« Return to News | Clinical Intelligence

Isis Pharmaceuticals reports phase I study results

Tuesday, March 8, 2011 10:39 AM

Isis Pharmaceuticals announced the results from a phase I clinical trial in which ISIS-CRPRx produced statistical reductions in C-reactive protein (CRP) in the cohort with elevated CRP.  ISIS-CRPRx was well tolerated at doses up to 600 mg/week.  Isis plans to evaluate ISIS-CRPRx in phase II studies in indications that could provide early proof-of-concept in diseases with elevated CRP.  Isis plans to initially evaluate ISIS-CRPRx in multiple myeloma and rheumatoid arthritis, and then move to cardiovascular and other diseases.

The phase I study was a blinded, randomized, placebo-controlled, dose-escalation study designed to assess the safety and pharmacokinetic profile of ISIS-CRPRx as well as to assess the initial effects of the drug on baseline CRP levels.  ISIS-CRPRx was evaluated in single and multiple doses ranging from 50 mg per week to 600 mg per week in 80 healthy volunteers.  In all but one cohort, Isis enrolled subjects who had normal CRP levels.  In the 600 mg per week multi-dose cohort, Isis enrolled eight subjects with elevated levels of CRP.  The subjects in this cohort had an average CRP level at baseline of approximately 3.0 mg/L. 

After only three weeks of dosing, the six subjects who received ISIS-CRPRx had an average CRP level of 0.76 mg/L, which is within the normal range of CRP and represents an average reduction of greater than 70% compared to placebo.  Subjects receiving placebo remained elevated above 3.0 mg/L.  In all subjects receiving the drug, it was well tolerated with no serious adverse events.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

May 20

IRB consolidation trend continues, as private equity firm Audax buys majority stake in Chesapeake

Quintiles, Merck Serono ink exclusive partnership

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

May

INC Research, PPD, inVentiv named top CROs
Yet most CROs slipping in ability to manage site relationships

R&D cuts by sponsors spur more collaboration, innovation
New strategies share pipeline activity costs

Already a subscriber?
Log in to your digital subscription.

Purchase the May issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

April

20 innovators changing the face of the clinical trials industry
The CenterWatch Monthly honors individuals, teams and companies for their forward-thinking ideas and their ability to implement them.

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.