CASI Pharmaceuticals Announces Initiation of Phase II Trial With ENMD-2076

CASI Pharmaceuticals, Inc. recently announced that it has initiated a Phase II trial of its target therapy drug candidate ENMD-2076 in triple-negative breast cancer (TNBC) at the Cancer Hospital of Chinese Academy of Medical Sciences in Beijing, China. Binghe Xu, MD, PhD, Professor and Director of the Department of Medical Oncology at the Cancer Hospital of Chinese Academy of Medical Sciences is the principal investigator of the trial.

This Phase II trial is an expansion of the current US Phase II trial that is underway at the University of Colorado Cancer Center and the Melvin and Bren Simon Cancer Center at Indiana University. The China trial will assess safety and efficacy of ENMD-2076 in the Chinese patient population with correlative bio-marker analysis.

“We are very pleased that we have initiated the first clinical trial in China for ENMD-2076 and very much look forward to see how it might benefit Chinese patients,” commented Rong Chen, MD, PhD, CASI’s Chief Medical Officer. “Data from this China study will bolster data that is currently being collected at the two US sites and will provide valuable information as we continue the development of ENMD-2076 for this cancer indication.”

“We are very pleased and thankful to Dr. Xu and the Cancer Hospital of Chinese Academy of Medical Sciences for taking the lead in our China trials,” added Ken K. Ren, PhD, CASI’s Chief Executive Officer. “Their experience in clinical research of solid tumors, especially in breast cancer, as well as expertise in clinical trials of new anticancer agents will be invaluable to the trial going forward in China as well as to our overall global development program.”

ENMD-2076 is an orally active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. Aurora kinases are key regulators of mitosis and are often over-expressed in human cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases, which have been shown to play important roles in the pathology of several cancers. ENMD-2076 has shown promising activity in Phase I clinical trials in solid tumors, including ovarian, breast, liver, renal, and sarcoma, as well as in leukemia and multiple myeloma. ENMD-2076 is currently in Phase II clinical trials in multiple indications, including triple-negative breast cancer, soft tissue sarcoma, and ovarian clear cell carcinomas and is preparing for a Phase II trial in Fibrolamellar Carcinoma (FLC). ENMD-2076 has received orphan drug designation from the US FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia, and hepatocellular carcinoma.

CASI is a biopharmaceutical company dedicated to the acquisition, development, and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China. CASI’s product pipeline includes exclusive rights to ZEVALIN (ibritumomab tiuxetan), MARQIBO (vinCRIStine sulfate LIPOSOME injection), and Captisol-Enabled (propylene glycol-free) melphalan (CE melphalan) for greater China (including Taiwan, Hong Kong, and Macau). CASI’s development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase II oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation development. CASI is headquartered in Rockville, MD, and has a wholly owned subsidiary and R&D operations in Beijing, China. For more information, visit www.casipharmaceuticals.com.