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Quark to initiate Phase 1 trial of AKIi-5 as the first human clinical study
involving the systemic delivery of siRNA
FREMONT, Calif., Aug. 2 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing novel RNA interference-based therapeutics, announced today the presentation of positive results from preclinical efficacy studies for its proprietary systemically-administered, siRNA compound, AKIi-5, in acute renal failure (ARF).
In the study, rats treated with a single bolus injection of rat AKIi-5, Quark's proprietary siRNA compound targeting the p53 gene, were significantly protected from ischemia/reperfusion-induced acute kidney injury. The compound was most efficacious when administered within a well-determined time window of 2-4 hours post injury. The study also proved that AKIi-5 has a favorable drug disposition (PK) profile, with short local exposure predominantly to the kidney-exhibiting rapid clearance of the drug post-administration. Quark's preclinical studies to date also indicate that AKIi-5 has a favorable safety profile, with a therapeutic index (toxic dose/effective dose) in rats greater than 250.
Elena Feinstein, M.D., Ph.D., the Company's Chief Scientific Officer, presented the results of the preclinical efficacy studies in a poster session at the Beyond Genome 2007 conference in San Francisco, CA. Quark's poster presentation was based on unpublished data. The studies were performed in collaboration with Bruce A. Molitoris, M.D., Director of the Division of Nephrology and Professor of Medicine at Indiana University School of Medicine, and lead academic investigator in the Quark program.
Daniel Zurr, CEO of Quark, commented, "Our pharmacokinetic,
distribution, and toxicity studies indicate that siRNA-mediated, temporary
inhibition of p53 by our systemically administered drug, AKIi-5, is a safe
and efficient way to treat and prevent acute
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SOURCE Quark Pharmaceuticals, Inc.![]() Copyright©2007 PR Newswire. |