June 27, 2013
/PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of a variety of cancers, announced today that it 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. The purpose of the application is to expand the Company's Phase 2 clinical trial in advanced/metastatic sarcoma which currently is being conducted at Princess Margaret Hospital. 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 2 clinical trial for triple-negative breast cancer which currently is being conducted at the
University of Colorado
and Indiana University. More information about the clinical trials can be found at
Ken K. Ren
, Ph.D., EntreMed's Chief Executive Officer, commented, "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. We are excited about expanding the trial and are encouraged by the support from our investigators. We look forward to working with the CFDA to move our application forward towards approval. Regarding our application for triple-negative breast cancer, we are currently working with the Center for Drug Evaluation of CFDA on the technical review and have 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.
Dr. Ren continued, "We are pleased with the continued execution of our integrated US-China drug development plan. Expanding our trials into
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
import drug registration."
"In parallel with the advancement of our ENMD-2076 program," Dr. Ren further continued, "we are also evaluating additional drug candidates to add to our pipeline, with emphasis on compounds that have the potential for gaining widespread market acceptance globally or in
and for which development can be carried out cost-effectively under our global drug development strategy."
EntreMed is a clinical-stage pharmaceutical company employing a drug development strategy primarily in
the United States
to develop targeted therapeutics for the global market. Its lead compound, ENMD-2076, a selective angiogenic kinase inhibitor, has completed several Phase 1 studies in solid tumors, multiple myeloma, and leukemia, and is currently completing a multi-center Phase 2 study in ovarian cancer. EntreMed is currently conducting a Phase 2 study of ENMD-2076 in triple-negative breast cancer and a Phase 2 study of ENMD-2076 in advanced/metastatic soft tissue sarcoma. The Company is headquartered in
and has a wholly owned subsidiary in
, China. Additional information about EntreMed is available on the Company's web site at
and in various filings with the Securities and Exchange Commission (the SEC).
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 (cell division), and are often over-expressed in human cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR kinases which have been shown to play important roles in the pathology of several cancers. ENMD-2076 has shown promising activity in Phase 1 clinical trials in solid tumor cancers, including ovarian cancer, breast cancer, liver cancer, and sarcoma, as well as leukemia, multiple myeloma, and is currently completing a Phase 2 trial for ovarian cancer. EntreMed is currently conducting a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer and a Phase 2 study in advanced/metastatic soft tissue sarcoma. ENMD-2076 has received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia.