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news.Rexahn Pharmaceuticals, a biopharmaceutical company, has received the FDA approval to begin Phase II trials for Archexin, the company's cancer compound, for the treatment of pancreatic cancer.
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The Archexin Phase IIa trial is a single-arm, open-label study conducted at global sites in the US and India. Archexin will be administered in combination with gemcitabine in patients with advanced pancreatic cancer to assess safety and preliminary efficacy, maximum tolerated dose, and overall survival. This will be a multi-center trial with preliminary data in humans expected in 2010.
Chang Ahn, CEO of Rexahn, said: “The initiation of the Archexin Phase II trial represents a significant clinical development milestone for Archexin and a major achievement for Rexahn. Archexin has the potential to treat multiple life-threatening cancers, and has demonstrated a superior safety profile when compared to the current standard of care.”