CASI Closes Patient Enrollment in Study of ENMD-2076 for Triple-Negative Breast Cancer

CASI Closes Patient Enrollment in Study of ENMD-2076 for Triple-Negative Breast Cancer
CASI Pharmaceuticals has closed enrollment in its Phase 2 clinical trial of ENMD-2076 for previously treated locally advanced or metastatic triple-negative breast cancer (TNBC). The 41 American patients it has enrolled so far are enough for the study (NCT01639248), CASI said. It continues to enroll patients in an arm of the trial in China, however. University of Colorado and Indiana University Melvin and Bren Simon Cancer Center researchers are leading the Phase 2 trail investigation. CASI reached the 41-patient level in the United States after expanding the threshold of the trial to include patients who weren't eligible for the study under the original protocol that researchers had drawn up. The company believes 41 patients will be enough to assess the effectiveness of ENMD-2076 and to continue the biomarker analysis that is also part of the study. CASI wants to identify biomarkers that can help it predict patients' response to ENMD-2076. Meanwhile, the company is continuing to enroll patients in the Phase 2a arm of the study in China. At the moment the study there is in a dose escalation phase. Researchers are looking at ascending doses of ENDM-2076 to determine the best one for studying the drug's effectiveness. The company expects to reach the targeted enrollment in the Chinese arm of the trial by the third quarter of the year. "We continue to evaluate the maturing data, including the biomarker analysis, to determine the potential future development path in patients with TNBC. Identifying markers predictive of response to ENMD-2076 in patients with TNBC wo
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