current plans calls for commercialization of both the IBD and the mucositis products within less than 2 years, addressing two major gastrointestinal diseases using our core platform."