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Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function
Date:1/8/2009

Kidney transplantation to be Quark's second indication with clinical-stage, systemically administered siRNA product candidate

FREMONT, Calif., Jan. 8 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing novel RNA interference (RNAi)-based therapeutics, today announced that it has initiated patient dosing in its Phase I/II clinical trial evaluating its systemically administered siRNA drug candidate QPI-1002 (previously referred to as DGFi) for prevention of Delayed Graft Function (DGF) in patients undergoing deceased donor kidney transplantation. DGF represents Quark's second indication being evaluated for the systemically administered dug candidate in human clinical trials. This trial follows two currently enrolling Phase I clinical trials in acute kidney injury (AKI).

The multi-center, two-part Phase I/II clinical trial in DGF is expected to enroll up to 204 adult kidney transplant recipients. The first part of the study is a dose-escalation design to evaluate the safety and tolerability of a single intravenous injection of QPI-1002 in renal transplant patients at high risk to develop DGF. The second part of the study will evaluate safety and potential clinical activity of a selected dose of QPI-1002 in the same patient population. Patients will be enrolled in clinical sites in the United States.

Shai Erlich, Ph.D., Chief Medical Officer of Quark, commented, "The initiation of patient dosing with QPI-1002 is an important milestone for Quark as well as being an innovative approach to offer therapeutic benefit to adult kidney transplant patients at high risk for developing DGF. The siRNA drug candidate is based on the proprietary concept of Quark and reflects Quark's success in developing products originating from conceptually novel internal developments. These accomplishments further validate Quark's ability to advance innovative product candida
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SOURCE Quark Pharmaceuticals, Inc.
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