Results to be Presented at the World Transplant Conference on July 28, 2014
FREMONT, CA, USA I July 1, 2014 I Quark Pharmaceuticals, Inc. today reported completion of a randomized, placebo-controlled multicenter Phase II trial of QPI-1002 for the prophylaxis of delayed graft function (DGF) in ESRD dialysis-dependent patients undergoing deceased donor kidney transplantation. The results of the trial will be presented at the 2014 World Transplant Conference in San Francisco, as an oral presentation in the late-breaking session on Monday, July 28, 2014. Novartis has an exclusive worldwide license option for the development and commercialization QPI-1002.
The study was a placebo-controlled, randomized, prospective, double-blind, multicenter, phase II study of the safety and clinical activity of Quark’s siRNA compound QPI-1002, which is the first siRNA compound to be used systemically in human clinical trials. The Phase II trial enrolled 332 patients randomized to receive deceased donor organs, primarily from extended criteria donors (ECD). The study involved 52 centers in the United States, Canada, France, Germany and Spain. The study subjects were randomized 1:1 to receive 10 mg/kg single bolus IV dose of QPI-1002 or placebo at 30 minutes following reperfusion. The primary endpoint was the incidence of DGF, assessed as the incidence of dialysis as defined per protocol (the necessity for dialysis during the first 7 days following the transplantation, with the exclusion of dialysis given due to specific DGF-unrelated reasons that were prospectively defined in the protocol). The secondary end points included a set of parameters measuring other definitions of DGF, dialysis occurrence, duration and severity per patient immediately after transplantation and during the follow up period (up to 6 month post transplant) as well as kidney function parameters.
“We are pleased to have completed this study as planned, and we look forward to sharing the exciting results at the upcoming WTC meeting,” said Dr. Daniel Zurr, CEO of Quark. “Delayed graft function adversely affects outcomes following deceased donor kidney transplantation and is a significant problem for which there is currently no approved treatment. We hope that QPI-1002 could improve outcomes and encourage greater utilization of deceased donor kidneys allowing the use of additional kidneys and shortening the transplant waiting list.”
About QPI-1002
QPI-1002 is an investigational drug designed to temporarily inhibit the expression of the pro-apoptotic gene, p53, to protect normal cells from acute injury. Preclinical studies have shown that p53-targeted siRNAs can protect kidneys from ischemia/reperfusion injury that can occur following transplantation. For the prevention of DGF in kidney transplant patients QPI-1002 has been granted Orphan Drug designation in the USA and Europe.
About Delayed Graft Function (DGF) in Kidney Transplantation
DGF is one of the most common complications during the immediate postoperative period in renal transplantation, affecting 25-40% of deceased donor renal transplant recipients. DGF most often results from ischemia/reperfusion injury, when blood flow is re-established to the kidney following transplantation and initiates a chain of events that can lead to severe renal damage. DGF is associated with longer hospital stays and higher rates of graft rejection, which decreases transplanted kidney survival (graft survival). There is no currently marketed drug therapy for the prevention or treatment of DGF.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc., the world leader in novel therapeutic RNAi discovery and development, has the largest clinical-stage siRNA pipeline in the industry. The Company’s fully integrated drug development platform spans therapeutic target identification to drug development. Quark’s approach to delivery allows targeting of tissues and organs including the eye, kidney, ear, lung, skin, spinal cord and brain. Quark has three siRNA product candidates in clinical development in five different disease indications of which four are in Phase II. Quark’s Joint venture in China, Kunshan Ribo-Quark Pharmaceutical Inc, and its strategic partner in India, Biocon Limited, are part of Quark’s world wide clinical studies network.
Quark is headquartered in Fremont, California and operates research and development facilities in Boulder, Colorado and Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com.
SOURCE: Quark Pharmaceuticals
Post Views: 274
Results to be Presented at the World Transplant Conference on July 28, 2014
FREMONT, CA, USA I July 1, 2014 I Quark Pharmaceuticals, Inc. today reported completion of a randomized, placebo-controlled multicenter Phase II trial of QPI-1002 for the prophylaxis of delayed graft function (DGF) in ESRD dialysis-dependent patients undergoing deceased donor kidney transplantation. The results of the trial will be presented at the 2014 World Transplant Conference in San Francisco, as an oral presentation in the late-breaking session on Monday, July 28, 2014. Novartis has an exclusive worldwide license option for the development and commercialization QPI-1002.
The study was a placebo-controlled, randomized, prospective, double-blind, multicenter, phase II study of the safety and clinical activity of Quark’s siRNA compound QPI-1002, which is the first siRNA compound to be used systemically in human clinical trials. The Phase II trial enrolled 332 patients randomized to receive deceased donor organs, primarily from extended criteria donors (ECD). The study involved 52 centers in the United States, Canada, France, Germany and Spain. The study subjects were randomized 1:1 to receive 10 mg/kg single bolus IV dose of QPI-1002 or placebo at 30 minutes following reperfusion. The primary endpoint was the incidence of DGF, assessed as the incidence of dialysis as defined per protocol (the necessity for dialysis during the first 7 days following the transplantation, with the exclusion of dialysis given due to specific DGF-unrelated reasons that were prospectively defined in the protocol). The secondary end points included a set of parameters measuring other definitions of DGF, dialysis occurrence, duration and severity per patient immediately after transplantation and during the follow up period (up to 6 month post transplant) as well as kidney function parameters.
“We are pleased to have completed this study as planned, and we look forward to sharing the exciting results at the upcoming WTC meeting,” said Dr. Daniel Zurr, CEO of Quark. “Delayed graft function adversely affects outcomes following deceased donor kidney transplantation and is a significant problem for which there is currently no approved treatment. We hope that QPI-1002 could improve outcomes and encourage greater utilization of deceased donor kidneys allowing the use of additional kidneys and shortening the transplant waiting list.”
About QPI-1002
QPI-1002 is an investigational drug designed to temporarily inhibit the expression of the pro-apoptotic gene, p53, to protect normal cells from acute injury. Preclinical studies have shown that p53-targeted siRNAs can protect kidneys from ischemia/reperfusion injury that can occur following transplantation. For the prevention of DGF in kidney transplant patients QPI-1002 has been granted Orphan Drug designation in the USA and Europe.
About Delayed Graft Function (DGF) in Kidney Transplantation
DGF is one of the most common complications during the immediate postoperative period in renal transplantation, affecting 25-40% of deceased donor renal transplant recipients. DGF most often results from ischemia/reperfusion injury, when blood flow is re-established to the kidney following transplantation and initiates a chain of events that can lead to severe renal damage. DGF is associated with longer hospital stays and higher rates of graft rejection, which decreases transplanted kidney survival (graft survival). There is no currently marketed drug therapy for the prevention or treatment of DGF.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc., the world leader in novel therapeutic RNAi discovery and development, has the largest clinical-stage siRNA pipeline in the industry. The Company’s fully integrated drug development platform spans therapeutic target identification to drug development. Quark’s approach to delivery allows targeting of tissues and organs including the eye, kidney, ear, lung, skin, spinal cord and brain. Quark has three siRNA product candidates in clinical development in five different disease indications of which four are in Phase II. Quark’s Joint venture in China, Kunshan Ribo-Quark Pharmaceutical Inc, and its strategic partner in India, Biocon Limited, are part of Quark’s world wide clinical studies network.
Quark is headquartered in Fremont, California and operates research and development facilities in Boulder, Colorado and Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com.
SOURCE: Quark Pharmaceuticals
Post Views: 274
