Quark Pharmaceuticals Announces The Presentation Of Data Indicating Potential Utility Of Qpi-1002 In

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10th June 2009, 01:21am - Views: 766

Community Health Quark Pharmaceuticals, Inc. 1 image


Quark Pharmaceuticals Announces the Presentation of Data Indicating Potential Utility of QPI-1002

in Chronic Kidney Disease at the RNA Interference Summit

FREMONT, Calif., June 9 /PRNewswire-AsiaNet/ --

    Quark Pharmaceuticals, Inc., a development-stage pharmaceutical company discovering and developing

novel RNA interference (RNAi)-based therapeutics, today announced that Bruce A. Molitoris, M.D., Director,

Division of Nephrology and Professor of Medicine, Indiana University, will present data demonstrating

efficacy in models of acute and chronic kidney disease (AKI and CKD, respectively) of an animal analogue

of QPI-1002 at the RNA Interference Summit being held June 8-10, 2009 in San Francisco, CA. QPI-1002,

a siRNA drug candidate being developed by Quark Pharmaceuticals, Inc. is the first systemically-

administered siRNA to enter human clinical trials. The drug is the subject of two multi-center Phase I

studies for acute kidney injury (AKI) and one Phase I/II study for delayed graft function (DGF) in kidney

transplantation. QPI-1002 targets p53, a gene that plays a pivotal role in the stress-response apoptotic


    Using intravital 2-photon in life microscopy to follow the distribution

of fluorescent labeled siRNA in the rat kidney, Prof. Molitoris demonstrated

rapid and predominant distribution of the siRNA to kidney proximal tubular

cells (PTC), which are the main type of suffering cells in the context of

ischemic or toxic kidney injury. Dose response and time course studies

exploring efficacy of the animal analogue of QPI-1002 in the AKI models in

rats indicated excellent efficacy of the drug in reducing serum creatinine

levels and ameliorating acute morphological damage to the kidney including

PTC death. The data indicate that recurrent dosing of the drug concomitantly

with monthly repetitive ischemic kidney insults minimizes the resulting

kidney injury and can attenuate development of associated chronic kidney

disease (CKD).

    Daniel Zurr, Chief Executive Officer, commented, "We are excited to see

this as a possible additional indication for QPI-1002; the compound is

already being studied as the first systemically-dosed siRNA to be tested in

humans for AKI following major cardiovascular surgery, and for delayed graft

function (DGF) following kidney transplantation. CKD is a very serious

condition leading to kidney failure and complications such as cardiovascular

disease (CVD). In America alone, 26 million adults suffer from CKD and

millions of others are at increased risk. We are eager to continue these

studies to provide a remedy for this disease."

    Dr. Molitoris said, "The current standard of care in the treatment of CKD

is to help slow the rate of damage to the kidneys by treating the condition

causing the disease and to modify the patient's diet and exercise. I'm

excited by these data indicating that QPI-1002 could be an additional

therapeutic tool to minimize the AKI associated progression of chronic kidney

disease, which inevitably leads to loss of kidney function and development

end stage renal disease that necessitates dialysis or a kidney transplant to

maintain life. It would be gratifying to see a treatment that directly

targets the condition of CKD, regardless of the underlying cause."

    About QPI-1002

    QPI-1002 is a synthetic, chemically modified siRNA molecule based on

Quark's proprietary, patented invention of temporarily and reversibly

inhibiting a master stress-response gene p53. QPI-1002 drug is also protected

Community Health Quark Pharmaceuticals, Inc. 2 image

by Quark's patents. Temporary inhibition of p53 at the time of injury delays

massive death of vulnerable affected cells, allowing natural repair

mechanisms to take over, thus preserving tissue integrity and function. In

acute kidney injury (AKI), the p53 gene induces tubular cell death resulting

in kidney dysfunction. In the context of AKI, RNA interference (RNAi)

technology used to temporarily inhibit p53 exploits the siRNA property to

predominantly accumulate in target renal cells that activate p53 and are

consequently prone to death. In collaboration with the University of Illinois

at Chicago, Quark first published its therapeutic concept in a seminal paper

in Science magazine (Science. 1999 Sep 10; 285).

    About Quark Pharmaceuticals, Inc.

    Quark Pharmaceuticals, Inc. is a development-stage pharmaceutical company

engaged in discovering and developing novel RNAi-based therapeutics. Quark

has a fully integrated drug development platform that spans 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 eye,

ear, lung, and CNS.

    In addition to QPI-1002, Quark's clinical pipeline includes PF-4523655

(RTP801i-14), licensed to Pfizer, which is currently in Phase II clinical

trials in 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 discovered by Quark through the

gene discovery platform BiFAR(TM). For the structure of these products, Quark

has licenses from Silence Therapeutics and from Alnylam Pharmaceuticals.

QPI-1007, a siRNA that utilizes a proprietary structure developed by Quark,

is being evaluated in IND-enabling nonclinical studies as a neuroprotective

agent for eye diseases. In addition, Quark has a broad pipeline of siRNA drug

candidates based on internally developed novel structures.

    Quark is headquartered in Fremont, California and operates research and

development facilities in Boulder, Colorado and Ness-Ziona, Israel.

    Quark Pharmaceuticals, Inc.       The Ruth Group (investors / media)

    Juliana Friedman                  Sara Ephraim Pellegrino / Janine McCargo

    +972 89 30 5111                   (646) 536-7002 / 7033

    jfriedman@quarkpharma.com         spellegrino@theruthgroup.com


SOURCE: Quark Pharmaceuticals, Inc.

    CONTACT: Juliana Friedman of Quark Pharmaceuticals, Inc., 



             Sara Ephraim Pellegrino, 



             or Janine McCargo, 




             both of The Ruth Group (investors / media)

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