FREMONT, Calif., March 14, 2016 /PRNewswire/ -- Quark Pharmaceuticals Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNA interference (RNAi)-based therapeutics, today announced that in the last month it has dosed the first patients in each of two pivotal Phase III studies – one for prevention and amelioration of the severity of Delayed Graft Function (DGF) in kidney transplant patients (ClinicalTrials.gov identifier: NCT02610296) and the other for the preservation of visual acuity in Acute Nonarteritic Ischemic Optical Neuropathy (NAION) (Clinical trials.gov identifier NCT02341560). In addition Quark said it started dosing in a Phase II study for the prevention of Acute Kidney Injury (AKI) in patients undergoing major cardiovascular surgery (Clinical trials.gov identifier NCT02610283).
"These key clinical development steps catapult Quark into the front line of all siRNA companies and brings closer the potential approval of the first siRNA drug, that may enter the market in 2018-2019," said Daniel Zurr, Ph.D., Chairman and Chief Executive Officer of Quark Pharmaceuticals.
Delayed Graft Function (DGF) Study with QPI-1002
Based on the largest ever Phase II Study (326 subjects) conducted by Quark, the company met with FDA and EMA and reached agreement on the study design and endpoint for this confirmatory study. The study involves approximately 75 hospitals in North America, Latin America, Australia and Europe. Quark has received Orphan Drug status by the FDA and the EMA for this indication.
Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Study with QPI-1007
The pivotal Phase II/III study is being conducted at approximately 66 hospitals in the U.S., Europe, Israel, India and China. The approval for this study by the Indian (DCGI) and Chinese (CFDA) health authorities marks a major milestone because it is the first time that an siRNA molecule was approved by these authorities to be used in humans in clinical studies. Quark received Orphan Drug status from the FDA on this indication. The siRNA drug molecule is based on Quark's unique new proprietary structure.
Acute Kidney Injury (AKI) Study with QPI-1002
The Phase II study is taking place at approximately 40 hospitals in North America. QPI-1002 was the first-ever siRNA molecule dosed systemically in clinical studies under an FDA Investigational New Drug Application.
Additional details shall be published separately.
RNA interference (RNAi) is a universal mechanism within living cells that employs non-coding RNA to control which genes are active and how active they are. This natural mechanism, which was discovered in 1998 and was awarded the Nobel Prize in 2006, has already revolutionized experimental biology and currently holds the highest promise for therapeutic purposes. Various types of short double-stranded RNAs act as effector molecules of the RNAi mechanism. Some of them, targeting specific genes in a sequence-dependent manner and inhibiting their expression, are called small interfering RNAs (siRNAs). siRNAs can be designed based on the sequence information of virtually any gene, produced synthetically and used as drugs. siRNA drugs can cause inhibition of expression of any gene, regardless of its traditional attribution to potentially "druggable" or "non-druggable" targets. These drugs are highly specific and potentially safer than other drugs such as promiscuous small molecule therapies.
About Quark Pharmaceuticals Inc.
Quark Pharmaceuticals Inc. is a late clinical-stage pharmaceutical company engaged in discovering and developing novel RNAi-based therapeutics. Quark has a fully integrated drug development platform spanning therapeutic target identification to drug development. Quark's RNAi technology includes novel siRNA structures and chemistry providing Quark with freedom to operate in the siRNA intellectual property arena, as well as the ability for non-invasive delivery of siRNA to other target tissues including the kidney, heart, eye, ear, lung, spinal cord, hair follicles and brain. Quark is headquartered in Fremont, California, and operates research and development facilities in Ness-Ziona, Israel. Please visit www.quarkpharma.com for more information.
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SOURCE Quark Pharmaceuticals Inc.