Navigation Links
Isis Pharmaceuticals Reports Clinical Data Showing Blunting of Severe Increases in CRP Following Endotoxin Challenge With ISIS-CRP Rx
Date:3/13/2013

CARLSBAD, Calif., March 13, 2013 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that ISIS-CRPRx selectively reduced severe elevations in C-reactive protein (CRP) in humans.  Data from a Phase 1 clinical study showed that ISIS-CRPRx produced statistically significant, dose-dependent reductions in CRP response following an endotoxin challenge, which produces immune responses similar to those seen with bacterial infections.  In this study, significant reduction of the endotoxin-induced CRP response was achieved in the healthy volunteers treated with ISIS-CRPRx, with no changes in other important immune modulators, such as TNF-alpha, IL-6, and other cytokines and chemokines.  Selective reduction of CRP could offer a safer approach to treating patients who have chronic inflammatory diseases, such as rheumatoid arthritis, by potentially lowering the risk of infections, a common side effect of other anti-inflammatory drugs, such as TNF-alpha inhibitors.  A Phase 2 study of ISIS-CRPRx in patients with rheumatoid arthritis is currently underway with data anticipated in the middle of this year.

"The study illustrates the considerable specificity of antisense technology to target a single component of a complex immunologic response," said Dr. Paul Ridker of the Brigham and Women's Hospital and the Harvard Medical School.  "Thus, the approach shown to be effective here provides an opportunity to evaluate the role of CRP in different inflammatory disorders."

"This study is the first clinical demonstration of selective blunting of severe increases in CRP.  The fact that reductions in CRP can be achieved without affecting any other key inflammatory markers supports a potentially valuable profile for CRP inhibition in inflammatory diseases.  The selectivity of ISIS-CRPRx could translate into significant therapeutic benefit, especially in patients who, due to their disease, need to selectively reduce inflammation without suppressing critical immune system functions," said Richard Geary , Ph.D., senior vice president of development at Isis.

The Phase 1 study was a randomized, placebo-controlled, dose-response study designed to assess the effects of ISIS-CRPRx pretreatment on CRP levels following an endotoxin challenge in 30 healthy subjects.  ISIS-CRPRx was administered six times over the course of 22 days (days 1, 3, 5, 8, 15 and 22) at a dose of 400 mg or 600 mg.  At day 26, all subjects were administered an endotoxin challenge.  Key inflammatory markers were measured just prior to and after the challenge.  In this study, ISIS-CRPRx blunted severe increases in CRP levels by 63% (p=0.0011) in the 600 mg cohort and 36% (p=0.023) in the 400 mg cohort compared to placebo subjects at the time of peak CRP response (24 hours post challenge).  No changes in other inflammatory markers were observed.  Subjects receiving placebo had a mean baseline level of CRP of 1 mg/L and experienced robust, acute increases of CRP levels of greater than 30 times normal levels after the endotoxin challenge, which returned to baseline after 72 hours.  ISIS-CRPRx was well tolerated with no serious adverse events observed and no dose limiting toxicities.

"ISIS-CRPRx is the first drug to selectively reduce CRP protein in humans.  CRP levels are frequently elevated in many inflammatory diseases, and patients with chronic elevation of CRP have increased disease burden and worse outcomes.  As such, we believe that ISIS-CRPRx could provide patients with therapeutic benefit in numerous diseases with large commercial opportunities," said Stanley T. Crooke, M.D., Ph.D., chief executive officer and chairman at Isis. 

ISIS-CRPRx is currently being evaluated in a Phase 2 study in patients with rheumatoid arthritis, an autoimmune disease where CRP is chronically elevated.  In these patients, the degree of CRP elevation correlates with the severity of inflammation.  ISIS-CRPRx is also being evaluated in a Phase 2 study in patients with atrial fibrillation, a condition that involves an irregular and often rapid heart rate.  In patients with atrial fibrillation, elevated levels of CRP are associated with an increase in the severity of atrial fibrillation episodes.  By selectively lowering CRP in these diseases, ISIS-CRPRx could provide significant therapeutic benefit to these patients.  Isis plans to report data from the rheumatoid arthritis study in the middle of this year and from the atrial fibrillation study in the first half of 2014.

"Our Phase 2 program is designed to show benefit in diseases where elevated levels of CRP are predictive of disease severity, like atrial fibrillation and rheumatoid arthritis.  If positive, data from one or both of these studies will be evidence of the large potential of this drug in a variety of inflammatory diseases and conditions," concluded Dr. Crooke.  

ABOUT ISIS-CRPRx
ISIS-CRPRx is an antisense drug that is designed to inhibit the production of C-reactive protein (CRP).  For many years, CRP has been used as a clinical biomarker of disease activity with an inflammatory component, such as cardiovascular disease, Crohn's disease, rheumatoid arthritis and end-stage renal disease.  Elevated levels of CRP have been linked to coronary artery disease and a growing body of evidence from clinical trials implicated CRP in cardiovascular disease progression.  Although CRP's active participation in these diseases remains to be determined, several lines of evidence support a causal role of CRP in disease, suggesting that it may be therapeutically beneficial to decrease CRP levels. 

ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners.  Isis' broad pipeline consists of 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer.  Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO™, in the United States for the treatment of patients with HoFH.  Genzyme is also pursuing marketing approval of KYNAMRO in other markets, including Europe.  Isis' patents provide strong and extensive protection for its drugs and technology.  Additional information about Isis is available at www.isispharm.com.

ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the development, activity, therapeutic potential and safety of ISIS-CRPRx.  Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs, including the commercial potential of KYNAMRO, is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.  Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, which is on file with the SEC. Copies of this and other documents are available from the Company.

In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.  KYNAMRO™ is a trademark of Genzyme Corporation.


'/>"/>
SOURCE Isis Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
2. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
3. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
4. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
5. Icahn Issues Statement Regarding Amylin Pharmaceuticals
6. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
7. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Jazz Pharmaceuticals Announces First Quarter 2012 Financial Results Conference Call On May 8, 2012
10. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
11. Avanir Pharmaceuticals To Present at Three Conferences In May
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... , Dec. 5, 2016  Breckenridge Pharmaceutical, Inc. ... multi-product marketing agreement with development and manufacturing partner ... Under the terms of this agreement, Breckenridge will ... in the United States . ... tentatively-approved ANDA. The products cover a wide range ...
(Date:12/5/2016)... and PUNE, India , December ... report by Allied Market Research, titled, "Global Cancer Biomarkers Market ... revenue of cancer biomarkers market is projected to reach $15,737 ... CAGR of 13.3% from 2016 to 2022. Omic technologies segment ... 2015 and is expected to maintain its dominance during the ...
(Date:12/5/2016)... FRANCISCO , Dec. 5, 2016  Recently ... a methylation age predictor, known as Horvath,s Clock. ... offering a sample analysis service to academic and ... of any human sample, other than sperm. The ... to accurately estimate biological age versus chronological age ...
Breaking Medicine Technology:
(Date:12/6/2016)... ... December 06, 2016 , ... ... authorized OSHA Training Institute Education Center headquartered in Northern California, has announced the ... providing occupational safety and health training to public sector employees. , “The primary ...
(Date:12/5/2016)... , ... December 05, 2016 , ... "FCPX Overlay Glare ... but natural lighting effect without heavy rendering or complicated compositing," said Christina Austin - ... media to create an organic spectrum of lights that simulates the look of a ...
(Date:12/5/2016)... (PRWEB) , ... December 05, 2016 , ... ... announced it has been featured in SuperbCrew magazine, a leading online tech news ... world. This interview, now featured on SuperbCrew.com, explores the state of enterprise mobility ...
(Date:12/5/2016)... ... December 05, 2016 , ... “Epilepsy Awareness,” ... tomorrow, December 6th, sparks a conversation about epilepsy, bearing down on the social ... people will be diagnosed with epilepsy within their lifetime. With such a large ...
(Date:12/5/2016)... ... December 05, 2016 , ... ... lines. The goal of Castlewood Treatment Centers has always been to promote the ... as many people as possible. In that spirit, Castlewood has announced two new ...
Breaking Medicine News(10 mins):