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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

tes from discovery into the clinic."

Principal investigator Osama Gaber, M.D., F.A.C.S. Director, Transplant Center of Excellence at The Methodist Hospital, Houston, Texas said, "Our clinical team is excited to participate in clinical trials that evaluate new therapies for renal transplant patients. Patients that develop DGF following renal transplantation have inferior kidney graft survival compared to those who do not. There is a real unmet medical need for a drug product to prevent DGF."

Daniel Zurr, Chief Executive Officer, commented, "We are very pleased to announce initiation of human dosing of the systemically administered QPI-1002 in our Phase I/II trial in kidney transplant patients. Furthermore, our siRNA drug candidate, PF-4523655, has been advanced into two Phase II clinical trials -- one for diabetic macular edema and the other for age related macular degeneration -- by our licensee, Pfizer. In addition, we recently announced that our QPI-1007 drug candidate, utilizing a novel siRNA structure developed by Quark, is being evaluated in advanced IND-enabling preclinical studies as a neuroprotective agent for eye diseases. These significant developments confirm the robustness of Quark's clinical pipeline and the strength of its capabilities in the RNAi arena."

Delayed graft function (DGF) is one of the most common complications during the immediate postoperative period in renal transplantation and affects 25-40% of the deceased donor renal transplants in the United States. DGF in renal transplantation results most often from ischemia-reperfusion injury that occurs when the blood flow is re-established to the transplanted kidney initiating a chain of events that can lead to severe renal damage upon transplantation. Post-kidney transplant DGF is associated with longer hospital stays and higher rates of graft rejection, which in turn decreases the survival of the transplanted kidney (graft survival). Current
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SOURCE Quark Pharmaceuticals, Inc.
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