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Quark Kidney Transplant Drug Receives FDA Orphan Drug Status


Quark Pharmaceuticals announced this week that the US Food and Drug Administration has granted an orphan drug designation to the company's p53-targeting siRNA QPI-1002 as preventative of delayed graft function in kidney transplant patients.

The designation, Quark said, allows for possible research and development incentives, and qualifies the company for tax credits and a period of market exclusivity following market approval.

Quark said that it has completed dosing in the dose-escalation portion of a phase I/II trial of the drug, and that it has received a positive recommendation from an independent data safety monitoring board to progress the drug to the second portion of the study, which will evaluate the safety and potential clinical activity of QPI-1002.