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www.fdanews.com/articles/101249-quark-announces-first-systemic-sirna-dosing

Quark Announces First Systemic siRNA Dosing

November 19, 2007

Quark Pharmaceuticals has started systemic dosing in humans of its proprietary product candidate AKIi-5, a siRNA compound for the treatment of acute renal failure (ARF).

The multicenter, double-blind, placebo-controlled, dose-escalation Phase I trial will assess the safety and pharmacokinetics of AKIi-5 administered intravenously as a single dose to patients undergoing major cardiac surgery, which is one cause of ARF.

Patients will be enrolled in the trial in a number of centers in the U.S., Europe and Israel. Quark said it expects to complete the trial in early 2008 and, depending on the results, hopes to initiate a dose-ranging Phase II clinical trial measuring AKIi-5 clinical activity.