Iconix Study Drives Methods for Discovering and Validating Predictive Toxicology Biomarkers
23 Giugno 2006 - 3:20PM
PR Newswire (US)
Study by Iconix Scientists Receives 'Best Paper of 2005' Award From
Key Industry Journal Toxicologic Pathology MOUNTAIN VIEW, Calif.,
June 23 /PRNewswire/ -- Iconix Pharmaceuticals, Inc. today
announced that a study by Iconix scientists on the use of genomic
data to find biomarkers to predict adverse effects of drug
candidates has received the "Best Paper of 2005" award from the
well known industry journal Toxicologic Pathology. The paper
describes the discovery of a key biomarker that predicts kidney
toxicity weeks in advance of its occurrence, something that is not
possible with current toxicological methods. By providing all the
information required to enable other laboratories to further
validate the biomarker, the paper also addresses issues about the
use of genomic biomarkers that were raised in the FDA's "Guidance
for Industry: Pharmacogenomic Data Submissions," issued last year.
"By applying genomic biomarkers to identify toxicity issues we will
see substantial improvements in the costs, elapsed time and
prioritization process for moving the most promising drug
candidates forward for further development," said Dr. Donald
Halbert, head of R&D for Iconix. The paper is titled "A Gene
Expression Signature that Predicts the Future Onset of Drug-Induced
Renal Tubular Toxicity." The full reference can be obtained from
Iconix's website at http://www.iconixpharm.com/. The study
addresses key issues that many believe have been hampering the
widespread adoption of toxicity biomarkers, such as the use of a
sufficiently large dataset for biomarker derivation, and evaluation
on an independent data set to confirm the putative value of genomic
biomarkers. Specifically, the signature (biomarker) was derived
from short-term repeat dose studies in rats representing 64
nephrotoxic or non-nephrotoxic compounds. The signature, consisting
of only 35 genes, was then tested on independent samples from rats
treated with 21 structurally and mechanistically distinct compounds
with known positive or negative nephrotoxicity outcomes. The
signature correctly predicted the ability of test compounds to
induce tubular degeneration 76% of the time (in 16 of 21 test
compounds) before the pathology was detectable by standard clinical
and histological methods. This proof of concept study demonstrates
that genomic data can be more sensitive than existing methods for
the early detection of compound-induced pathology in the kidney and
is also significant as it sets the foundation for the development
of other predictive, and more sensitive, genomic biomarkers. "The
study was designed to evaluate whether genomics could indeed
predict drug-induced pathology weeks in advance of traditional
methods such as clinical chemistry and histological evaluation,"
said Mark Fielden, PhD, lead author on the study at Iconix
Pharmaceuticals. "What we've been able to demonstrate lends further
support for the use of genomic data to address the need for more
predictive tools in preclinical and clinical drug testing." The
paper published in Toxicologic Pathology comprehensively describes
the signature including all values necessary to allow additional
prospective validation by the research community. It is part of an
ongoing effort by Iconix to promote and confirm the broad value of
genomic biomarkers and their scientific accuracy via external
validation. The paper was selected for the Toxicologic Pathology
Best Paper award based on its general quality and on subject matter
that represents a significant advance by presenting a new concept
or method with important applications, one that is deemed likely to
be cited often in the literature for many years. The award signals
the growing acceptance of genomics by the pathology community and
the pharmaceutical industry overall. About Iconix Iconix
Pharmaceuticals, Inc., the leader in toxicogenomics products and
services, has pioneered the integration of chemistry and genomics
to enable the pharmaceutical and other industries to develop safer
drug candidates and compounds. The company's technologies increase
the odds of advancing the right candidates to the clinic, reduce
attrition rates in late stage trials and help keep the costs of
drug discovery in check. Iconix provides reference systems and
universally recognized expertise to predict toxic liabilities, side
effects and mechanisms of toxicity for drug candidates and
environmental chemicals. Iconix's DrugMatrix system has been
installed at the U.S. Food and Drug Administration for use by CDER
(Center for Drug Evaluation and Research) scientists and reviewers
in a range of toxicogenomics applications and is used by the US FDA
to evaluate voluntarily genomic data submissions. The company has
major research collaborations and technology alliances with Bristol
Myers Squibb, Abbott Laboratories, and Eli Lilly and has strategic
partnerships with leading life sciences companies including
Affymetrix, MDS Pharma Services (TSE:MDS)(NYSE:MDZ) and GE
Healthcare. Headquartered in Mountain View, California, Iconix was
founded in 1998 and is privately held. For more information, visit
http://www.iconixpharm.com/. Company Contacts: Iconix
Pharmaceuticals Alan Engelberg 650-567-5527 For Iconix
Pharmaceuticals Jennifer Larson 415-409-2727 DATASOURCE: Iconix
Pharmaceuticals, Inc. CONTACT: Alan Engelberg of Iconix
Pharmaceuticals, +1-650-567-5527, or ; or Jennifer Larson,
+1-415-409-2727, or , for Iconix Pharmaceuticals Web site:
http://www.iconixpharm.com/
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