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Quark Pharmaceuticals Reports Favorable Interim Results from Phase I Clinical Study of QPI-1007 in Patients with Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Date:1/4/2012

FREMONT, Calif., Jan. 4, 2012 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced interim results from the first two cohorts of its Open Label, first-in-human Phase I clinical study of QPI-1007, the Company's proprietary synthetic siRNA drug candidate for ocular neuroprotection, in patients with recent onset of non-arteritic anterior ischemic optic neuropathy (NAION).  QPI-1007 exhibited no dose limiting toxicities up to and including the highest dose of 6 milligrams enabled in this study, which is the highest dose of synthetic siRNA tested in the clinic following intravitreal administration.  After 3 months of follow up, patients treated in the study by a single dose of QPI-1007 exhibited no further loss of visual acuity, whereas vision loss was observed in previous studies(1) in non-treated NAION patients with similar initial disease severity. With the exception of one patient whose vision remained stable, all patients exhibited letter gains compared to baseline at screening, with some patients gaining 3-lines or more by 3 months after treatment.

The ongoing Phase 1 open-label, dose-escalation study, which is being conducted in 22 sites in the USA and 6 sites in Israel, has enrolled a total of 38 patients in two strata: Stratum I was a dose-escalation safety study in patients who are legally blind secondary to chronic optic nerve atrophy or retinal degeneration and is fully enrolled; Stratum II was designed to further evaluate safety and to assess for potential biological activity of QPI-1007 in recent-onset NAION patients by monitoring changes in visual function  following drug administration.

In Stratum II, two cohorts of ten patients each were given a single intravitreal injection of one of two doses of QPI-1007. After one month of follow-up, 40% of patients in Cohort 1 and 60% of patients in Cohort 2 gained 3 or more lines of visual acuity. At
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SOURCE Quark Pharmaceuticals, Inc.
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