FDA News

Rexahn Pharmaceuticals Receives FDA Approval to Initiate a Phase II Trial for Archexin in Patients with Renal Cell Carcinoma

(May 29, 2007)-- Rexahn Pharmaceuticals, a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for cancer, central nervous system disorders, sexual dysfunction and other unmet medical needs, today announced that it has received approval from the U.S. Food & Drug Administration (FDA) to initiate a Phase II clinical trial for its lead oncology compound, Archexin (formerly known as RX-0201), in patients with renal cell carcinoma (RCC). Enrollment is expected to begin in Q3 2007.

Commenting on the news, Chang Ahn, Ph.D., Chairman and Chief Executive Officer of Rexahn Pharmaceuticals, said, “We are very pleased to have received FDA approval to move this important compound into a Phase II trial for renal cell carcinoma patients, most of whom have limited treatment options. 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.”

The Phase II trial, a non-blind, multi-center study, is designed to assess the efficacy of Archexin in patients with advanced RCC who have failed previous treatment or are unwilling or unable to be treated with standard systematic line therapy.

Share or bookmarklet this web page at: