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The three year follow-up data for the eight patients from the first clinical trial show a statistically significant, tenfold decrease in the incidence of acute pancreatitis. From the second trial in fourteen patients one year data are available showing similar results. The data from both trials also confirm that the treatment is well-tolerated and safe.
AMT has developed Glybera as a treatment for patients with the genetic disorder lipoprotein lipase deficiency. LPLD is an orphan disease for which no treatment exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL protein in patients. This protein is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels. Excess chylomicrons result in recurrent and severe acute inflammation of the pancreas, called pancreatitis, the most debilitating complication of LPLD. In the second trial it was observed that the white colouring of blood vessels in het eyes of patients (lipemia retinalis) disappeared after administration of GlyberaTM showing that this gene therapy lowers the chylomicron levels in the blood. The disease can result in difficult-to-treat diabetes and is associated with significant morbidity and mortality.
About AmsterdamMolecular Therapeutics
AMT has a unique production platform that circumvents the obstacles that have hindered development of gene therapy technologies into drugs. Using adeno-associated viral vectors as the delivery vehicle of choice for therapeutic genes, the company has designed and validated a stable, scalable, commercially attractive and GMP-compliant AAV manufacturing platform. As such, AMT's proprietary platform holds tremendous promise for thousands of rare (orphan) diseases that are caused by one faulty gene. AMT currently has a product pipeline with nine products at different stages of development.
CONTACT: Rob Janssen, Director Corporate Communications & Investor Relations Tel: +31 (0)20 566 7509 Tel: +31 (0)65 470 8865 e-mail: r.janssen@amtbiopharma.com Andre Verwei, CFO Tel +31 (0)20 566 7394 e-mail: a.verwei@amtbiopharma.com WWW: http://www.amtbiopharma.com
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