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news.Quark Pharmaceuticals has announced that the FDA has approved the company's investigational new drug application for its siRNA drug candidate, DGFi, in kidney transplantation.
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The company expects its Phase I/II clinical study for prevention or treatment of delayed graft function (DGF) in kidney transplant patients to begin in the second half of 2008.
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 two-part study.
Shai Erlich, chief development officer of Quark, said: “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.”