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Arete Therapeutics Initiates Phase 1 Clinical Trial For AR9281 as a First-in-Class Antihypertensive Agent
Date:11/1/2007

HAYWARD, Calif., Nov. 1 /PRNewswire/ -- Arete Therapeutics Inc. today announced the initiation of a phase 1 clinical trial for its lead compound, AR9281, for the treatment of hypertension. AR9281 is a "first-in-class," orally-active inhibitor of soluble epoxide hydrolase (s-EH), a novel target for the treatment of hypertension. The trial will enroll up to 32 healthy adult volunteers and will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics for single ascending doses of AR9281.

"AR9281 inhibits s-EH, an enzyme that plays a key role in the cytochrome P450 pathway of arachidonic acid metabolism, and offers a unique mechanism of action as an antihypertensive agent," said Dinesh V. Patel, Ph.D., president and chief executive officer of Arete Therapeutics Inc. "We believe this first-in-class compound has great potential to be a unique 'antihypertensive-plus' drug that not only lowers blood pressure but also offers end organ protection of the heart and kidney, and protection against vascular inflammation."

"The preclinical safety and efficacy profile of AR9281 is very encouraging and provided a solid basis for the initiation of the clinical development phase of this new compound class," commented Randall Whitcomb, M.D., chief medical officer of Arete Therapeutics Inc. "We look forward to reporting results from the initial phase 1 clinical trial in 2008."

Arete Therapeutics' phase 1 single ascending dose, placebo-controlled clinical trial in healthy volunteers will obtain initial safety and tolerance information as well as detailed blood pressure measurements. Levels of s-EH specific biomarkers will be analyzed together with typical inflammatory markers as part of the pharmacodynamic assessment. Following successful completion of the single dose study, Arete plans to initiate a multiple dose phase 1 study, a food effect study, and studies in special populations.

About AR9281

AR9281 is a novel small molecule inhibi
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SOURCE Arete Therapeutics Inc.
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