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Amsterdam Molecular Therapeutics Initiates Program for Late Stage Liver Cirrhosis and Reports Strong Progress in AMT-011 With Trial Fully Recruited and European and US Submission On Track for First Half of 2008
Date:11/27/2007

of AAV engineered to carry IGF-1 were sufficient to interfere with, or even reverse fibrosis and achieve a long term effect. AAV vectors constitute the gene therapy platform of choice of Amsterdam Molecular Therapeutics.

A pilot clinical trial conducted by investigators in Pamplona, Spain and Groningen, The Netherlands in a small number of cirrhotic patients supports the importance of IGF-1 in treating cirrhosis - both an increased serum albumin and improved energy metabolism were achieved as a result of (subcutaneous) IGF-I protein administration. Because of the short half-life of IGF-1, a treatment based on the subcutaneous administration of recombinant IGF-I would require almost constant infusion and is not considered practical. The gene-therapy-mediated induction of IGF-I expression bypasses this disadvantage and shows long-term effect, as the animal studies at CIMA have shown. Clinical studies will need to confirm the long-term safety and efficacy in men.

Ronald Lorijn, CEO of AMT, said, "We are very pleased with our agreement with CIMA, which gives us access to programs that are already well-advanced and that have tremendous potential. Our technology platform seems ideally suited to develop IGF-I for the treatment of liver cirrhosis, a very serious disorder, which not only causes great human suffering, but also comes at a very high cost for society. AMT is fully dedicated and equipped to add this new program to its product pipeline and plans to start the necessary pre-clinical studies including a full toxicology program next year. We are confident to continue to leverage our close relationship with Digna and CIMA to fill our pipeline with promising products that address unmet medical needs."

Clinical Program AMT-011

The clinical development of AMT's lead product AMT-011 for the treatment of Lipoprotein Lipase Deficiency is proceeding according to plan. All patients have been recruited in the Canadian study. A total of 6 patients ha
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SOURCE Amsterdam Molecular Therapeutics B.V
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