Ardea Biosciences Presents Preclinical Data on its Lead MEK Inhibitor, RDEA119, Demonstrating Synergy with Other Anti-Cancer ...
October 24 2008 - 8:07AM
Business Wire
Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that it
presented preclinical data on its lead mitogen-activated ERK kinase
(MEK) inhibitor at the 20th 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 Geneva, Switzerland.
In preclinical studies, RDEA119 has demonstrated synergistic
activity when used in combination with multiple anti-cancer agents
in a wide range of tumor cell lines. Additionally, RDEA119 has
demonstrated the ability to produce significant tumor cell death
when administered in combination with sorafenib (Nexavar�; Onyx
Pharmaceuticals, Bayer HealthCare) in cancer cells that had
developed resistance to sorafenib. Doses being evaluated in an
ongoing Phase 1 study of RDEA119 as a single agent in patients with
advanced cancer have achieved systemic exposure consistent with
active doses in animal models of human tumors, without drug-related
toxicity. A Phase 1/2 study in combination with Nexavar in patients
with advanced cancer has been recently initiated. �The preclinical
data presented today formed the rationale for our Phase 1/2 study
of RDEA119 in combination with Nexavar,� commented Barry D. Quart,
PharmD, Ardea�s president and chief executive officer. �RDEA119�s
potential to enhance the activity of current cancer therapies and
its broad activity against both K-ras and B-raf mutations makes
RDEA119 a very promising product candidate to improve the current
standard-of-care across multiple cancer indications. We are pleased
with the progress that we have made with RDEA119 thus far and look
forward to working with a partner in the future to bring this
important potential therapy to patients.� The poster is available
on the Company website (http://www.ardeabio.com) under the title,
�RDEA119: A Potent and Highly Selective MEK Inhibitor for the
Treatment of Cancer.� 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 hyperuricemia and 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 study in
combination with sorafenib (Nexavar�; Onyx Pharmaceuticals, Bayer
HealthCare) and as a single agent in 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 plans and goals, the expected properties and benefits of
RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 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. 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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