EntreMed Files New Clinical Trial With CFDA For ENMD-2076

EntreMed, Inc. has submitted a new clinical trial application with the CFDA for its proprietary oncology drug candidate, ENMD-2076.

AsianScientist (Jul. 1, 2013) – EntreMed, Inc., a clinical-stage pharmaceutical company headquartered in Rockville, Maryland with a wholly owned subsidiary in Beijing, China, has submitted a new drug global clinical trial application with the China Food and Drug Administration (CFDA) for its proprietary oncology drug candidate, ENMD-2076.

ENMD-2076, a selective angiogenic kinase inhibitor, has completed several Phase I studies in solid tumors, multiple myeloma, and leukemia, and is currently completing a multi-center Phase II study in ovarian cancer.

EntreMed is currently conducting a Phase II study of ENMD-2076 in triple-negative breast cancer and a Phase II study of ENMD-2076 in advanced/metastatic soft tissue sarcoma. This submission is the Company’s second new drug global clinical trial application with the CFDA. The first application when approved will expand the Company’s Phase II clinical trial for triple-negative breast cancer which currently is being conducted at the University of Colorado and Indiana University in the United States.

“We are advancing our global development program in sarcoma because we believe that ENMD-2076, with its unique dual targets of Aurora A and VEGFR, may provide therapeutic benefits to the targeted patient population with unmet medical needs,” said Ken K. Ren, Ph.D., EntreMed’s Chief Executive Officer.

Ren added that the company is working with the Center for Drug Evaluation of the CFDA on the technical review and has begun laying out the groundwork for the trial, which is targeted to be launched by the fourth quarter of this year after approval is received.

“We are pleased with the continued execution of our integrated US-China drug development plan. Expanding our trials into China will enable us to explore the potential of ENMD-2076 at an accelerated pace due to faster patient recruitment and lower study costs, while obtaining data that will lead to advanced global drug development as well as China import drug registration,” he said.

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Source: EntreMed, Inc.
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