ROCKVILLE, Md., Dec. 4, 2012 - EntreMed, Inc. (ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, announced today that preclinical results for its compound 2-methoxyestradiol (2ME2) were published on line in this week’s Early Edition of Proceedings of the National Academy of Sciences (PNAS). The study was conducted at The Campbell Family Institute for Breast Cancer Research at Princess Margaret Hospital and was led by Tak W. Mak, Ph.D.
Tak W. Mak, Ph.D., Director, The Campbell Family Cancer Research Institute, commented on the study, “Multiple sclerosis (MS) is among the most common autoimmune disorders in the northern hemisphere. There exists significant unmet medical need for safe and effective drugs to treat MS. In this study, we demonstrated that 2ME2, an endogenous metabolite of estradiol, significantly inhibits lymphocyte activation and proliferation and dramatically suppresses development of experimental MS. Our analysis of cellular signaling pathways further reveals that 2ME2 exerts a potent inhibition of Nuclear Factor of Activated T cells (NFAT). By extension, the study provides for the first time a molecular rational for the use of 2ME2 as a tolerable oral immunomodulatory agent for autoimmune disorders such as MS. Other studies have shown that in humans, plasma levels of 2ME2 may increase dramatically during the last months of pregnancy, which intriguingly appears to correlate temporally with the remission of clinical symptoms reported in some pregnant MS and rheumatoid arthritis (RA) patients. We believe that 2ME2 may offer a safe and effective treatment for such autoimmune disorders.”
Ken Ren, Ph.D., EntreMed’s Chief Executive Officer further commented, “In addition to ENMD-2076 for oncology, 2ME2 represents another important asset for our company with its strong IP position and sound safety profile. Together with our previous findings of its disease modifying activity in RA animal models, this study further extends 2ME2’s therapeutic value to the management of MS, RA and possibly other autoimmune disorders.”
Dr. Ren continued, “We appreciate the international recognition by our peers. For the next step, we intend to further advance 2ME2 development as part of our global drug development plan and strategy to leverage resources both in the US and China. We are currently exploring multiple strategies for the development of 2ME2 including possible partnership opportunities. We believe that the development of 2ME2 for autoimmune diseases fits well with our plan to build a robust product pipeline and to add value for our long term shareholders.”
The article is entitled “2-Methoxyestradiol inhibits experimental autoimmune encephalomyelitis through suppression of immune cell activation” and was authored by Gordon S. Duncan, Dirk Brenner, Michael W. Tusche, Anne Brustle, Christiane B. Knobbe, Andrew J. Elia, Thomas Mock, Mark R. Bray, Peter H. Krammer and Tak W. Mak. The article is available at http://www.pnas.org/content/early/2012/11/30/1215558110.
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 is the subject of a successful IND filing for clinical use to treat RA. 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; 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.