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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

Posted on: Thursday, 8 January 2009, 08:00 CST

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 candidates 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). Currently there is no marketed treatment for DGF; when DGF is diagnosed the patient is supported with dialysis and other supportive care.

The investigational drug candidate QPI-1002 is a siRNA designed to temporarily inhibit the expression of the pro-apoptotic gene, p53. This siRNA is based on Quark's proprietary, patented therapeutic concept of temporarily inhibiting the expression of p53 to protect normal cells from acute injury. QPI-1002 is a chemically modified siRNA discovered by Quark with structure covered under licenses from Silence Therapeutics and from Alnylam Pharmaceuticals. QPI-1002 was the first systemically administered siRNA in a human clinical study.

About Quark Pharmaceuticals, Inc.

Quark Pharmaceuticals, Inc. is a development-stage pharmaceutical company engaged in discovering and developing novel RNAi-based therapeutics. Quark has a fully integrated drug development platform that spans therapeutic target identification to drug development. Quark's RNAi technology includes novel siRNA structures and chemistry providing Quark with freedom to operate in the siRNA intellectual property arena, as well as the ability for non-invasive delivery of siRNA to other target tissues including the eye, ear, lung, spinal cord and brain.

PF-4523655 (RTP801i-14), currently in Phase II clinical trials, is a synthetic, chemically modified siRNA designed to inhibit the expression of the gene RTP801 discovered by Quark through the gene discovery platform BiFAR. PF-4523655 is licensed to Pfizer. In addition, Quark's current clinical pipeline includes QPI-1002, the first systemically administered siRNA drug in human clinical trials, developed by Quark for the prevention of acute kidney injury (AKI) following major cardiac surgery and of delayed graft function in kidney transplantation. QPI-1007, which is a siRNA that utilizes a novel siRNA structure developed by Quark and is being evaluated in advanced IND-enabling preclinical studies as a neuroprotective agent for eye diseases.

In addition, Quark has a broad pipeline of siRNA drug candidates based on novel structures developed internally. The Company expects to utilize the structures to develop additional RNAi drug candidates.

Quark is headquartered in Fremont, California and operates research and development facilities in Boulder, Colorado and Ness-Ziona, Israel. Additional information is available at www.quarkpharma.com

Quark Pharmaceuticals, Inc. Juliana Friedmann +972 89 30 5111 jfriedman@quarkpharma.com The Ruth Group (investors / media) Sara Ephraim / Janine McCargo (646) 536-7004 / 7033 sephraim@theruthgroup.com jmccargo@theruthgroup.com

SOURCE Quark Pharmaceuticals, Inc.

Source: PR Newswire

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