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Array BioPharma Reports New Clinical Data on Its Anti-Inflammatory,Drugs

BOULDER, Colo.--(BUSINESS WIRE)--Jun 20, 2007 - Array BioPharma Inc. (Nasdaq: ARRY) announced new Phase 1 clinical data on its MEK inhibitor, ARRY-162, and its p38 inhibitor, ARRY-797. These results were presented at the Annual European Congress of Rheumatology (EULAR) in Barcelona, Spain, and at the International Association of Inflammation Societies' (IAIS) 8th World Congress on Inflammation in Copenhagen, Denmark.

ARRY-162 / MEK Inhibitor Phase 1 Results

Array presented preliminary information on its MEK inhibitor, ARRY-162, from both a single ascending dose (SAD) and a multiple ascending dose (MAD) Phase 1 clinical trial. In the SAD study, the drug was given orally at doses of 5 to 80 mg. In blood samples taken from these volunteers and stimulated ex vivo, ARRY-162 was shown to inhibit the production of IL-1beta, TNF-alpha, IL-6 and phosphoERK (pERK). IL-1beta was inhibited most potently and to the greatest extent, whereas pERK, a measure of proliferation, was the least inhibited. In the MAD study, volunteers were given doses ranging from 5 to 60 mg daily, for 14 days. Steady state drug exposure was proportional to dose and did not change with repeated dosing. In volunteers receiving daily doses of 40 mg of ARRY-162, inhibition of 50 to 90 percent of IL-1beta, TNF-alpha, and IL-6 was observed when measured over a 24-hour period. There were no significant changes in clinical laboratory values and no serious adverse events observed in either the SAD or MAD studies. Dose escalation studies with ARRY-162, in combination with methotrexate, are ongoing in rheumatoid arthritis patients with stable disease. Phase 2 studies are planned to start by the end of 2007.

ARRY-797 / p38 Inhibitor Phase 1 Results

In a SAD study in healthy volunteers, ARRY-797 was shown to have linear increases in exposure with increasing oral dose; the dose range studied was from 25 to 400 mg. The drug was well-tolerated
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