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Quark Pharmaceuticals Doses First Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Patient in Stratum II of its Clinical Study of siRNA Drug Candidate QPI-1007
Date:10/20/2010

FREMONT, Calif., Oct. 20 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in the discovery and development of RNAi-based therapeutics, today announced it has dosed the first patient with recent onset of non-arteritic anterior ischemic optic neuropathy (NAION) in its ongoing Phase I study of QPI-1007, the Company's proprietary synthetic siRNA drug candidate for ocular neuroprotection.

The Phase I open-label, dose-escalation study was initiated during the first quarter of 2010 to evaluate the safety, tolerability and pharmacokinetic profile of QPI-1007 in patients with chronic nerve atrophy (Stratum I) and recent onset NAION (Stratum II). Enrollment has been completed, with no dose-limiting toxicities observed, in five of the six cohorts of Stratum I.  Dosing at the highest planned dose level has been initiated in this patient population. Up to 30 NAION patients will be enrolled in Stratum II. In addition to safety and pharmacokinetic assessments, changes in visual acuity and visual field following the administration of QPI-1007 will be measured.

Dr. Daniel Zurr, Quark's Chief Executive Officer, stated, "After escalating to the highest planned dose of QPI-1007 in patients with chronic nerve atrophy, we are excited to dose the first NAION patient in our ongoing clinical study of QPI-1007, which has demonstrated significant neuroprotective activity in preclinical studies."

About the Phase I Study

The Phase I, open-label, dose-escalation study will assess the safety, tolerability, and pharmacokinetic profile of QPI-1007 in patients with chronic nerve atrophy (Stratum I) and recent onset NAION (Stratum II).  The study is expected to enroll up to 66 patients to receive a single intravitreal injection of QPI-1007 at varying doses with assessments of safety and tolerability for 12 months post-injection.  Secondary outcome measures include describing any anatomical changes in the optic nerve h
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SOURCE Quark Pharmaceuticals, Inc.
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