EntreMed Files New Drug Clinical Trial Application For ENMD-2076 With China SFDA To Advance Global Development Strategy
ROCKVILLE, Md., Jan. 7, 2013 /PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, announced today that EntreMed has submitted a new drug clinical trial application with China's State Food and Drug Administration (SFDA) for its proprietary drug candidate, ENMD-2076, to conduct global clinical trials in triple-negative breast cancer patients.
Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "We are very pleased with SFDA's acceptance of our application package and look forward to working with the SFDA to move the process forward towards approval. SFDA's approval of our application would pave the way for us to conduct global clinical trials in China and advance our ongoing Phase 2 triple-negative breast cancer trial currently underway at the University of Colorado and Indiana University.
"Our filing with SFDA represents an important milestone for us. As a clinical-stage drug development company, competition in patient recruitment, time, and costs can be challenging when advancing clinical programs. We address this by building a value-added platform via a joint US-China drug development model that will enable us to do the trials with lower study costs and faster patient recruitment. The data we obtain may be used to support both global drug development and China import drug registration as appropriate."
Dr. Ren continued, "We will also pursue developing ENMD-2076 in other indications where activity has been shown, including ovarian cancer, sarcoma and liver cancer, based on our prioritized product development plan. We believe positive results from these efforts will add value to our patients, shareholders, as well as to the company.
"In addition, we have initiated local manufacturing and pre-clinical activities of ENMD-2076 in China to target specific unmet medical needs, such as hepatocellular carcinoma, which could support a new drug trial application with SFDA. Our local development activities demonstrate EntreMed's commitment to develop a strong presence in the Chinese market, which has been projected to become the second largest pharmaceutical market in coming years. We believe we are on track with our development plan and are grateful to our shareholders for their enthusiasm, patience, and long term support."
EntreMed, Inc. 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 Aurora A and angiogenic kinase inhibitor for cancer, 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, Inc. recently initiated a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer. Its second compound, 2ME2, has been investigated in clinical trials in oncology patients, and was the subject of a successful IND filing for clinical use to treat RA in 2006. 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 FGFR3 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, leukemia, and multiple myeloma. ENMD-2076 is currently completing a Phase 2 trial for ovarian cancer. EntreMed, Inc. recently initiated a Phase 2 study of ENMD-2076 in triple-negative breast cancer.
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; 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 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.