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Ardea Announces Data on MEK Inhibitor BAY 86-9766 (RDEA119) to be Presented at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

SAN DIEGO, Nov. 11, 2010 /PRNewswire/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced that data from preclinical and clinical trials of BAY 86-9766 (formerly known as RDEA119) will be presented at the 22nd European Organisation for Research and Treatment of Cancer (EORTC) – National Cancer Institute (NCI) – American Association for Cancer Research (AACR) symposium on "Molecular Targets and Cancer Therapeutics" in Berlin, Germany.  BAY 86-9766 is a mitogen-activated ERK kinase (MEK) inhibitor licensed to and being developed by Bayer HealthCare AG.

The results of a multi-center, Phase 1, monotherapy, dose-escalation study of BAY 86-9766 in advanced cancer patients will be presented by Colin Weekes, MD, PhD, Assistant Professor, Division of Medical Oncology at the University of Colorado School of Medicine. The principal investigators for this study included Dr. Weekes, Daniel D. Von Hoff, MD, Professor of Medicine at the University of Arizona School of Medicine and Executive Vice President of the Translational Genomics Research Institute (TGen), and Alex Adjei, MD, PhD, Professor and Chair, Department of Medicine at the Roswell Park Cancer Institute. In addition, data from preclinical studies of BAY 86-9766, demonstrating its potential for administration in combination with other anti-cancer agents will be presented by Bayer.

"Based on the good tolerability and impressive number of patients who achieved stable disease in this Phase 1 monotherapy trial in refractory patients with advanced solid tumors, we believe BAY 86-9766 has the potential to be a clinically important drug in the treatment of patients across multiple tumor types," said Dr. Adjei. "These monotherapy results support our ongoing Phase 1/2 study of BAY 86-9766 in combination with sorafenib at the maximum tolerated dose defined in this trial and the continued research by Bayer Healthcare on this important new targeted therapy."

Poster presentation details are as follows:Poster Title:

A Multi-Center Phase 1, Dose-Escalation Trial to Determine the Safety and Pharmacokinetics/Pharmacodynamics of BAY 86-9766 (RDEA119), a MEK Inhibitor, in Advanced Cancer PatientsAbstract:


Thursday, November 18, 2010 from 12:00 PM – 2:40 PM CET(Submitted by Ardea Biosciences, Inc.)Poster Title:

Combination of PI3K Inhibitor BAY 80-6946 with Allosteric MEK Inhibitor BAY 86-9766 (RDEA119) and with Erlotinib for the Treatment of Non-Small Cell Lung CancerAbstract:


Wednesday, November 17, 2010 from 12:00 PM – 2:40 PM CET(Submitted by Bayer HealthCare AG)Poster Title:

Combination of PI3K Inhibitor BAY 80-6946 with Allosteric MEK Inhibitor BAY 86-9766 (RDEA119), a Promising Approach for the Treatment of Colorectal CancersAbstract:


Wednesday, November 17, 2010 from 12:00 PM – 2:40 PM CET(Submitted by Bayer HealthCare AG)Poster Title:

Allosteric MEK Inhibitor BAY 86-9766 (RDEA119) Shows Anti-Tumor Efficacy in Mono- and Combination Therapy in Models of Hepatocellular Carcinoma and Pancreatic CancerAbstract:


Wednesday, November 17, 2010 from 12:00 PM – 2:40 PM CET(Submitted by Bayer HealthCare AG)About Ardea Biosciences, Inc.Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.  RDEA594, our lead product candidate for the chronic management of hyperuricemia and gout, is a once-daily, oral inhibitor of the URAT1 transporter inhibitor in Phase 2 clinical development.  Our next-generation URAT1 inhibitor program is currently in preclinical development.  BAY 86-9766, formerly known as RDEA119, is a potent and specific inhibitor of mitogen-activated ERK kinase (MEK) for the treatment of cancer being developed under a global license agreement with Bayer HealthCare AG.  BAY 86-9766 has been evaluated in advanced cancer patients with different tumor types as a single agent in a Phase 1 study and is currently being evaluated in combination with sorafenib (Nexavar®; Bayer HealthCare, Onyx Pharmaceuticals) in a Phase 1/2 study.  Our two product candidates for the treatment of HIV, RDEA806 and RDEA427, are non-nucleoside reverse transcriptase inhibitors (NNRTIs), which have successfully completed a Phase 2a study in HIV patients and a human micro-dose pharmacokinetic study in healthy volunteers, respectively.

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 our plans and goals, the expected properties and benefits of RDEA594, BAY 86-9766 (RDEA119), RDEA806, RDEA427 and our other compounds and the timing and results of our preclinical, clinical and other studies.  Risks that contribute to the uncertain nature of the forward-looking statements include risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, costs associated with our drug discovery and development programs, and risks related to the outcome of our business development activities, including collaboration or license agreements.  These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our 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.  We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



SOURCE Ardea Biosciences, Inc.
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