Ardea Biosciences' Lead MEK Inhibitor, RDEA119, to Enter Human Clinical Trials in Advanced Cance...( - Multi-Center Phase...),Health

- Multi-Center Phase 1 Trial to Commence -

CARLSBAD, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Pink Sheets: ARDC), a company focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) granted safe-to-proceed status to the Investigational New Drug (IND) application for RDEA119, enabling initiation of a Phase 1 clinical trial in advanced cancer patients. RDEA119 is a highly potent and selective inhibitor of mitogen-activated ERK kinase (MEK), a key component of the RAS/RAF/MEK/ERK pathway that is commonly defective in human tumors.

Ardea Biosciences plans to conduct the Phase 1 clinical trial at several academic medical centers in the United States. The open-label, dose-escalation trial is designed to evaluate the safety, tolerability and pharmacokinetics of RDEA119 following oral administration in patients with advanced cancer. In addition, the trial is designed to examine biomarkers of therapeutic activity in these patients.

"Cancer is the second most common cause of death in the United States, and, although progress is being made, there is still a significant unmet medical need. The FDA's clearance for us to proceed with our Phase 1 study is a key step forward in the development path for RDEA119, as well as our MEK inhibitor program in general," said Barry Quart, PharmD, President and CEO.

"In clinical trials, MEK inhibitors have been shown to have activity in patients with certain kinds of cancers. With its selectivity, potency and limited penetration into the brain, RDEA119 appears to have a very favorable profile. We are very excited to be selected to participate in the Phase 1 program for this interesting molecule," said Dan Von Hoff, MD, Physician in Chief, Translational Genomics Research Institute and Chief Scientific Officer, Scottsdale Healthc
'/>"/>