Ardea Biosciences Initiates Phase 1/2 Study Of RDEA119, Its Lead MEK Inhibitor, In Combination With Nexavar® In Patients With Advanced Cancer

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 19 Oct 2008 - 0:00 PDT

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Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that it has initiated a Phase 1/2 study of RDEA119, its lead mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer, in combination with Nexavar, which is currently approved for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

Preclinical in-vitro and in-vivo studies of RDEA119 have demonstrated synergistic activity across multiple tumor types when RDEA119 is used in combination with other anti-cancer agents, including sorafenib. This Phase 1/2 study in patients with advanced cancer will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of RDEA119 in combination with Nexavar.

"The significant synergistic activity seen in preclinical studies of RDEA119 in combination with sorafenib makes this a promising new treatment for cancer patients," commented Dr. Peter J. O'Dwyer, Director of the Abramson Cancer Center, Hospital of the University of Pennsylvania, and the lead investigator of the Phase 1/2 study.

"We are very pleased with the progress of RDEA119, and look forward to assessing its safety, tolerability and efficacy in combination with Nexavar," commented Barry D. Quart, PharmD, Ardea's president and chief executive officer. "RDEA119 represents an exciting, new opportunity in cancer treatment. The synergistic activity that we have seen in preclinical studies of RDEA119 in combination with a broad range of anti-cancer agents suggests that RDEA119 has the potential to enhance the current standard-of-care across multiple cancer indications."

About RDEA119

RDEA119, a non-ATP competitive, highly-selective MEK inhibitor for the treatment of inflammatory diseases and cancer, is the Company's lead compound from its MEK inhibitor research and development program. RDEA119 has shown potential as a potent inhibitor of MEK, which is believed to play an important role in inflammation, as well as cancer cell proliferation, apoptosis and metastasis. Preclinical and clinical results suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and limited retention in the brain, which, in turn, may result in a reduced risk of central nervous system (CNS) side effects.

About Nexavar

Nexavar, a small-molecule drug, is being developed and marketed by Onyx Pharmaceuticals, Inc., in collaboration with Bayer HealthCare Pharmaceuticals, Inc. Nexavar is currently approved for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

About Ardea Biosciences, Inc.

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, gout, cancer and inflammatory diseases. We have five product candidates in clinical trials and others in preclinical development and discovery. Our most advanced product candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of gout, is being evaluated in a Phase 1 clinical trial and is believed to be an inhibitor of the URAT1 transporter in the kidney, which is responsible for regulation of uric acid levels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1/2 combination study with Nexavar and a Phase 1 study, both in advanced cancer patients, and have completed a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it for clinical development. www.ardeabio.com

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 goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the results of 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, and costs associated with our drug discovery and development programs and business development activities. 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.

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