Toxicogenomics – A Drug Development Perspective - Genomic Biomarkers for Pharmaceutical Development - page 138

TABLE 6.2 summary of Three Databases (Drugmatrix, TgP and PredTox)

DrugMatrix (Iconix) (USA) TGP (Japan) PredTox (EU)

Species Male Sprague-Dawley Rat Male Sprague-Dawley

Rat

Human
donor

Male Wistar rats

Study type in vivo in vitro in vivo in vitro in vitro in vivo

Dose type Daily repeated Single Daily

repeated

Single Single Single Daily repeated

Dose level 2 dose levels

(maximum
tolerated dose / fully
effective dose)

2 dose levels
(low, high)

3 dose levels (low, middle, high) 2 dose levels

(low, high)

Duration 1, 3, 5 days plus

some 7 days

6, 24 h 3, 7, 14,

28 days

3, 6, 9,
24 hr

2, 8,
24 hr

2, 8, 24 hr 1, 3, 14 days

# tested
compounds
in liver

343 chemicals
(mostly drugs)

126 chemicals
(mostly drugs)

131 chemicals
(mostly drugs)

119 14 proprietary

drug candidates
and two
reference toxic
compounds

Other
tissues

Kidney, heart,
thigh muscle, bone
marrow, spleen,
brain, intestine

NA Kidney Kidney, blood,

urine

Microarray
Platform

Affymetrix RG230-2.0 array and
CodeLink RU1 array

Affymetrix RG230-2.0
array

Affymetrix
human
U133 plus
2.0

Affymetrix
RG230-2.0
array

# arrays CodeLink: 5149

arrays
Affymetrix: 2216
arrays

~800 6264 6249 3140 2004 2300

Clinical
information

Histopathology;
body / organ weight;
food consumption;
hematology and
blood chemistry

NA Histopathology; body /

organ weight; food
consumption; hematology
and blood chemistry

NA Histopathology;

body / organ
weight; food
consumption;
hematology and
blood chemistry

Iconix Pharmaceutical (now a part of Entelos, San Mateo, CA) teamed with its partners and
built a database tracking rat gene expression profiles associated with toxic response based
on short-term, repeated-dose studies [219] . The database encompasses marketed and with-
drawn drugs, toxicants, and reference standards. The effort was aimed at providing requisite