Thursday, May 14, 2015 12:13:30 PM
"Dr. Traber added, "We are preparing to begin patient screening for our Phase 2 program in the coming weeks, which consists of a study in patients with NASH cirrhosis and a study in NASH patients with advanced fibrosis, but not cirrhosis. It should be noted as we embark on the next steps of our development strategy that Galectin has significantly invested in the chemical and pharmaceutical development of our compound, has implemented analytical methods to meet FDA requirements and is continually generating the necessary data to adequately characterize our drug compound. When a new chemical entity is chosen and defined as a potential drug candidate, the drug must be fully characterized. This drug characterization is necessary to understand the behavior of the drug, in solid state (drug substance) as well as in solution (drug product). Our working relationships with academic institutions and commercial analytical organizations with expertise in carbohydrate chemistry and analytical characterization of complex carbohydrate molecules helps to assure that our products are adequately characterized using the latest available technologies."
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