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Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
Date:11/19/2007

ay be even more noteworthy as it represents the first documented systemic dosing of siRNA in humans. While the science of RNAi has been well-established, a key step in the acceptance of the technology as a promising therapeutic is the ability to deliver RNAi-based compounds systemically. We look forward to leading this important advance for the industry and, at the same time, continuing the development of this and other siRNA products in our pipeline."

Quark was granted an IND by the Food and Drug Administration (FDA) for AKIi-5 for the prevention of Acute Renal Failure in high-risk patients undergoing major cardiovascular surgery. AKIi-5 is a synthetic, chemically modified siRNA molecule discovered and patented by Quark that has an AtuRNAi technology-based structure licensed from Silence Therapeutics. Quark has also licensed certain intellectual property from Alnylam.

Quark has conducted pre-clinical studies of AKIi-5 for the prevention of acute renal failure in rats and monkeys. Rats treated with a single bolus injection of AKIi-5 were significantly protected from ischemia/reperfusion- induced acute kidney injury. In the rat studies, AKIi-5 effectively prevented the development of acute renal failure. Quark's pharmacokinetic, distribution, and toxicity studies in rats and monkeys indicate that AKIi-5 appears to have a favorable safety profile and has a relatively short residence time in the kidney.

About AKIi-5

AKIi-5 is a synthetic, chemically modified siRNA molecule designed to temporarily inhibit the expression of p53, a gene which plays a significant role in ARF by inducing tubular cell death (apoptosis) in response to injury. AKIi-5 is based on Quark's proprietary, patented concept of temporary and reversible inhibition, for therapeutic purposes, of the expression of the transcription factor human p53, which is associated with DNA repair and apoptosis. The concept was first published by Quark with the University of Illinois in a breakt
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SOURCE Quark Pharmaceuticals, Inc.
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