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-- Completion of Phase 1 single-ascending-dose, multiple-ascending-dose,
food-effect, and drug-interaction clinical studies of RDEA806, our lead
non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV, in
August of 2007;
-- Presentation of four posters describing the favorable results of
preclinical and Phase 1 clinical trials with RDEA806 during the 47th
Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC);
-- Completion, submission and FDA approval of our investigational new drug
application (IND) for our lead mitogen-activated ERK kinase (MEK)
inhibitor, RDEA119, allowing us to proceed to Phase 1 clinical trials
in advanced cancer patients; and
-- Presentation of RDEA119 preclinical data, showing favorable properties,
including oral dosing, excellent selectivity and low central nervous
system (CNS) penetration, at the American Association of Cancer
Research (AACR), National Cancer Institute (NCI) and European
Organization for Research and Treatment of Cancer (EORTC) International
Conference on Molecular Targets and Cancer Therapeutics.
"We are well positioned for continued progress and success with our development programs in viral diseases, cancer and inflammatory diseases and are working to achieve several milestones in the next few months," added Dr. Quart. These include:
-- Initiation of a Phase 2a proof-of-concept trial with our lead NNRTI,
RDEA806;
-- Assessing a next-generation NNRTI from our follow-on program in a
first-in-human micro-dosing study;
-- Initiation of a Phase 1 advanced cancer clinical study of our lead MEK
inhibitor, RDEA119;
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