Rexahn Pharmaceuticals Initiates Phase II Pancreatic Cancer Clinical Trial

26-Mar-2009 - USA

Rexahn Pharmaceuticals, Inc. announced that it has received FDA approval to begin Phase II trials for Archexin, the Company’s leading cancer compound, for the treatment of pancreatic cancer. This will be a multi-center trial with preliminary data in humans expected in 2010.

Archexin is a first-in-class, potent Akt protein kinase inhibitor with potential utility to inhibit cancer cell survival and proliferation, angiogenesis and drug resistance. Based upon Phase I clinical trial data, Archexin has an excellent human safety profile, with fatigue being the only side effect. Archexin has FDA Orphan drug designation for five different cancer types, including renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian cancers.

The Archexin Phase IIa trial is a single-arm, open-label study conducted at global sites in the U.S. 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.

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