Orphan drug designation granted to QPI-1002 for delayed graft function (DGF) in kidney transplant

Quark Pharmaceuticals was granted orphan drug designation by the FDA for its synthetic siRNA drug candidate, QPI-1002 (I5NP), for the prophylaxis of delayed graft function (DGF) in kidney transplant patients.  Quark has completed enrollment and dosing in the dose-escalation safety portion (Part A) of a Phase 1/2 study and has received a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to progress the drug to the second portion (Part B) of the study to evaluate the safety and potential clinical activity of QPI-1002.

QPI-1002, the first systemic siRNA drug to enter human clinical trials, is designed to temporarily inhibit the expression of the pro-apoptotic gene, p53, to protect normal cells from acute injury. Preclinical studies have shown that p53-targeted siRNAs can protect kidneys from ischemia/reperfusion injury that can occur following transplantation.

For more information call (510) 402-4020 or visit www.quarkpharma.com.