US biopharmaceutical company Rexahn Pharmaceuticals has received FDA approval to initiate a phase II trial for its lead oncology compound Archexin in patients with renal cell carcinoma, the most common form of kidney cancer.
Subscribe to our email newsletter
Rexahn, which specializes in discovering, developing and commercializing treatments for cancer among other diseases, said that enrollment for the phase II trial of Archexin, a first-in-class signal inhibitor, is expected to begin in Q3 2007.
The phase II trial will be a non-blind, multi-center study. According to Rexahn, the trial is designed to assess the efficacy of Archexin in patients with advanced renal cell carcinoma (RCC) who have failed previous treatment or are unwilling or unable to be treated with standard systematic line therapy.
Chang Ahn, chairman and CEO of Rexahn, commented: “Archexin is designed to disrupt the signals responsible for cancer progression, and as such, may someday offer patients a more targeted, less toxic therapeutic approach to cancer treatment. We look forward to moving this compound ahead in its clinical development.”
According to Rexahn, in both preclinical and phase I clinical trials, Archexin demonstrated effectiveness at inhibiting the proliferation of various cancer cells at nanomolar concentrations and regulating the growth of tumors.
Archexin was granted an “orphan drug designation” for kidney, stomach, ovarian, pancreas and brain cancers by the FDA in December 2004.