November 3, 2008
Antiangiogenic Role of 2ME2 Demonstrated in Rheumatoid Arthritis Models
ROCKVILLE, Md., Nov. 3 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the publication of preclinical results for 2ME2 (Panzem(R) or 2- methoxyestradiol) in rheumatoid arthritis (RA). The results of the study, conducted by EntreMed collaborator, Dr. Ernest Brahn, Professor of Medicine, Rheumatology Program Director, David Geffen School of Medicine at UCLA, were published in the November 2008 issue of the Journal of Rheumatology (Brahn E, Banquerigo ML, Lee JK, Park EJ, Fogler WE, and Plum SM. An angiogenesis inhibitor, 2-methoxyestradiol, involutes rat collagen-induced arthritis and suppresses synovial VEGF and bFGF gene expression. J Rheumatol 2008;35:2119- 28).
(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )Results from treatment studies in a preclinical model of established rheumatoid arthritis demonstrated that daily oral administration of 2ME2 suppressed both clinical and radiographic indicators of joint inflammation and damage, including soft tissue swelling and bone erosion. The treatment benefits of 2ME2 were dose-dependent and associated with reduced joint expression of the prominent angiogenic growth factors, FGF-2 and VEGF, as well as decreased angiogenesis. The report further demonstrates both a delay in onset and decrease in severity of arthritis if 2ME2 treatment is started prior to disease initiation. These results indicate that 2ME2 may represent a novel agent for treatment of inflammatory autoimmune diseases such as rheumatoid arthritis and identify 2ME2 as a disease modifying anti-rheumatic drug (DMARD).
Dr. Brahn commented on the outcome of the study, "These results demonstrate the beneficial effect of 2ME2 in managing disease progression in preclinical models of rheumatoid arthritis. Furthermore, these results indicate that 2ME2 may represent a novel agent for the treatment of rheumatoid arthritis through its inhibitory activity on inflammation and angiogenesis."
Kenneth W. Bair, Ph.D., EntreMed Senior Vice President, Research & Development, further commented, "These data continue to support the potential therapeutic benefit of 2ME2 for the treatment of inflammatory diseases such as rheumatoid arthritis. 2ME2 is an oral, small molecule, disease-modifying anti- rheumatic drug with an excellent safety profile established through daily dosing in more than 300 cancer patients, some for over 5 years. The Company has initiated clinical activities to support 2ME2 in RA, including the completion of a healthy volunteer study. Results of the healthy volunteer study have been submitted to the FDA and, once feedback has been received, we will determine the appropriate next steps for continuing the 2ME2 RA clinical program."
About Rheumatoid Arthritis
Rheumatoid arthritis affects over 2 million American adults, of which about two-thirds of them are women. The disease, characterized by pain, stiffness, swelling, and deformity can become debilitating. Within 5 years of diagnosis, a third of patients are no longer working, and within 10 years, half of the patients have substantial functional disability. RA can shorten life expectancy by 5-10 years.
Rheumatoid arthritis, one of the most common forms of arthritis, is a systemic disease characterized by inflammation of the membrane lining of the joint, which causes pain, stiffness, redness, swelling, and loss of function in the joint. The inflamed joint lining, called the synovium, releases enzymes that destroy bone and cartilage, causing the joint to lose its shape and alignment. This process can result in joint pain, loss of movement, and deformity. DMARDs are drugs that have the ability to slow down disease progression in rheumatoid arthritis and other autoimmune diseases.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1, an oral cell-cycle regulator with activity against the mTOR pathway, is currently in multiple Phase 2 clinical trials for cancer. ENMD-1198, a novel antimitotic agent, and ENMD-2076, a selective kinase inhibitor, are in Phase 1 studies in advanced cancers. The Company also has an approved IND application for Panzem(R) in rheumatoid arthritis. EntreMed's goal is to develop and commercialize new compounds based on the Company's expertise in angiogenesis, cell cycle regulation, cell signaling and inflammation - processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company's web site at http://www.entremed.com/ and in various filings with the Securities and Exchange Commission.
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 (including the timing of royalty revenues and future R&D expenditures), 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 those set forth in Securities and Exchange Commission filings under "Risk Factors," including risks relating to the need for additional capital and the uncertainty of additional funding; variations in actual sales of Thalomid(R), risks associated with the Company's product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results, uncertainties relating to preclinical and clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).
CONTACT: Ginny Dunn EntreMed, Inc. Associate Director Corporate Communications & Investor Relations (240) 864-2643
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CONTACT: Ginny Dunn of EntreMed, Inc., Associate Director CorporateCommunications & Investor Relations, +1-240-864-2643
Web site: http://www.entremed.com/