Quark Pharmaceuticals, Inc., the world leader in clinical development of RNAi-based therapeutics, announced today that the independent Data Safety Monitoring Board ("DSMB") recommended that QPI-1002 (I5NP) continue on to the next phase of clinical testing. This followed review of available safety data from two clinical trials for Quark's siRNA QPI-1002, at doses up to 10 mg/kg, the highest evaluated to date. QPI-1002 is designed to temporarily inhibit expression of the stress-response gene, p53, and is the first systemically administered siRNA drug to enter human clinical trials.
The DSMB is an independent group of experts enlisted by Quark to review and evaluate the safety data generated from the dose-escalation portions of Quark's clinical program for QPI-1002. These include a Phase 1/2 study in renal transplant patients for the prophylaxis of delayed graft function (DGF) and the Phase 1 trial for prevention of acute kidney injury (AKI) in patients undergoing major cardiovascular surgery. The primary responsibility of the DSMB is to review data in order to make recommendations regarding the continuation, modification or termination of the trial due to safety concerns.
Daniel Zurr, Ph.D., President and Chief Executive Officer of Quark Pharmaceuticals, said, "The recommendation of the DSMB represents a landmark in the development of synthetic siRNAs, as QPI-1002 is the first siRNA to be administered systemically to humans. This recommendation by the DSMB enables Quark to move forward with our human clinical trials for QPI-1002 in both AKI and DGF. Quark has an established track record for taking siRNAs into human clinical trials at a rate unmatched in the industry. Part of the Company's ongoing mission is to bring novel and clinically relevant siRNA compounds to health care providers. By the end of 2010, Quark will have three compounds in clinical studies in five different disease indications, making Quark the industry leader in developing therapeutics in the Nobel Prize-winning field of RNAi."
SOURCE Quark Pharmaceuticals, Inc.