Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing...( Commences Phase I Clinical Trial of...),Health

Commences Phase I Clinical Trial of Proprietary siRNA Molecule in Acute

Renal Failure

FREMONT, Calif., Nov. 19 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company focused on discovering and developing novel RNA interference-based therapeutics, announced today that it has commenced systemic dosing in humans of its proprietary product candidate, AKIi-5, a siRNA compound discovered and developed by Quark for the treatment of Acute Renal Failure (ARF), also called Acute Kidney Injury (AKI). Based on publicly available information, Quark believes that this is the first human clinical trial involving the systemic delivery of siRNA.

The Phase I clinical trial is a multi-center, double-blind, placebo controlled, dose-escalation trial assessing the safety and pharmacokinetics of AKIi-5 administered intravenously as a single dose to patients undergoing major cardiac surgery. Patients will be enrolled in the trial in a number of centers in the United States, Europe and Israel. Quark expects to complete the trial in early 2008. Depending on the results of this trial, Quark expects to initiate a dose-ranging Phase II clinical trial measuring AKIi-5 clinical activity.

Daniel Zurr, Chief Executive Officer, commented, "The initiation of human dosing in our Phase I trial in ARF signifies a very important step in Quark's clinical program and marks an important milestone in the RNAi industry. For Quark, the trial serves to further validate the strength of our pipeline and our overall expertise in the RNAi arena. With AKIi-5 now in the clinic, RTP801i-14, which we licensed to Pfizer, in a Phase I/IIa clinical trial for the treatment of wet age-related macular degeneration, AHLi-11 in IND-enabling studies and additional RNAi-based candidate drugs in pre-clinical testing, we believe Quark has one of the most robust RNAi product portfolios in the industry.

"For the RNAi industry, the trial m
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