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About RDEA119 and Ardea's MEK Inhibitor Program
Ardea Biosciences has a broad-based R&D program focused on the design anddevelopment of small-molecule inhibitors of mitogen-activated ERK kinase, orMEK, for the treatment of cancer and inflammatory diseases. Since defects inthe RAS/RAF/MEK/ERK signaling pathway are closely associated with thedevelopment of human tumors, such as melanoma, colon, lung and thyroidcancers, inhibiting MEK signaling has promise in the treatment of many typesof cancer. MEK inhibitors may also play an important role in the potentialtreatment of inflammatory diseases, such as rheumatoid arthritis andinflammatory bowel disease, due to their ability to down-regulate inflammatorycytokines such as TNF alpha.
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RDEA119, Ardea's lead compound from this program, is a potent, non-ATPcompetitive, highly selective inhibitor of MEK. Ardea plans to initiate aPhase 1 clinical trial evaluating RDEA119 in advanced cancer patients in thesecond half of 2007. Preclinical data suggest that RDEA119 may have favorablepharmaceutical properties, including the potential for convenient oral dosingand limited retention in the brain, which, in turn, may result in a reducedrisk of CNS side effects. Beyond RDEA119, the Company is evaluating a broadrange of MEK inhibitors from several distinct chemical classes and plans tobring forward one of these compounds into a first-in-human study in the fourthquarter of this year.
About Ardea Biosciences, Inc.
Ardea Biosciences is focused on the discovery and development ofsmall-molecule therapeutics for the treatment of viral diseases, cancer andinflammatory diseases. The Company plans to initiate clinical studies on fourcompounds this year. These include RDEA806, the Company's lead non-nucleosidereverse transcriptase inhibitor (NNRTI) for the treatment of HIV, whichrecently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERKkinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases,which has been cleared by the FDA to enter Phase 1 clinical trials, and afollow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled toenter first-in-human studies in the fourth quarter of 2007.
Statements contained in this press release regarding matters that are nothistorical facts are "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995. Because such statements aresubject to risks and uncertainties, actual results may differ materially fromthose expressed or implied by such forward-looking statements. Such statementsinclude, but are not limited to, statements regarding: Ardea's goals,including its goal of initiating a Phase 1 study of RDEA119 in patients withadvanced cancer and initiating clinical studies on three additional compoundsthis year, the expected properties and benefits of its compounds and theresults of clinical and other studies. Risks that contribute to the uncertainnature of the forward-looking statements include: risks related to theoutcomes of preclinical and clinical trials, risks related to regulatoryapprovals, delays in commencement of preclinical and
