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

dy, one achieved a partial response (PR) and three achieved SD of greater than six months. The CBR of 15.4% exceeded the pre-specified rate of 5% defined in the study design with a p-value of 0.039. An additional six patients experienced SD between four and six months.

Secondary endpoints were objective response (OR) and progression-free survival (PFS), which were 3.9% and a median of 4.8 months, respectively. Overall survival, pharmacokinetics and correlation of selected biomarkers with clinical outcome were also measured. The most common adverse events considered to be related to entinostat were fatigue, nausea and diarrhea. No unexpected side effects were observed.

Syndax is also presenting two posters during the Society's new "Trials in Progress" session. These include abstract TPS128, which reviews ENCORE 301, a double-blind, randomized, placebo-controlled phase 2 study of entinostat in combination with exemestane, an aromatase inhibitor, in 114 post-menopausal women with ER positive metastatic breast cancer; and abstract TPS298, which reviews ENGAGE 501, an open-label, multicenter Phase 2 study in patients with Hodgkin's lymphoma. Data are anticipated from ENCORE 301 and ENGAGE 501 within 12 months.

Information regarding the ASCO presentations and full abstracts may be found on the ASCO website at http://abstract.asco.org/index20100505.html.

About Entinostat

Entinostat is an orally bioavailable, highly selective, class I histone deacetylase (HDAC) inhibitor with a long half-life that may allow for weekly or every-other-week dosing. Entinostat is currently being in
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SOURCE Syndax Pharmaceuticals, Inc.
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