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news.Thallion Pharmaceuticals and the FDA have agreed on a regulatory framework to include US sites in the Shigamabs Phase II/III program that is planned to begin in the first half of 2008, for the treatment of Shigatoxin-mediated E. coli infections.
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Thallion has agreed to conduct certain additional animal studies concurrent with the US clinical study, the results of which will be submitted to the FDA in advance of filing for marketing approval.
Lloyd Segal, CEO of Thallion, said: “With the positive feedback of the key regulators in the jurisdictions where we intend to run the Phase II/III trial, specifically South America, Europe and the US, we now believe that we have a clear regulatory pathway by which to execute our global Shigamabs clinical development strategy.”