With IND Now Open, Fifth Clinical Study, in Ocular Neuroprotection, Set to Begin in 1Q10
Fremont, CA – November 19, 2009 – 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 BiFARTM.
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 atwww.quarkpharma.com.