Quark Announces Completion of Phase II Trial Evaluating QPI-1002 for
Prevention of Delayed Graft Function in Kidney Transplant Patients
Results to be Presented at the World Transplant Conference on July 28, 2014
FREMONT, Calif., July 1, 2014 (GLOBE NEWSWIRE) -- 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 theUnited 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
"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
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
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.
CONTACT: Quark Pharmaceuticals, Inc.
+972 89 30 5111
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