MEDIA RELEASE PR37199
Quark Reports Progress of siRNA Clinical Programs; 300 Patients Dosed With Quark
Pharmaceuticals' siRNA Drugs In Multiple Fully Enrolled Clinical Trials
FREMONT, Calif., Nov. 20 /PRNewswire-AsiaNet/ --
With IND Now Open, Fifth Clinical Study, in Ocular Neuroprotection, Set to
Begin in 1Q10
Quark Pharmaceuticals, Inc., the leader in siRNA therapeutics in clinicals,
announced today that four of its siRNA R&D platform based programs have met clinical
development milestones; patient enrollment was completed in three clinical studies
and a new IND opened for ocular neuroprotection drug candidate QPI 1007:
-- Pfizer Inc., which licenses PF-4523655 from Quark, has completed
enrollment in a Phase 2 study of PF-4523655 in patients with diabetic
macular edema (DME). PF-4523655 is designed to inhibit the expression
of the Quark's proprietary target RTP801, a gene involved in abnormal
blood vessel development and leakage in the eye. Pfizer is also
conducting a Phase 2 study of PF-4523655 in patients with age-related
macular degeneration (AMD).
-- Quark has completed enrollment in two studies evaluating the safety of
QPI-1002 in different patient populations following systemic
administration. These include a Phase 1 study for the prevention of
acute kidney injury (AKI) in patients undergoing major cardiovascular
surgery, and Part A of a Phase 1/2 study in renal transplant patients
for the prophylaxis of delayed graft function (DGF). QPI-1002, designed
to temporarily inhibit the stress-response gene p53, is the first
systemically administered siRNA drug to enter human clinical trials.
Quark is poised to move forward with both programs in 2010.
-- Quark also announced that it expects to begin enrolling patients during
the first quarter of 2010 under its open IND, in a Phase 1 study of the
ocular neuroprotective agent QPI-1007. Quark's first siRNA drug
candidate with proprietary siRNA structure, QPI-1007, has been
evaluated in several models of ocular neuroprotection and shown to
protect retinal ganglion cells in an increased ocular pressure
preclinical model of glaucoma.
"Quark has maintained its leadership position in siRNA by advancing its clinical-
stage programs, and our momentum is accelerating as we enrich the Company's pipeline
and bring more product candidates into the clinic," said Daniel Zurr, Ph.D.,
President and Chief Executive Officer of Quark Pharmaceuticals. "Over the next 15
months, we anticipate at least one program may proceed into Phase 3 registration
studies, we will report data from multiple clinical studies and we plan to file our
fifth IND. We have demonstrated we have the right team and the right strategy, and we
are excited about the Company's future."
Dr. Shai Erlich, Quark's Chief Medical Officer, stated, "Quark's discovery and
development efforts remain focused on the goal of bringing novel and clinically
relevant therapeutic options to health care providers. We do this by addressing
molecular pathways that previously were not accessible to more traditional forms of
pharmaceutical modulation. Quark is generating novel siRNA drug candidates and is
pursuing a variety of delivery mechanisms to expand the scope of potential disease
applications while eliminating the need to depend on extensive drug modifications and
elaborate formulations that could reduce the therapeutic index for patients. To date,
preliminary results from Quark's Phase 1 clinical studies have shown few adverse drug
reactions and no treatment emergent dose-limiting toxicities. I look forward to the
next stage when the company reports completed study results findings in a range of
disease indications."
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc., is a leader in the discovery and development of
novel therapeutic RNAi drug candidates. Quark has a fully integrated drug development
platform that spans therapeutic target identification to drug development. The
Company's technology platform includes novel disease targets and siRNA structures and
chemistry, providing Quark with freedom to operate in the siRNA intellectual property
arena. Quark's approach to therapeutic delivery allows targeting of tissues and
organs including the eye, kidney, ear, lung, spinal cord and brain.
Quark's partner, Pfizer Inc, is advancing PF-4523655 (RTP801i-14), currently in
two Phase 2 clinical studies in patients with diabetic macular edema (DME) and age-
related macular degeneration (AMD). PF-4523655 is a synthetic, chemically modified
siRNA designed to inhibit the expression of the gene RTP801 that was discovered by
Quark through the gene discovery platform BiFAR(TM).
Quark's earlier-stage current clinical pipeline features QPI-1002, the first
systemically administered siRNA drug in human clinical trials. QPI-1002 is evaluated
for the prevention of acute kidney injury (AKI) following major cardiovascular
surgery and the prophylaxis of delayed graft function after kidney transplantation.
Enrollment was successfully completed recently in Phase I, respectively, Part A of a
Phase 1/2 studies in these indications. For the structure of these products, Quark
has licenses from Silence Therapeutics and from Alnylam Pharmaceuticals.
In the first quarter of 2010, Quark will begin a Phase 1/2 study of QPI-1007 as a
neuroprotective agent for eye diseases. QPI-1007 is a siRNA drug candidate that
utilizes a structure with freedom to operate in the siRNA intellectual property arena
developed in collaboration with BioSpring GmbH. In addition, Quark has a broad
pipeline of siRNA drug candidates that have arisen from Quark's research activities.
The Company is committed to development of novel siRNA structures and expects to
utilize these structures to develop additional RNAi drug candidates based on the
Company's productive R&D engine.
Quark is headquartered in Fremont, California and operates research and
development facilities in Boulder, Colorado and Ness-Ziona, Israel. Additional
Contact Information:
Quark Pharmaceuticals, Inc.
Juliana Friedman
+972 89 30 5111
jfriedman@quarkpharma.com
The Ruth Group (investors / media)
Sara Ephraim / Janine McCargo
(646) 536-7002 / 7033
sephraim@theruthgroup.com /
jmccargo@theruthgroup.com
SOURCE: Quark Pharmaceuticals, Inc.
CONTACT: Quark Pharmaceuticals, Inc.,
Juliana Friedman,
+972-89-30-5111,
jfriedman@quarkpharma.com;
or The Ruth Group (investors / media),
Sara Ephraim,
+1-646-536-7002,
sephraim@theruthgroup.com,
or Janine McCargo,
+1-646-536-7033,
jmccargo@theruthgroup.com
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