Ardea Biosciences' Lead MEK Inhibitor, RDEA119, To Enter Human Clinical Trials In Advanced Cancer Patients

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 02 Oct 2007 - 0:00 PDT

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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, 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 Healthcare.

About RDEA119 and Ardea's MEK Inhibitor Program

Ardea Biosciences has a broad-based R&D program focused on the design and development of small-molecule inhibitors of mitogen-activated ERK kinase, or MEK, for the treatment of cancer and inflammatory diseases. Since defects in the RAS/RAF/MEK/ERK signaling pathway are closely associated with the development of human tumors, such as melanoma, colon, lung and thyroid cancers, inhibiting MEK signaling has promise in the treatment of many types of cancer. MEK inhibitors may also play an important role in the potential treatment of inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease, due to their ability to down-regulate inflammatory cytokines such as TNFalpha.

RDEA119, Ardea's lead compound from this program, is a potent, non-ATP competitive, highly selective inhibitor of MEK. Ardea plans to initiate a Phase 1 clinical trial evaluating RDEA119 in advanced cancer patients in the second half of 2007. Preclinical data suggest that RDEA119 may have favorable pharmaceutical properties, including the potential for convenient oral dosing and limited penetration into the brain, which, in turn, may result in a reduced risk of CNS side effects. Beyond RDEA119, the Company is evaluating a broad range of MEK inhibitors from several distinct chemical classes and plans to bring forward one of these compounds into a first-in-human study in the fourth quarter of this year.

About Ardea Biosciences, Inc.

Ardea Biosciences is focused on the discovery and development of small molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases. The Company plans to initiate clinical studies on four compounds this year. These include RDEA806, the Company's lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV, which recently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases, scheduled to enter Phase 1 clinical trials in the second half of 2007, and a follow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled to enter first-in-human studies in the fourth quarter of 2007.

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Ardea's goals, including its goal of initiating a Phase 1 study of RDEA119 in patients with advanced cancer and initiating clinical studies on three additional compounds this year, the expected properties and benefits of its compounds and the results of clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcomes of preclinical and clinical trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical tests, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in Ardea's most recently filed SEC documents, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Ardea undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Ardea Biosciences, Inc.
http://www.ardeabiosciences.com