Syndax Pharmaceuticals, Inc. announced the publication in the Journal of Clinical Oncology of positive results of a phase 2 randomized, double-blind, placebo-controlled study of the company's lead drug entinostat. The study showed that entinostat extended both progression-free survival and overall survival when added to exemestane in postmenopausal women with estrogen receptor-positive (ER+) breast cancer whose cancer had progressed after treatment with a nonsteroidal aromatase inhibitor. The study evaluated entinostat in 130 postmenopausal women with advanced ER+ breast cancer, progressing on a nonsteroidal aromatase inhibitor. Patients were randomly assigned to 25 mg exemestane daily plus 5 mg entinostat once per week (64 patients), or exemestane plus placebo (66 patients). The primary end point was progression-free survival (PFS); blood was also collected in a subset of patients for evaluation of protein lysine acetylation as a biomarker of entinostat activity. Based on intent-to-treat analysis, patients treated with entinostat saw improved median PFS to 4.3 months, versus 2.3 months in patients treated with placebo (hazard ratio 0.73; 95% confidence interval, 0.50 to 1.07; one-sided P = 0.055; two-sided P = 0.11). Overall survival was an exploratory endpoint, and median survival improved to 28.1 months in entinostat-treated patients versus 19.8 months in placebo-treated (hazard ratio 0.59; 95% confidence interval, 0.36 to 0.97; P = 0.036). Fatigue and neutropenia were the most frequent grade 3/4 toxicities; treatment discontinuation because of adverse events was higher in the entinostat group versus the placebo group (11% versus 2%). Protein lysine hyperacetylation in the entinostat-treated biomarker subset was associated with prolonged progression-free survival.

Syndax Pharmaceuticals, Inc. Presents at 15th Annual Bio CEO & Investor Conference, Feb-11-2013 02:00 PM. Venue: The Waldorf Astoria, 301 Park Avenue, New York, NY 10022, United States. Speakers: Arlene M. Morris, Chief Executive Officer and Director.

Syndax Pharmaceuticals, Inc. Presents at Boston Biotech Conference CEO New York Conference, Nov-01-2012 through Nov-02-2012. Venue: Apella, 450 East 29th Street, New York, NY 10016, United States. Presentation Date & Speakers: Nov-01-2012, Arlene M. Morris, Chief Executive Officer and Director. Nov-02-2012, Arlene M. Morris, Chief Executive Officer and Director.