We are a late-stage biopharmaceutical company focused on the development and commercialization of our lead product candidate, entinostat, an epigenetic therapy for treatment-resistant cancers. Entinostat was recently granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) based on data from our completed randomized Phase 2b clinical trial in estrogen receptor positive locally recurrent or metastatic breast cancer. This trial showed statistically significant improvement in the primary endpoint of progression-free survival and showed statistically significant improvement in overall survival, an exploratory endpoint. We and our collaborators at the National Cancer Institute (NCI) will evaluate entinostat in a pivotal Phase 3 clinical trial in hormone receptor positive locally advanced or metastatic breast cancer, which we refer to as advanced breast cancer. The Phase 3 clinical trial will be conducted in collaboration with the Eastern Cooperative Oncology Group – American College of Radiology Imaging Network (ECOG-ACRIN Cancer Research Group) under sponsorship and funding support from the NCI. The protocol for the Phase 3 clinical trial was reviewed and agreed upon by the FDA under a Special Protocol Assessment agreement with the NCI in January 2014. ECOG-ACRIN Cancer Research Group activated the trial in March 2014 and we expect patient enrollment to begin in April 2014.
To further enhance our breast cancer program, we intend to conduct a Phase 2 clinical trial to further study the association between a potential biomarker of entinostat activity and clinical outcome, which we identified in our previous trial, and to explore entinostat’s use with another hormonal therapy. Additional investigator- and NCI-sponsored trials are being conducted to provide Phase 2 proof-of-concept data for entinostat in metastatic lung cancer and other solid and hematologic cancers. To date, we have efficacy and safety data for entinostat in more than 850 patients.