Navigation Links
Quark Announces Dosing of the First Patient in Phase I Clinical Trial of its Ocular Neuroprotective Agent, QPI-1007
Date:3/1/2010

FREMONT, Calif., March 1 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced today the dosing of the first patient in a Phase I study of the investigational neuroprotective agent, QPI-1007.  This drug candidate, having a proprietary siRNA structure, is being developed for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION).  The current trial represents the seventh clinical study of Quark synthetic siRNAs.  QPI-1007 has been evaluated in several preclinical models of ocular neuroprotection, and has been shown in these models to protect retinal ganglion cells from injury-induced apoptosis.

The study is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug will be given to all patients who participate.  This study will determine whether QPI-1007 is safe when it is injected into the eye and will also reveal if there are any side effects of the drug and how long it takes for the body to clear the drug.  In addition, the study will examine the biological activity of the drug in NAION patients.  The study will enroll patients in two strata, and is being conducted in the U.S. and Israel.  Stratum I will enroll legally blind patients, while stratum II will enroll patients with recent onset of NAION.

Shai Erlich, Ph.D., Chief Medical Officer of Quark, commented, "Based on the pre-clinical results we've seen for QPI-1007, we are pleased to initiate dosing in human clinical trials. QPI-1007 is a siRNA molecule with Quark's proprietary structure and its entry into clinical trials reflects the Company's success in developing novel siRNA compounds.  These accomplishments further validate Quark's ability to advance innovative product candidates from discovery into the clinic."

Dr. Daniel Zurr, Quark's Chief Executive Officer, said, "The initiation of dosing in this trial brings the total number of siRNA programs in the clinic to five, an unprecedented number in the RNAi industry.  Beyond the size of our clinical stage siRNA portfolio, we are proud that this particular product, QPI-1007, was developed using entirely independent structural IP, further demonstrating our leadership in the field."

QPI-1007 is Quark's first siRNA drug candidate to utilize intellectual property developed internally in collaboration with BioSpring GmbH, and gives Quark freedom to operate in the siRNA IP space.  Preclinical studies have demonstrated a robust neuroprotective effect of QPI-1007 when administered immediately after injury induced by optic nerve crush or axotomy in two models of retinal ganglion cell (RGC) death as well as in a rat intraocular pressure (IOP) elevation model in which the drug was injected 2 weeks after IOP elevating operation.

About NAION

NAION is an acute ischemic disorder of the anterior optic nerve.  It is believed to be caused by acute ischemia of the optic nerve head resulting from insufficient arterial blood flow via the posterior ciliary artery.  Vision loss resulting from NAION is typically sudden, painless, and accompanied by pallid swelling of the optic disc.  In most cases patients have permanent severe visual deficits.  There is currently no approved treatment for NAION

About Quark Pharmaceuticals, Inc.

Quark Pharmaceuticals, Inc., is a leader in the discovery and development of novel RNAi-based drugs.  Quark has a fully integrated drug development platform spanning therapeutic target identification to drug development.  The Company's technology platform includes novel disease targets and siRNA structures and chemistry, providing Quark with freedom to operate in the siRNA intellectual property arena.  Quark's approach to therapeutic delivery allows targeting of tissues and organs including the eye, kidney, ear, lung, spinal cord and brain.

Quark's partner, Pfizer Inc, is advancing PF-4523655 (RTP801i-14), currently in two Phase 2 clinical studies in patients with diabetic macular edema (DME) and age-related macular degeneration (AMD).  PF-4523655 is a synthetic, chemically modified siRNA designed to inhibit the expression of the gene RTP801 that was discovered by Quark through the gene discovery platform BiFAR™.

Quark's clinical pipeline includes QPI-1002, the first systemically administered siRNA drug in human clinical trials. QPI-1002 is being evaluated for the prevention of acute kidney injury (AKI) following major cardiovascular surgery and for the prophylaxis of delayed graft function (DGF) after kidney transplantation.  Enrollment was successfully completed in a Phase I study and in the Part A portion of a Phase 1/2 studies in AKI and DGF, respectively.  Quark has licenses for the structure for these product candidates from Silence Therapeutics and Alnylam Pharmaceuticals.

In addition, Quark has a broad pipeline of siRNA drug candidates that have arisen from its research activities.  The Company is committed to development of novel siRNA structures and expects to utilize these structures to develop additional RNAi drug candidates based on its productive R&D engine.

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.       The Ruth Group (investors / media)
    Juliana Friedman                  Sara Pellegrino / Janine McCargo
    +972 89 30 5111                   (646) 536-7002 / 7033
    jfriedman@quarkpharma.com         spellegrino@theruthgroup.com
                                      jmccargo@theruthgroup.com

SOURCE Quark Pharmaceuticals, Inc.

Back to top

RELATED LINKS
http://www.quarkpharma.com

'/>"/>

SOURCE Quark Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Quark Reports Progress of siRNA Clinical Programs; 300 Patients Dosed With Quark Pharmaceuticals siRNA Drugs In Multiple Fully Enrolled Clinical Trials
2. Quark Pharmaceuticals to Present Data on its siRNA Therapeutic Programs in Kidney and Lung Diseases
3. Quark Pharmaceuticals Expands International Patent Protection for Compounds Targeting the RTP801 Gene
4. Quark Pharmaceuticals Presents at Asia TIDES Conference
5. Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function
6. Quark Pharmaceuticals Announces Publication of Study on Use of siRNA against Proprietary Target for Inhibiting Tumor Growth and Sensitization of Cancer Cells to Chemotherapy
7. Quark Pharmaceuticals Announces First RNAi Drug Candidate Having a Novel, Proprietary Structure Covered by Quark Intellectual Property
8. Silence Therapeutics to Receive $1.9m Milestone Payment as Pfizer and Quark Commence Phase II Trial
9. Quark Pharmaceuticals Announces First Patient Dosing by Pfizer in Phase II Trial of RNAi Therapy in Diabetic Macular Edema
10. Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
11. Quark Pharmaceuticals Signs Collaboration Agreement With University of Michigan for Development of Proprietary SiRNA Compounds for Noise-Induced Hearing Loss
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... , Kalifornien, 12. Februar 2016  Sequent ... der Aufnahme von Patienten für eine Studie zur ... Aneurysmen („WEB") speziell für die Behandlung von rupturierten ... , MD, Leiter der Neuroradiologie an der Universitätsklinik ... und Hauptprüfarzt der CLARYS-Studie hat den ersten Patienten ...
(Date:2/12/2016)... INDIANAPOLIS , Feb. 12, 2016  Eli Lilly and ... High Court decided the Alimta® (pemetrexed disodium) vitamin regimen patent ... in the UK, France , ... instructions to dilute the product only with dextrose solution.  ... of 2015, the UK Court of Appeal held that Lilly,s ...
(Date:2/12/2016)... February 12, 2016 ... auf den ungedeckten medizinischen Bedarf bei Lungen- ... seines klinischen Forschungsprogramms bekannt. Das Programm, das ... Verbesserungen ihrer respiratorischen Funktionen und anderer klinischer ... ein Medizintechnikunternehmen, das sich auf den ungedeckten ...
Breaking Medicine Technology:
(Date:2/12/2016)... Omaha, NE (PRWEB) , ... February 12, 2016 , ... ... list of the five most searched jobs via the website of healthcare staffing leader ... professionals in travel nurse jobs , travel therapy positions and in ...
(Date:2/12/2016)... ... February 12, 2016 , ... The aging population and ... long term care. With that, says Patrick Loughney, president of Longtree & ... in long term care environments. His company, which offers prep courses and workshops ...
(Date:2/12/2016)... ... 12, 2016 , ... Basketball is a game for everyone, not just those ... series, sign language translation is featured in the top right of the screen. Every ... lessons has a sign language translator to teach kids the game and how to ...
(Date:2/12/2016)... ... February 12, 2016 , ... With the exception of restorative dentistry, to date there has been ... the recent approval by the FDA, there is a now a new protocol in stopping ... is very simple and quick to apply. The application is as simple as drying ...
(Date:2/11/2016)... ... ... Fitbody Personal Training offers outdoor training classes which includes an equestrian boot ... healthy. Located in Phoenixville, PA, the classes are structured as fun and friendly. , ... want to lose weight and tone up. This class offers a balance of exercises ...
Breaking Medicine News(10 mins):