CARLSBAD, Calif., Feb. 23, 2011 /PRNewswire/ — Isis
Pharmaceuticals, Inc. (Nasdaq:
ISIS) announced today the results from a Phase 1 clinical trial
in which ISIS-CRPRx produced statistically significant reductions
in C-reactive protein (CRP) in the cohort of subjects in the study
with elevated CRP. In this study, ISIS-CRPRx was well
tolerated at doses up to 600 mg/week. Isis plans to evaluate
ISIS-CRPRx in Phase 2 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, before expanding into cardiovascular and
other diseases.
“CRP levels are increased in many inflammatory disorders, and
excessive amounts of CRP have been linked
to multiple clinical conditions, including cardiovascular
disease and diabetes,” said Paul M. Ridker, M.D., Eugene Braunwald
Professor of Medicine at the Brigham and Women’s Hospital and
Harvard Medical School. “This is the first evaluation of a
selective CRP inhibitor and the first such drug shown to be
active in man. What this new agent thus provides is a method to
directly test whether or not lowering CRP per se might be
beneficial for patient care, something that could not be addressed
in the past.”
The Phase 1 study of ISIS-CRPRx 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
(generally undetectable to less than 2 mg/L) CRP levels. In
the 600 mg per week multi-dose cohort, Isis enrolled eight
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