EntreMed Announces FDA Acceptance of IND Application for Panzem® in Rheumatoid Arthritis
ROCKVILLE, MD - December 11, 2007 - EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for Panzem(R) (2-Methoxyestradiol or 2ME2) in rheumatoid arthritis (RA).
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by a proliferating synovium (joint lining), aberrant angiogenesis, and progressive joint damage. Panzem(R) is a small molecule metabolite of
17beta-estradiol which, in its purified form, has antiproliferative, apoptotic, and antiangiogenic activity. These properties make it of particular interest in various diseases characterized by abnormal cellular proliferation and angiogenesis.
In three distinct preclinical treatment models, oral administration of Panzem(R) demonstrated antiarthritic activity when treatment was initiated following disease progression. In these therapeutic intervention models, arthritic activity was attenuated and joint damage arrested as assessed by histology or radiography. When Panzem(R) was administered early following disease initiation, there was a dose-dependent inhibition of arthritic activity (measuring evident edema and inflammation) and, in one model, a delay in the onset of disease. Furthermore, using an early intervention model, Panzem(R) combined well with methotrexate, a current standard of care RA treatment, resulting in additive antiarthritic activity. The results of these studies demonstrate that Panzem(R) is a DMARD (disease modifying antirheumatic drug) that inhibits the principal symptoms of the disease, including cartilage lesions, bone resorption, cellular infiltration, and pannus formation.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented, “The cross over of agents used to treat cancer into the treatment of patients with RA is well established with methotrexate being the mainstay of RA therapy. Panzem(R) is a potentially safe, orally-administered, small molecule drug candidate that could contribute to the treatment paradigm for patients with RA. Based on Panzem(R)‘s demonstrated safety profile and activity in oncology patients, its mechanism of action, and its activity in preclinical RA models, we believe that Panzem(R) will be of considerable interest to clinicians as a potential treatment for RA.”
James S. Burns, President & CEO, also commented, “Acceptance of the IND for Panzem(R) in RA represents the completion of a key development milestone and adds another asset to our pipeline. Our strategy moving forward will be to initiate early clinical trials internally and then seek a development partner for larger multicenter clinical trials.”
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 (RA), 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.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) NCD (2-methoxyestradiol or 2ME2) is currently in multiple Phase 2 clinical trials for cancer. MKC-1, an oral cell-cycle regulator, is in multiple Phase 1 and 2 studies for cancer. ENMD-1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. Panzem(R) has an approved IND for rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, is in preclinical development for cancer. EntreMed’s goal is to develop and commercialize new compounds based on the Company’s expertise in angiogenesis, cell-cycle regulation 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 www.entremed.com and in various filings with the Securities and Exchange Commission.
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).
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