EntreMed, Inc. Files New Drug Global Clinical Trial Application for ENMD-2076 With China CFDA to Expand Clinical Trial for Advanced/Metastatic Sarcoma
Published: Jun 27, 2013
ROCKVILLE, Md., 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 www.clinicaltrials.gov.
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 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."
"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 China 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 and China 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 Rockville, Maryland and has a wholly owned subsidiary in Beijing, China. Additional information about EntreMed is available on the Company's web site at www.entremed.com 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.
Forward Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed.
Actual results could differ materially from those currently anticipated due to a number of factors, including: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility of our common stock; the difficulty of executing our business strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidate or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; declines in actual sales of Thalomid® resulting in reduced or no royalty payments; risks associated with our product candidates; any early-stage products under development; results in preclinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission ("SEC"), which are available at www.sec.gov.
SOURCE EntreMed, Inc.
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