Rexahn Pharmaceuticals, Inc. has 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 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," stated Dr. Chang Ahn, CEO of Rexahn Pharmaceuticals.
Dr. Ahn concluded, "We continue to make significant progress in advancing our industry-leading research and development pipeline, focused on compounds designed to address serious unmet clinical needs. With Archexin cleared to commence Phase II trials, we are one step closer to commercializing a novel, new cancer drug that spans the major classes of oncology therapeutics."
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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