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Syndax Pharmaceuticals' Entinostat Shows Clinical Promise in Patients with Advanced Hormone Refractory Breast Cancer
Date:6/4/2010

WALTHAM, Mass., June 4 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, reported final results from the Phase 2, open-label ENCORE 303 trial in post-menopausal women with advanced, estrogen receptor (ER) positive breast cancer who were progressing on aromatase inhibitor (AI) therapy. Safety and efficacy results from the trial will be presented in a poster at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL tomorrow, Saturday, June 5, 2010.

"These findings are significant given that the patients enrolled were heavily hormonally pre-treated and relatively hormone resistant," said Joanna Horobin, president and chief executive officer of Syndax. "Resistance to AI therapy is multi-factorial and involves up-regulation of growth factor signaling pathways and down-regulation of estrogen receptor expression which may result from epigenetic modifications to the DNA and associated proteins. The disease stabilization achieved with the addition of entinostat supports our hypothesis that entinostat has the ability to normalize gene expression, thereby restoring sensitivity to targeted agents. We are optimistic that our ongoing ENCORE 301 study, a double-blind, randomized, placebo-controlled phase 2 study of entinostat in combination with the aromatase inhibitor exemestane, will provide further evidence supporting the clinical benefit and tolerability of entinostat in combination with aromatase inhibitors."

The primary endpoint of the study was Clinical Benefit Rate (CBR), defined as the proportion of patients who experience a complete or partial response or stable disease (SD) during the first six cycles of study treatment. Of the 26 evaluable patients in the ENCORE 303 stu
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SOURCE Syndax Pharmaceuticals, Inc.
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