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Quark Pharmaceuticals Receives FDA Approval of IND for Kidney Transplant siRNA Drug DGFi
Date:6/26/2008

Quark's second siRNA drug delivered systemically

FREMONT, Calif., June 25 /PRNewswire/ -- Quark Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its siRNA drug candidate, DGFi, in kidney transplantation. The Company expects its Phase I/II clinical study for prevention/treatment of Delayed Graft Function (DGF) in kidney transplant patients to begin in the second half of 2008.

DGFi is Quark's second product candidate to enter clinic trials that is systemically administered to patients. The first ever siRNA drug candidate to be delivered systemically in man was Quark's AKIi-5 which is in Phase I clinical trial for acute kidney injury.

The Phase I/II will be a multi center study in which the safety and tolerability of escalating doses of DGFi by a single IV injection in renal transplant patients with DGF. Up to 204 adult kidney transplant recipients will be enrolled in this 2-part study.

"We are pleased with the FDA acceptance of our DGFi IND application for prevention of delayed graft function, which is a very serious medical issue for kidney transplant patients," said Shai Erlich, Ph.D., Chief Development Officer of Quark. "This is an important milestone for us. It marks Quark's third clinical program and the second in which our siRNA drug is administered systemically to patients. This achievement provides further validation of Quark's RNAi based drug discovery approach."

About DGF and Kidney Transplant

Delayed Graft Function (DGF) in renal transplantation is a syndrome caused by ischemia and reperfusion injury. Ischemia reperfusion injury occurs frequently in kidneys that have been outside a living human body and damaged from lack of oxygen in the kidneys that have been blood deprived. In patients with DGF the transplanted kidney does not function properly and requires intervention by dialysis.


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SOURCE Quark Pharmaceuticals, Inc.
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