Boston Biomedical, Inc. Announces the Continuation of the Phase 3 CanStem303C Study of Napabucasin in Patients with Advanced Colorectal Cancer Following Interim Analysis
- Category: Small Molecules
- Published on Friday, 07 June 2019 09:46
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CAMBRIDGE, MA, USA I June 6, 2019 I Boston Biomedical, Inc. today announced the continuation of the CanStem303C study evaluating the safety and efficacy of investigational agent napabucasin when given in combination with FOLFIRI with or without bevacizumab in patients with advanced colorectal cancer. This decision is based on a recommendation by the independent Data and Safety Monitoring Board (DSMB) to continue the study without modification following a pre-specified interim analysis of 50 percent of the total planned events. Boston Biomedical, Inc. has accepted this recommendation.
Napabucasin is an orally-administered investigational agent that is bioactivated by NQO1, which generates reactive oxygen species (ROS) to affect multiple oncogenic cellular pathways, including the STAT3 pathway, which is expected to result in cancer cell death.1
Napabucasin is currently being investigated in CanStem303C, a phase 3 trial for metastatic colorectal cancer (NCT02753127) and CanStem111P, a phase 3 trial for metastatic pancreatic cancer (NCT02993731). It is also being investigated in earlier phase trials in multiple solid malignancies. In 2016, the U.S. Food and Drug Administration granted Orphan Drug Designation for napabucasin in pancreatic cancer.
About Boston Biomedical, Inc.
Boston Biomedical, Inc. is a developer of novel cancer therapeutics with the goal of significantly improving patient outcomes. The company's most advanced research programs are focused on investigational agents that inhibit multiple oncogenic pathways, including cancer stemness pathways, and modifying immune responses. Headquartered in Cambridge, Massachusetts, Boston Biomedical, Inc. is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan.
Additional information about the company and its pipeline can be found at www.BostonBiomedical.com.
Disclaimer Regarding Forward-Looking Statements
The forward-looking statements in this press release are based on management's assumptions and beliefs in light of information presently available and involve both known and unknown risks and uncertainties. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
1 Chang, A., et.al (2019). Evaluation of Tumor Cell-Tumor Microenvironment Component Interactions as Potential Predictors of Patient Response to Napabucasin. Molecular Cancer Research.
SOURCE: Boston Biomedical