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news.Manhattan Pharmaceuticals has said that the first patient has received the initial dose in the Phase II study of its lead topical product candidate for psoriasis.
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This study is designed to evaluate safety and preliminary efficacy of topical psoriasis drug, PTH (1-34). Approximately 54 subjects will be enrolled and randomized to receive one of two dose levels of topical PTH (1-34), or vehicle, for an eight week treatment period. In this study, the vehicle is the topical formulation without the active ingredient, PTH (1-34).
In September 2007, the FDA accepted Manhattan Pharmaceuticals’ corporate investigational new drug (IND) application for the company’s new formulation of topical PTH (1-34). In addition, the company has filed new patent applications in the US with respect to the new proprietary formulation.