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Quark Begins Enrollment in Glaucoma Drug Trial

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NEW YORK (GenomeWeb) – Quark Pharmaceuticals announced this week that it has dosed the first patient in a Phase IIa study of QPI-1007, its siRNA-based treatment for glaucoma.

QPI-1007 is composed of siRNAs designed to inhibit the pro-apoptotic gene caspase 2 and was first tested clinically as a treatment for non-arteritic anterior ischemic optic neuropathy (NAION), a rare disorder characterized by the death of retinal ganglion cells — the same cause of glaucoma-related blindness.

As it sets the stage for a Phase III trial in that condition, Quark has also been developing the drug for the more lucrative indication of glaucoma, but was able to skip Phase I testing because safety and tolerability data was already collected from a Phase I trial in NAION.

In the new Phase IIa study, approximately 60 patients with unilateral acute primary angle closure glaucoma will be randomized to receive either 1.5 mg intravitreal injections of QPI-1007 or a sham injection in one eye. Once their acute attacks have been treated by standard of care methods and the intraocular pressure in the study eye drops to an appropriate level, they will be treated.

The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics of QPI-1007 in glaucoma patients. "In addition, the biological activity of the drug will be studied by comparing the active group and control group study eyes at month 4 with respect to a series of visual function parameters," Quark added.

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