Navigation Links
Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans

Commences Phase I Clinical Trial of Proprietary siRNA Molecule in Acute

Renal Failure

FREMONT, Calif., Nov. 19 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company focused on discovering and developing novel RNA interference-based therapeutics, announced today that it has commenced systemic dosing in humans of its proprietary product candidate, AKIi-5, a siRNA compound discovered and developed by Quark for the treatment of Acute Renal Failure (ARF), also called Acute Kidney Injury (AKI). Based on publicly available information, Quark believes that this is the first human clinical trial involving the systemic delivery of siRNA.

The Phase I clinical trial is a multi-center, double-blind, placebo controlled, dose-escalation trial assessing the safety and pharmacokinetics of AKIi-5 administered intravenously as a single dose to patients undergoing major cardiac surgery. Patients will be enrolled in the trial in a number of centers in the United States, Europe and Israel. Quark expects to complete the trial in early 2008. Depending on the results of this trial, Quark expects to initiate a dose-ranging Phase II clinical trial measuring AKIi-5 clinical activity.

Daniel Zurr, Chief Executive Officer, commented, "The initiation of human dosing in our Phase I trial in ARF signifies a very important step in Quark's clinical program and marks an important milestone in the RNAi industry. For Quark, the trial serves to further validate the strength of our pipeline and our overall expertise in the RNAi arena. With AKIi-5 now in the clinic, RTP801i-14, which we licensed to Pfizer, in a Phase I/IIa clinical trial for the treatment of wet age-related macular degeneration, AHLi-11 in IND-enabling studies and additional RNAi-based candidate drugs in pre-clinical testing, we believe Quark has one of the most robust RNAi product portfolios in the industry.

"For the RNAi industry, the trial may be even more noteworthy as it represents the first documented systemic dosing of siRNA in humans. While the science of RNAi has been well-established, a key step in the acceptance of the technology as a promising therapeutic is the ability to deliver RNAi-based compounds systemically. We look forward to leading this important advance for the industry and, at the same time, continuing the development of this and other siRNA products in our pipeline."

Quark was granted an IND by the Food and Drug Administration (FDA) for AKIi-5 for the prevention of Acute Renal Failure in high-risk patients undergoing major cardiovascular surgery. AKIi-5 is a synthetic, chemically modified siRNA molecule discovered and patented by Quark that has an AtuRNAi technology-based structure licensed from Silence Therapeutics. Quark has also licensed certain intellectual property from Alnylam.

Quark has conducted pre-clinical studies of AKIi-5 for the prevention of acute renal failure in rats and monkeys. Rats treated with a single bolus injection of AKIi-5 were significantly protected from ischemia/reperfusion- induced acute kidney injury. In the rat studies, AKIi-5 effectively prevented the development of acute renal failure. Quark's pharmacokinetic, distribution, and toxicity studies in rats and monkeys indicate that AKIi-5 appears to have a favorable safety profile and has a relatively short residence time in the kidney.

About AKIi-5

AKIi-5 is a synthetic, chemically modified siRNA molecule designed to temporarily inhibit the expression of p53, a gene which plays a significant role in ARF by inducing tubular cell death (apoptosis) in response to injury. AKIi-5 is based on Quark's proprietary, patented concept of temporary and reversible inhibition, for therapeutic purposes, of the expression of the transcription factor human p53, which is associated with DNA repair and apoptosis. The concept was first published by Quark with the University of Illinois in a breakthrough paper in Science magazine (Science. 1999 Sep 10;285). Using RNA interference technology to temporarily inhibit p53 in acute settings such as acute kidney injury, apoptosis is delayed thereby allowing natural repair mechanisms to restore normal DNA and cellular integrity.

About Acute Renal Failure (ARF) / Acute Kidney Injury (AKI)

ARF is a syndrome characterized by a rapid decline of kidney function leading to death in a high percentage of cases. Major cardiac surgery is one of the many causes of ARF. During cardiac bypass surgery, lack of oxygen caused by reduced local blood flow to the kidneys, followed by rapid reintroduction of oxygen, or reperfusion, to the kidneys upon removal of the patient from cardiopulmonary bypass, initiates a chain of events that can lead to ARF. Currently, there are no approved drug therapies that effectively prevent or treat ARF.

About Quark Pharmaceuticals, Inc.

Quark Pharmaceuticals, Inc. is a development-stage pharmaceutical company focused on discovering and developing novel therapeutics based on its proprietary gene discovery science and technology, with an initial focus on drug candidates that work through the natural mechanism in the cell known as RNA interference, or RNAi, for the treatment of diseases associated with oxidative stress. Quark believes that its proprietary target gene discovery platform, BiFARTM, combined with its ability to design and successfully deliver synthetic molecules of the new class of RNAi therapeutics known as small-interfering RNA, or siRNA, to specific organs in the body, enables the Company to rapidly develop drug candidates. Quark has two internally discovered and developed clinical stage lead product candidates: RTP801i-14 in phase I/IIa clinical trial for the treatment of wet age-related macular degeneration, and AKIi-5 in phase I for the prevention of acute renal failure both of which have an AtuRNAi technology-based structure licensed from Silence Therapeutics, as well as a license from Alnylam. The Company has licensed RTP801i-14 to Pfizer on an exclusive worldwide basis. Quark has, in addition, a product candidate portfolio of RNAi therapeutics based on novel targets and therapeutic concepts discovered using BiFAR(TM) and designed for the treatment of oxidative stress associated diseases of the inner ear, lungs and additional organs of the body.

Quark is headquartered in Fremont, California and operates research and development facilities in Boulder, Colorado and Ness-Ziona, Israel. Additional information is available at

Quark Pharmaceuticals, Inc.

Gavin Samuels

(510) 449 6737

The Ruth Group

Stephanie Carrington / Elizabeth Scott (investors)

(646) 536-7017 / 7014

Janine McCargo (media)

(646) 536-7033

SOURCE Quark Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
2. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
3. Quark Pharmaceuticals Files Patent Application Covering Novel Chemical Modifications to its RNAi Molecules
4. Quark Pharmaceuticals Appoints New Chief Medical Officer
5. Quark Pharmaceuticals Signs Collaboration Agreement With University of Michigan for Development of Proprietary SiRNA Compounds for Noise-Induced Hearing Loss
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
8. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
9. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
10. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
11. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
Post Your Comments:
(Date:11/30/2015)... TOKYO , 1 décembre 2015 ... plus grande exposition et conférence d,Asie ... médicaux et sur l,industrie manufacturière, se ... du 20 au 22 avril ... - Photo - ...
(Date:11/30/2015)... Die MEDTEC Japan 2016, ... Entwicklung und Herstellung medizinischer Geräte, findet ... in Tokyo ... Foto: ... --> ...
(Date:11/30/2015)... 30, 2015 MEDTEC Japan 2016, Asia,s largest ... to be held in Tokyo from 20 th  - 22 nd April 2016. ... -->   --> --> ... the United States . With the aging population and the government back ... steadily. --> the United States . With the aging ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... Until now, the St. Louis ... the MOMS (Management of Myelomeningocele Study) trial. One of these exclusion criteria was a ... BMI of 18.5 to 24.9 is considered normal, 25 - 29.9 is overweight and ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... . The directory is specialized and only includes chiropractic clinics in the US. ... competent and trustworthy alternative health practitioner when back pain sets in. When people ...
(Date:11/30/2015)... Creek, Michigan (PRWEB) , ... November 30, 2015 , ... ... MI, the American Cancer Society held an annual fundraising event, a 5K walk known ... a holistic treatment center for substance abuse which is also located in Battle Creek, ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... a University of Delaware Accounting and Management of Information Systems course. Based in ... mid-market businesses. Sommer will speak at before student in the Enterprise Resource Planning ...
(Date:11/30/2015)... Baltimore, MD (PRWEB) , ... November 30, 2015 , ... ... has teamed up with Public Television’s Travel With Kids to promote ... follows the Simmons family as they explore international destinations and educate families about the ...
Breaking Medicine News(10 mins):