Dosing Initiated at Highest Planned Dose in Chronic Nerve Atrophy Patient Group
Fremont, CA October 20, 2010, – 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 head and retina and assessment of changes in visual acuity and visual field observed following the administration the drug.
NAION is an acute ischemic disorder of the optic nerve for which there is currently no approved treatment. It is believed to be caused by insufficient arterial blood flow to the optic nerve via the posterior ciliary artery. Vision loss resulting from NAION is typically sudden and painless, and in most cases patients have permanent visual deficits.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc., is a clinical-stage pharmaceutical company engaged in discovering and developing novel RNAi interference or RNAi-based therapeutics. The Company has a fully integrated drug development platform that spans therapeutic target identification based on its proprietary gene discovery science and technology, to clinical drug development. The Company has initially been focusing on RNAi-based therapeutics for the treatment of diseases associated with oxidative stress and ischemic injury. Quark has three product candidates in clinical development in five different indications.
Quark is committed to leveraging a broad research pipeline of siRNA drug candidates and novel siRNA structures to develop additional RNAi drug candidates.
Quark is headquartered in Fremont, California and operates research and development facilities in Boulder, Colorado and Ness-Ziona, Israel. Additional information is available at www.quarkpharma.com.
|Quark Pharmaceuticals, Inc.
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