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ActoGeniX completes manufacturing of clinical product and prepares for phase 2 clinical trial PDF

ActoGeniX completes manufacturing of clinical product and prepares for phase 2 clinical trial

Ghent, May 14, 2008 – ActoGeniX, a development stage biopharmaceutical company, announces the successful completion of Good Manufacturing Practices (GMP) compliant production of its lead therapeutic product AG011 for treatment of inflammatory bowel disease. ActoGeniX is now preparing the regulatory filing in Europe and North America, to obtain approval for a phase 2 clinical trial with AG011.

ActoGeniX is focused on the development and commercialization of ActoBiotics, a novel class of protein-based biopharmaceuticals that can be orally administered. The Company´s lead product AG011 is an ActoBiotic for treatment of inflammatory bowel disease and has previously been successfully tested in a phase 1 clinical trial with Crohn´s disease patients. ActoGeniX, together with its manufacturing partners, has now produced and formulated clinical-grade AG011 and intends to conduct a multicenter phase 2A study in ulcerative colitis patients in Europe and North America. ActoGeniX will, in the coming weeks, file the regulatory applications to obtain approval for the start of this clinical trial during this summer. ActoGeniX also plans to start a phase 2 study with the same product in Crohn´s disease patients in the course of 2009.

Dr. Mark Vaeck, CEO of ActoGeniX, stated: 'We are very pleased to have completed this important milestone in the development of our lead product AG011. We are moving ahead swiftly in the execution of our development plan with a goal to bring our innovative ActoBiotics-based therapies to patients, who are in desperate need for novel treatment options.'

ActoGeniX is building a broad and diverse portfolio of ActoBiotics for the treatment of severe diseases with high medical need, including inflammatory bowel disease, mucositis, allergic asthma and diabetes.