FREMONT, Calif., Nov. 19 /PRNewswire/ -- 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:
“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 information is available at www.quarkpharma.com.
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
Web site: http://www.quarkpharma.com/
