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EntreMed, Inc. (ENMD) Announces FDA Acceptance of Company’s IND Application

EntreMed, Inc. (ENMD), a clinical-stage pharmaceutical company that develops medication for the treatment of cancer and inflammatory diseases, announced that the U.S. Food and Drug Administration accepted the company’s Investigational New Drug Application for their Panzem(R) (2-Methoxyestradiol or 2ME2) product. This product is able to treat patients suffering from rheumatoid arthritis.

Rheumatoid arthritis is a chronic inflammatory disease. This disease is often characterized by significant joint lining, aberrant angiogenesis, and progressive joint damage. EntreMed’s Panzem drug consists of a small metabolite of 17beta-estradiol, able to counteract most side effects correlated with Rheumatoid Arthritis.

Carolyn F. Sidor, M.D / M.B.A and EntreMed’s 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, added, “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.”

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