2ME2 patent strengthens EntreMed's position in cancer and non-oncology diseases.

EntreMed, Inc. (Rockville, MD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, announced the issuance of United States Patent 7,012,070 covering methods of treatment for a broad range of indications with its lead clinical-stage compound, 2-methoxyestradiol (2ME2). Panzem NCD, an oral formulation of 2ME2, is currently in Phase 2 clinical trials for cancer. Panzem is also in preclinical development for rheumatoid arthritis.

United States Patent 7,012,070, entitled "Estrogenic Compounds as Anti-Mitotic Agents," contains claims granted by the United States Patent and Trademark Office covering 2ME2 for the treatment of multiple indications, including cancer and inflammatory disorders such as rheumatoid arthritis. The patent claims cover methods of treating a broad range of disease indications with 2ME2 that is independent of mechanism, including solid tumors or tumor metastases, immune and inflammatory diseases, including rheumatoid arthritis. The patent is owned by Children's Hospital Boston and licensed exclusively worldwide to EntreMed.

Panzem (2ME2) is a novel anticancer agent, which is part of a next generation of antimitotic cancer drugs that bind to tubulin and work through multiple cellular pathways. 2ME2 can attack tumors on multiple fronts -- directly by disrupting microtubules, an intracellular matrix necessary for the rapid division of cancer cells (mitosis), by inducing programmed cell death (apoptosis), and by blocking blood vessels that feed tumors (angiogenesis inhibition).

Angiogenesis is also an integral component of the rheumatoid arthritis (RA) disease process. Results from preclinical studies support the potential for 2ME2 as a disease modifying anti-rheumatic drug (DMARD). Antiarthritic activities of 2ME2 were observed in both preventive (prior to arthritis onset) and treatment studies (active arthritis). When 2ME2 was administered in the preventive setting, the onset of arthritis was delayed significantly. When 2ME2 was administered in the disease treatment setting, there was marked inhibition of tissue and joint damage. The beneficial effects of 2ME2 in RA models were dose-dependent and non-immunosuppressive.

James S. Burns, EntreMed President & CEO, commented, "EntreMed is focused on the development of a new generation of small molecule drugs for the treatment of cancer and inflammatory disorders by attacking disease cells directly and the blood vessels that nourish them. This patent further expands our intellectual property coverage for 2ME2, our lead multi-mechanism drug candidate currently in Phase 2 clinical trials for cancer."

Mr. Burns further commented, "We have increasing evidence that 2ME2 has both antitumor and antiinflammatory properties, providing us with potential opportunities to treat cancer and rheumatoid arthritis. We are committed to developing a strong intellectual property position for this compound based on a portfolio of composition, method, use and formulation patents."

EntreMed is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem (2-methoxyestradiol or 2ME2), the company's lead drug candidate, is currently in Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, recently acquired through the company's acquisition of Miikana Therapeutics, is also in Phase 2 studies 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.

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