press release: New Data Indicate Effectiveness of Clarient's Ovotax(TM) Test for Ovarian Cancer "TLE3"

The study summary and results may be found at http://www.clarientinc.com/Ovotax

ALISO VIEJO, Calif., March 17 /PRNewswire-FirstCall/ -- Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that data from a new study shows that Clarient's Ovotax™ assay may effectively predict which ovarian cancer patients will respond favorably to taxane therapy and could, therefore, be spared the potential side effects of this rigorous and sometimes toxic chemotherapy agent. The study was presented yesterday at the national meeting on Women's Cancer of the Society of Gynecologic Oncologists by Janelle Fauci, M.D. of the Department of Obstetrics and Gynecology at the University of Alabama, Birmingham (UAB).

The study, titled "Expression of TLE3 Predicts Response to Taxane Therapy in Ovarian Carcinoma," included 293 carcinoma samples. Ovotax is a single antibody immunohistochemistry test created to detect the expression of TLE3 in an ovarian tumor and thereby indicate whether the patient will respond favorably to taxane therapy.


The study summary and results may be found at http://www.clarientinc.com/Ovotax

"Results (click on the link above for the poster - pdf file)

• 583 patients were enrolled across both cohorts
• 273 patients were eligible for analysis
‒ 71% (193/296) were treated with a taxane containing regimen
‒ 31% patients expressed TLE3
• TLE3 expression was associated with improved time to recurrence in taxane
treated patients (HR=0.62, p=0.018) (Figure 2a)
‒ After 5 years, 36% of TLE+ patients were recurrence-free versus 14% of
TLE3- patients
‒ An interaction test between TLE3 expression and response to therapy
was statistically significant (p=0.024)
‒ No relationship with outcome was found in patients treated with a platinum
agent only or untreated (n=103 HR=1.24 p=0.24) (Figure 2b)

Conclusions:
• TLE3 expression is predictive of taxane response in ovarian carcinoma,
with a stronger association noted in those tumors exhibiting non-serous
histologies.
• TLE3 expression is associated with a statistically significant longer diseasefree
interval when these patients are treated with a taxane regimen
• Future studies are needed to establish whether the association between
TLE3 and response to taxane therapy is more prevelant in any one nonserous
subtype.
‒ Clinical studies with cohorts of non-serous histologies are rare,
therefore follow-up prospective trials using taxane regimens stratified
by TLE3 expression are needed to confirm TLE3 as a useful biomarker
for taxane sensitivity.