Boston Biomedical Inc, announced that the BRIGHTER Trial evaluating the efficacy and safety of napabucasin plus paclitaxel versus paclitaxel alone for patients with advanced gastric/GEJ (gastroesophageal junction) cancer will be unblinded.
This decision is based on a recommendation by the trial’s Data and Safety Monitoring Board (DSMB), following a pre-specified interim analysis on two-thirds of the total planned events. The DSMB determined that the study was unlikely to reach its primary endpoint of superior overall survival for napabucasin plus paclitaxel versus paclitaxel alone. No safety concerns were identified by the DSMB. Boston Biomedical has accepted this recommendation to unblind the study and plans to continue to follow all endpoints as defined in the protocol. Boston Biomedical will communicate further details to investigators shortly.
“Advanced gastric/GEJ cancer is a tumor type with a high unmet need, and our hope was to develop a new therapeutic option for these patients. We are disappointed with the results of this interim analysis. I want to express my gratitude to the trial participants, investigators, and staff for their efforts and contributions to this program,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. “We remain committed to our ongoing studies with napabucasin as well as our other first-in-class investigational compounds.”
Boston Biomedical intends to work with study investigators to complete a full evaluation of the BRIGHTER Trial results. Final data and analyses will be provided to regulatory authorities and will be presented and published for the oncology community.
About Boston Biomedical, Inc.
Boston Biomedical, Inc. was founded in November 2006 and is wholly owned by Sumitomo Dainippon Pharma Co., Ltd. Boston Biomedical’s mission is to develop the next generation of cancer therapeutics by creating drugs designed to target cancer stemness pathways. Boston Biomedical’s innovation in drug discovery has received a number of recognitions and awards in the United States, including the Frost & Sullivan 2010 North American Drug Discovery Technology Innovation of the Year Award, the National Cancer Institute (NCI) cancer stem cell initiative grant award in 2010, and the 2011 Biotech Pioneer Award at the Alexandria Oncology Summit. The company also received the “Company To Watch” award in the 10th Annual Team Massachusetts Economic Impact Awards in 2013. Boston Biomedical is headquartered in Cambridge, Massachusetts, USA.
Additional information about the company and its product pipeline can be found at www.BostonBiomedical.com
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