Quark Reports Progress Of siRNA Clinical Programs

Quark Pharmaceuticals has reported 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, 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).

Reportedly, QPI-1002, designed to temporarily inhibit the stress-response gene p53, is the first systemically administered siRNA drug to enter human clinical trials. Quark will move forward with both programs in 2010.

Quark also reported 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 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.

Daniel Zurr, president and chief executive officer of Quark, said: “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.

“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.”