Ardea Biosciences Initiates a Phase 1/2 Study of RDEA119, its Lead MEK Inhibitor, in Combination with Nexavar® (sorafenib) i...
October 16 2008 - 8:00AM
Business Wire
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. 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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