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 would be helpful to future development as a single agent, as well as consideration of any additional trials where ENMD-2076 could be combined with approved agents to increase clinical benefit,” Alex Zukiwski, CASI’s chief medical officer, said in a press release.
CASI said it will present the Phase 2 trial results at the next opportunity.
ENMD-2076 has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia, and hepatocellular carcinoma (HCC), the most common form of liver cancer.
The European Medicines Agency has also granted ENMD-2076 orphan drug status for the treatment of HCC, including fibrolamellar carcinomas, in the European Union.