Quark's second siRNA drug delivered systemically FREMONT, Calif., June 25
FREMONT, Calif., June 25 /PRNewswire/ -- Quark Pharmaceuticals, Inc. today
announced that the U.S. Food and Drug Administration (FDA) has approved the
Company's Investigational New Drug (IND) application for its siRNA drug
candidate, DGFi, in kidney transplantation. The Company expects its Phase
I/II clinical study for prevention/treatment of Delayed Graft Function (DGF)
in kidney transplant patients to begin in the second half of 2008.
DGFi is Quark's second product candidate to enter clinic trials that is
systemically administered to patients. The first ever siRNA drug candidate to
be delivered systemically in man was Quark's AKIi-5 which is in Phase I
clinical trial for acute kidney injury.
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 2-part study.
"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," said Shai Erlich, Ph.D., Chief Development
Officer of Quark. "This is an important milestone for us. It marks Quark's
third clinical program and the second in which our siRNA drug is administered
systemically to patients. This achievement provides further validation of
Quark's RNAi based drug discovery approach."
About DGF and Kidney Transplant
Delayed Graft Function (DGF) in renal transplantation is a syndrome caused
by ischemia and reperfusion injury. Ischemia reperfusion injury occurs
frequently in kidneys that have been outside a living human body and damaged
from lack of oxygen in the kidneys that have been blood deprived. In patients
with DGF the transplanted kidney does not function properly and requires
intervention by dialysis.
Delayed graft function (DGF) is the most common complication during the
immediate postoperative period in renal transplantation and affects 25-40% of
the cadaveric renal transplants in the United States. In addition to donor,
recipient, transplant procedure and the choice of immunosuppression may
influence DGF development. Post kidney transplant DGF is associated with
increased of length of hospital stay, and higher rate of graft rejection,
resulting in decreased short and long-term survival. Currently when DGF is
diagnosed, the main strategy is to support the patient with dialysis and to
monitor for rejection with serial biopsies.
About DGFi
DGFi is an siRNA designed to temporarily inhibit the activity of the p53
gene that is based on Quark's proprietary, patented therapeutic of temporarily
and reversibly inhibiting the expression of the transcription factor human
p53, which is associated with DNA repair and apoptosis. The concept was first
published by Quark with the University of Chicago in a breakthrough paper in
Science magazine (Science. 1999 Sep 10; 285). Preclinical studies have shown
that p53-targeted siRNA can be effective in protecting kidneys from injury due
to cold ischemia or lack of oxygen during organ preservation and storage
between removal from the donor and implantation. DGFi is a chemically modified
siRNA with an AtuRNAi technology-based structure licensed from Silence
Therapeutics and for which Quark has also licensed certain intellectual
property from Alnylam.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc. is a development-stage pharmaceutical company
engaged in discovering and developing novel therapeutic RNAi drug candidates.
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 that the Company believes provide Quark
with freedom to operate in the siRNA intellectual property arena, as well as
the ability to deliver siRNA locally and systemically to organs including the
eye, ear, kidney, lung, spinal cord and bone marrow.
Quark's lead product, PF-4523655 (RTP801i-14), completing Phase I/IIa
clinical trials, is a synthetic, chemically modified, siRNA molecule to
temporarily inhibit the expression of Quark's proprietary target gene RTP801.
PF-4523655 is licensed to Pfizer on an exclusive worldwide basis. Quark
expects its partner, Pfizer, to continue to progress PF-4523655 through Phase
II clinical trials for the treatment of AMD and diabetic macular edema (DME).
In addition, Quark's current clinical pipeline includes AKIi-5, developed by
Quark for the prevention of acute kidney injury (AKI) following major cardiac
surgery, currently in Phase I/IIa clinical trials via systemic delivery. Based
on publicly available information, Quark believes this was the first siRNA
delivered systemically in a human clinical trial. The Company has licenses for
AtuRNAi(TM) technology from Silence Therapeutics and additional RNAi
intellectual property from Alnylam.
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
Contact:
Janine McCargo
+1-646-536-7033
jmccargo@theruthgroup.com
SOURCE Quark Pharmaceuticals, Inc.
