Data Presented For ENMD-2076 In Xenograft Models Of Human Hepatocellular Carcinoma
ROCKVILLE, Md., Oct. 22, 2013 /PRNewswire/ -- EntreMed, Inc. (NASDAQ: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of a variety of cancers, announced today the presentation of preclinical data for a study comparing the efficacy of ENMD-2076 against that of standard of care agents including sorafenib, doxorubicin, and 5-FU for human hepatocellular carcinoma (HCC) models. The results of the study were presented at AACR-NCI-EORTC International Conference being held this week in Boston, Massachusetts.
The data presented demonstrate significant in vivo activity of ENMD-2076 against three different human hepatocellular carcinoma xenograft models and concluded that ENMD-2076 showed robust antitumor activity against the cell line-derived xenograft models of human HCC superior to that of sorafenib, doxorubicin, and 5-FU.
Ken K. Ren, Ph.D., EntreMed's Chief Executive Officer, commented, "HCC represents the third leading cause of cancer deaths worldwide. There are unmet medical needs for drugs with better safety and efficacy. This in vivo preclinical study data is affirmative with our previous in vitro findings that greater than 60% of 21 liver cancer-derived cell lines we screened are significantly inhibited by ENMD-2076 treatment. It also indicates that ENMD-2076 may be effective in patients resistant to sorafenib or 5-FU. In our Phase 1 trial of ENMD-2076, partial response with prolonged progression free survival was observed in a patient with liver cancer who relapsed from standard care including liver transplantation and sorafenib treatment. This preclinical study provides support for further clinical investigation of the drug candidate in HCC patients who do not tolerate, or have failed or relapsed from other systemic treatment, particularly sorafenib or 5-FU. We believe that ENMD-2076 has potential in the HCC market, especially in China, where more than 50% of global incidence occurs."
To view the poster presentation, visit the Company's website at http://www.entremed.com.
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, multiple myeloma, and is currently completing a Phase 2 trial for ovarian cancer. EntreMed is currently conducting a Phase 2 study of ENMD-2076 in triple-negative breast cancer, a Phase 2 study in advanced/metastatic soft tissue sarcoma, and expecting to initiate a Phase 2 study in ovarian clear cell carcinoma. ENMD-2076 has received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia.
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, a Phase 2 study of ENMD-2076 in advanced/metastatic soft tissue sarcoma, and is expecting to initiate a Phase 2 study in ovarian clear cell carcinoma. 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).
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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